1. Student INTRA Report
Name
Ian Martin
Student ID
11532343
Degree Programme
Genetics & Cell Biology (GCB)
Faculty
School of Biotechnology
Year
3rd Year Undergraduate
Company
Eli Lilly

2. Abstract
Eli Lilly is an American pharmaceutical manufacturing company situated near the
scenic seaside town of Kinsale Co.Cork. Today Eli Lilly Kinsale manufactures 9 different
small and large molecule products on its expanding 140 acre parkland site. The company
offers INTRA students relevant lab bench and desktop work experience connected with their
course. One’s role as a Quality Control laboratory (QCL) analyst entailed of performing
experimental analysis in the analytical lab, GMP documentation and project work which
required oral presentation. While chemistry tests conducted were not totally applicable to
DCU’s Genetics and Cell Biology degree, the opportunity to learn and perform these tests
was an awarding and educational experience.
Ultimately these lab bench and desktop skills will compliment one’s biology degree
and benefit future employment. In addition Eli Lilly provided one the chance to visit large
scale manufacturing facilities on site, training in a variety of areas and help in finding
accommodation in Cork. Its internship programme is unique as there are up to 20 other
undergraduate students on site during the summer months. This provides social interaction
and an opportunity to take part in many extracurricular activities provided by the company's
very active sports and social club. One feels fortunate to have experienced industry for the
first time in Eli Lilly and would highly recommend this internship to future DCU students.

3. Introduction
Purpose of the Job
The primary purpose of an Eli Lilly Quality Control laboratory (QCL) analyst is to
ensure that raw materials used in experimentation and Active Pharmaceutical Ingredients
(API) produced in Eli Lilly Kinsale are safe for patient use and adhere to the guidelines
stipulated by international drug authorities. This fundamental objective is achieved by
carrying out a broad range of analytical tests on Eli Lilly products and examining specific
parameters such as particle size, potency and water content to confirm products are fit for
purpose. One’s specific lab purpose was to carry out a qualitative IR analysis of API and
determine if any notable impurities were detectable in each drug batch. Additional objectives
connected with one’s placement in QCL included:
 Improving and addressing safety practices in the lab.
 Implementing efficient management and archiving of documents.
 Enhancing handling and disposal of reagents and samples.
Company History Structure
Eli Lilly is an American pharmaceutical company founded in Indianapolis in 1876 by
civil war veteran Colonel Eli Lilly. From its modest beginnings over 100 years ago in a small
pharmacy in downtown Indianapolis, Eli Lilly Company has grown to become the 10th
largest
pharmaceutical company in the world employing 38,0000 employees globally. Eli Lilly sells
its wide-range of pharma products to 140 countries and generates revenues of over $20
billion dollars a year.
Eli Lilly’s Irish manufacturing facility is located at the periphery of the picturesque
and historical seaside town of Kinsale. Operations in Eli Lilly’s Cork branch commenced in
1981 and the site now occupies 140 acres of land with a workforce over 600 employees. The
focus of the Kinsale facility is to develop, manufacture and finally supply a variety of
medicines found in Eli Lilly’s extensive portfolio. The site utilizes a wide array of chemical
and biological processes to provide a selection of API that can be shipped to finishing plants

4. where they are converted to tablets, capsules or injectables, depending on the drug's approved
dosage form.
Small & Large Molecule Operations
Kinsale has played a central role in the commercialization of small molecule APIs
throughout its 30 year history. Today the site endeavours to be one of the most important
suppliers of API for newly launched Lilly medicines. In conjugation with chemical product
development Kinsale continues to be instrumental in late phase product optimization, which
includes technical transfers, scale-ups and clinical trial API manufacture.
Kinsale Eli Lilly has been constantly evolving throughout its existence and current
manufacturing operations are aligning with the dynamic environment of the
biopharmaceutical industry. In 2006 Lilly announced that the Kinsale would become a hub
for production and supply of API for new bio pharma products. This transition from small to
large molecule has allowed the site to diversify into new biotechnology fields to produce
innovative monoclonal antibody therapies.
A new state of the art 240,000 square foot Bio-pharma facility is currently being built
on the existing Kinsale site. The new IE43 building will cost in the region of €330 million
when complete and will require an additional 300 employees when fully operational in 2017.
The new unit will focus on providing new biopharmaceutical therapeutic treatments for
cancer and diabetic patients.
Basic Overview of Small Molecule Processes
Small molecules API are manmade chemical entities derived from synthetic reactions that
result in new therapeutic molecules. The basic overview of small molecule production can be
broken into 4 stages:
 Reactions
 Purification
 Isolation
 Analysis

5. Reactions: Solvents and reagents are added in distinctive product specific manner to
synthesise API molecules.
Purification: During this refinement stage, the desired API is separated from impurities such
as intermediates and residual solvents which are by-products of chemical synthesis.
Isolation: Isolation is the final stage of the purification process whereby the target API is
totally segregated. Drying, filtration and centrifugation are some of the most used techniques
to separate out desired API.
Analysis: The last part of small molecule production consists of examining the various
parameters of the manufactured molecule to ensure that it conforms to FDA standards. This
stage of the process is the responsibility of the Quality Control department and is where one
performed their duties on placement.
Duties performed
Duties executed in QCL included:
SOP training
Reading and electronically signing off of Standard Operational Procedures SOPs.
Safety Data Trending
Evaluating safety observations in the Bio, Micro and Analytical labs.
Final Product Campaign Review
Forming reagent/equipment lists for final products testing.
Lab maintenance
Restocking Personal Protective Equipment and cleaning of the lab.
Documentation & Archiving
Archiving Equipment files, storing Control Charts and implementing a T Card system.

6. Reagent Check
Reviewing expiry dates and disposing of expired reagents.
Waste Deposal
Clearing of waste materials from the lab.
Debagging
Transferring API from secondary containment for lab use.
API IR Analysis
Performing Infrared Spectra Analysis on API molecules.
SOP Training
Prior to carrying out any laboratory activities or partake in any documentation
practices, Lilly Kinsale employees are required to acquaint themselves with all relevant Lilly
methods connected with their work. This familiarization process involved the reading of an
encyclopaedia of Standard Operational Procedures (SOP). During the first week of one’s
placement there were over 100 hundred SOPs to be completed before certain tasks could be
carried out. One appreciates that by reading these documents a greater understanding of
operations at Lilly were attained and thus improved overall performance.
Safety Trending
It is a mandatory requirement of all Lilly employees to abide by the Kinsale’s site
health and safety practices in order to maintain a safe work place. Lilly‘s commitment to
safety is best illustrated by its interactive B-SAFE software which encourages employees to
be proactive in recording positive and negative safety observations. It was ones’ duty to
categorise these entries and evaluate if any trends were apparent. The findings were then used
to drive discussion at safety committee meetings and resolve safety issues.
Product/Intermediate Campaign Inventory

7. Kinsale Lilly products are produced and rolled out in a coordinated campaign
strategy. QCL testing is directed by campaign production scheduling and deadlines must be
met so batches can be released. Protocols from every campaign were reviewed and the
necessary reagents needed for testing were displayed in a Microsoft spreadsheet which was
freely available to the QCL staff. As a result of one’s documentation QCL staff could easily
review and checklist inventory required for experimentation.
Lab Maintenance
PPE
The QCL department in ELI Lilly is run 24 hours a day resulting in lab consumables
such as nitrile gloves and lab coats being continually used. The availability of these items is
important as all testing performed by lab analysts require specific protective apparel in order
to safeguard them from potential contamination and mutagenic chemicals. For this reason it
was one’s task to check that consumables were routinely restocked and obtainable for over 20
analysts working in this busy lab. Specifically this required one to monitor lab equipment on
a daily a basis and visit the store room to replenish supplies that were low or out of stock.
Waste Disposal
The disposal of contaminated materials was a fundamental job carried out on
placement and involved organizing a spectrum of waste into specific disposal units. Non-
toxic waste material such as nitrile gloves were disposed of in regular plastic bin bags.
Contaminated material which accumulated in the fume hoods were placed into protocol bags
and then placed in blue drums also. Glassware and various sharps such as needles were
placed into specialised non-resalable yellow plastic boxes. Solvent glassware was directly
dumped into a glass recycling units and similarly mixed dry materials such as cardboard were
also recycled.

8. Documentation & Archiving
Control Charts
One of the key tasks allocated to oneself during placement involved the archiving of
lab control charts into electronic form. Laboratory control charts are used to graphically
monitor patterns of analysis for short and long-term QC processes. The purpose of scanning
these important charts was to avert the potential loss of the chart and make the document
more available to staff.
Equipment Folders
The QCL houses 100’s of analytical instruments that require continual maintenance
and monitoring. Records of out of use instruments were archived or disposed of in
accordance to SOPs.
T Card System
The QCL department contains notebooks which hold the results all tests carried out in
the lab. These notebooks are routinely passed from analyst to analyst during documentation
procedures including 2nd
person verification. It is vital that notebooks can be quickly accessed
to facilitate such review processes and are readily available during audits. It was one’s duty to
implement a simple T-Card system in order to track down the whereabouts of each notebook.
A department coloured T-card was placed inside every notebook and a noticeboard
displaying every analyst name was erected. If an analyst was in the procession of a particular
notebook it is their responsibility to indicate this on the noticeboard by placing the relevant
T-Card by their name.
Reagent Check & Reagent List
The QCL laboratories contain a broad variety of analytical reagents which are needed
for the analytical assays carried out in the lab. For these tests to satisfy criteria stipulated in
lab protocols it is critical that all reagents to be used are in date. The regular assessment of
reagent and solvents expiration dates was a responsibility one undertook during placement.
Reagents were checked for expiration by referring to their supplier’s website and inputting

9. details batch details connected with that reagent. A reagent list was also compiled for entire
analytical lab.
Disposal/Transfer Procedures of various Chemicals
An allotted lab duty that one carried out was the safe disposal and transfer chemicals
in accordance to particular SOPs. This task allowed one to identify the various safety hazards
associated with materials such as oxidizing materials and organic solvents.
Debagging
Before any analytical tests were conducted on production samples, one had to transfer
batch samples from secondary containment into suitable bottles as detailed by specific SOPs.
The transfer of batch samples from secondary containment to final testing vessels was an
important step in the QCL lab as it was is the first time a sample from a particular batch
entered the lab for testing. For this reason it is imperative that the debagging procedure was
correctly performed as the identity of the sample cannot be questioned due to improper
handling and labelling.
Infrared Spectrometry
Infrared Spectrometric testing was one’s allocated test in QCL. The purpose of the analysis
was to perform a quick qualitative investigation of what functional groups and impurities
were found in given API molecule. The underlying principle behind the technique is that
specific bands of infrared light interact with molecules to give off detectable vibrations of
atoms. Based on specific bond vibrations and rotational frequencies one can determine
functional groups within a molecule by evaluating an IR spectrum of these energy profiles
over a given wavelength range. The basic method consists of Potassium Bromide being
combined with the powdered API. This mixture is then compressed into a fragile thin disk
and placed into an IR instrument where various waves of light are directed at the sample. One
was also trained on a handheld variant of this technique RAMAN Spectra analysis.
IR Analysis was a highpoint of placement as it was first time that one had carried out a
scientific experiment that had significance in the real world outside the college .As one

10. performed IR spectra analysis one appreciated that knowledge gained about GDP, health
safety and other training molecules were of relevance when performing this task
Knowledge Gained
Good Document Practice (GDP)
One of the biggest learning outcomes working in QCL was implementing Good
Document Practices (GDP) in accordance with guidelines set out by regulatory authorities. In
a Good Manufacturing Pratice (GMP) Environment it is fundamental that documentation
meets certain requirements to ensure product quality and safety. One has learnt that
documentation provides a detailed account of when, where, who, why and how tasks inside
and outside the lab were completed. This documentation process provides conclusive
evidence that tasks were completed as they should be.
A useful aspect of GDP that will benefit one in the future is the proper maintenance of a lab
notebook. Expiry dates of reagents, days tests are run, temperatures of solutions, weights of
materials and sample identification codes are some of the key details that must be recorded in
a lab notebook. A notebook with accurate descriptions of observations provides clear and
concise data that can be reviewed and understood in the future if required. Correcting
inscribed mistakes in documentation was a time consuming, difficult and at times frustrating
experience but one’s neatness and note taking has improved immensely.
One understands the standard of documentation within a company such as Eli Lilly
can directly influence the level of success in manufacturing quality products and audit
reviews. One gained an appreciation how second person verification which is the review of
GDP documents by fellow analysts is vital to ensure official papers are documented properly
.Ultimately GDP practice has entered a new era in Eli Lilly whereby paper documentation is
now being replaced by electronic records. One understands that electronic capturing data on
an analytical instrumentation and connecting wirelessly to computers will become the new
norm in industry and is the future of GDP.
Computer Systems

11. QCL uses computer systems Smartlab, Darwin, and Empower to coordinate
experiments, document results and manage samples in the lab. The collective term for the 3
systems is LIMS (Laboratory Information Management Systems) and they play an imperative
role in providing transparent audit trails and improving operational efficiency in QCL.
Darwin
Darwin enables the safe management of data connected with received batch samples in the
lab by providing an electronic audit trail. Darwin ensures tests conducted in the lab comply
with regulations and internal quality standards of Eli Lilly.
It contains a reservoir of information about samples including:
• QCL sample registry
• Trending details about stability samples.
• Test methods and specifications.
• Result entry management
One experienced first-hand the usefulness of Darwin when debagging API products. Using
the unique bar code labels placed on the outside of each debagged sample one observed the
tracking capabilities of such software when scanning and registering these samples into the
lab. Once logged onto the Darwin system one could monitor the status of the sample and
location where the sample is stored. This monitoring capacity was useful when disposing of
analytical and reference samples because one could whether determine if all testing had been
completed lab.
Smartlab & Balance Calibration
Smartlab is a fully validated computer system that has a range of abilities including:
• Inputting and storing experimental data.
• Monitoring overall experimental progress of batches.
• Accessing the limit criteria of experiments.
• Facilitating wireless connectivity with instruments.

12. • Providing transparent audit trails.
The basic purpose of Smart lab is to reduce documentation errors and better facilitate
regulatory audits. It diminishes the need for paper as samples are tracked and documented
throughout the analysis process. The audits trails produced in Smart lab allow one to view,
calculations and supporting data of each analysis of samples. Smart lab accommodates faster
2nd Person verification processes by containing built in limits. These parameters allow the
software to identify tests that are outside specification limits for an experiment.
A good example which illustrates the practicality of Smartlab is its use regarding
capturing and calibration of balances. As eluded to previously GDP is entering a new period
where wireless electronic documentation between computer systems and lab equipment will
be industry standard. Balances can connect wirelessly to smartlab when capturing data and
weights of samples used for testing. Furthermore daily calibrations are also stored in this
manner using Smart lab. Ultimately this method further enhances the validity of testing and
transparency when subject to audits.
Empower
Empower is a software that allows users to control chromatography instruments and
process data. While one did not directly use this software one must acknowledge the
convenience of this software when running samples. One example of its usefulness is that
Empower allows analysts to program chromatography runs overnight so results can be
integrated and interpreted the next day thus saving time and money.
Teamwork Communication and Time Management
Not only did one learn numerous lab techniques but working in the QCL department allowed
the acquisition of teamwork, communication and time management skills. One now
understands that having these abilities is vital in any working environment and will be of
benefit in one’s future career.

13. Teamwork
Many hands make light work is an expression that could be defined by the teamwork
that is evident in QCL labs. API Batch authorization requires a range of analyses to be
conducted on each sample. By delegating work these tests can be carried out in the most
efficient and effective manner thus streamlining the QCL assessment process. In addition one
of the advantages of working in a team is its capacity to solve problems. If an issue did arise,
one could consult with a collection of other analysts and overcome the problem in the best
manner.
Communication
One improved their communication skills by continually reporting to team leaders,
collaborating with supervisors and interacting with analysts in the QCL department. The
ability to: speak appropriately with a wide variety of people whilst maintaining good eye
contact, demonstrate a varied vocabulary and tailor your language to your audience, listen
effectively, present your ideas appropriately, write clearly and concisely and work well in a
group are good communication skills one acquired inside and outside the lab.
A basic area of communication that one assimilated beneficial experience was
presentation making. Attending weekly and monthly meetings allowed one to watch senior
analysts talk about their work in a professional manner and answer questions in an
informative concise style. One also received presentation training in which the elements that
make an engaging and memorable presentation were taught. Presentations were always
something that one was reluctant to perform before the placement commenced however
having delivered presentations to various department forums, one now enjoys conveying
presentations to large audience
Time Management

14. A central skill one acquired was how to plan your day and identity tasks that need to
be completed. This was a major learning experience during placement and one’s ability to
prioritise jobs definitely aided completion of tasks. A significant lesson one learnt is the
ability sometimes to say “no” when you have already a considerable amount of work to do.
While being enthusiastic and helpful is a great characteristic to have, it’s better to complete
important tasks correctly and on time than rushing through minor work that will hinder more
imperative tasks.
Safety Training
Safety is of utmost importance to Eli Lilly, therefore it is mandatory that every Lilly
employee is trained correctly so they can carry out their work in the safest manner. The
mandatory training that one received included:
• Manual Handling & Ergonomics
• Fire Safety Training
• Eye Protection and Treatment (Diphoterine) Training
• Evacuation Training
Manual Handling & Ergonomics:
Training consisted of a practical session teaching the proper handling of heavy
equipment. The training conducted demonstrated the consequences of wrongly lifting large
objects and one learnt of the various injuries that can result of mishandling.
Fire Safety Training
One was informed during fire safety training that different types of fire require
different types of actions to extinguish them. Ultimately one learned by eliminating the
parameters of the fire triangle as depicted in figure a fire can be stopped.
Eye Protection Training

15. As part of eye protection safety one learnt that in the event of chemical exposure to
the eye Diphoterine is an adequate eye decontamination solution .Diphoterine is hypertonic,
polyvalent, amphoteric compound which neutralises approximately 600 chemicals.
Diphoterine can prevent eye/skin burns following chemical splashes and results in nearly
immediate pain relief.
Evacuation Training
In the evident of an unlikely accident occurring on site one was educated on how to
respond to an emergency situation. Eli Lilly employ a practice of Shelter in Place if a harmful
chemical is emitted into external environment .One is recommended to stay indoors in order
to separate individuals from the hazardous outdoor gases.
pH Calibration Training
The pH calibration practice employed in Lilly ensures that the tuning of a respective
meter is at an optimal setting to produce a more accurate and efficient reading when
measuring the pH of a solution. An interesting observation one learnt about the calibration
process was that temperature is a critical parameter that has to be monitored during the entire
pH meter standardization procedure. Throughout the pH measurement of buffers and
solutions temperature is recorded simultaneous using a temperature probe. One learnt that the
purpose of this practice was that temperature can adversely reduce the accuracy and speed of
response of a pH electrode.
Shadowing
During placement one had the opportunity to shadow a range of chemistry set ups in
the analytical lab. One gained theoretical and practical knowledge connected with each
instrument by observing and questioning analysts during experimentation. The chance to
witness these experiments was seized upon because many of the experiments in the lab were
not touched upon during one’s biology degree. Thus one has gained a great insight of how to
operate the following instruments:

16. • Chromatography (HPLC & GC)
• ICP Spectrophotometer Operation demonstration
• Scanning Electron Microscope (SEM)
• NMR Operation demonstration
• Particle Size analysis demonstration
• Water (Analysis Karl Fischer Water Titration LOD)
Chromatography
High Performance Liquid Chromatography HPLC
HPLC is the most common experimental technique utilised in the analytical lab and
was among a few tests that one that had some previous college exposure. The most beneficial
outcome following shadowing of the HPLC was how to troubleshoot problems. What do you
do if ghost peaks appear? How to eliminate bubbles in the system? What to do if pressure is
building the instrument? How can you avoid leaks? These are just some of the issues one
encountered during observing the running of a HPLC instrument. Touching upon these topics
is the definition of what hands on experience is about because no textbook can communicate
years of practical knowledge acquired by analysts in the lab. Its HPLC tips and tricks like
washing a column after use to prevent future problems that have deepened one’s knowledge
from a practical perspective the use of this typical industry instrument.
Gas Chromatography (GC)
Similarly just like HPLC above, GC analysis was among a few experiments that one
had encountered briefly during college practical sessions. The main take home point after
shadowing many GC experiements is the importance of using clean glassware. GC analysis is
a highly sensitive method and picks up any unwanted contaminants resting on glassware.
Under supervision one was shown how to properly clean glassware using detergent
formulations stipulated in SOPS. During this cleaning procedure one acquired the ability of
using a simple bulb pipette.
Inductively Coupled Plasma (ICP) Spectrophotometer

17. ICP Spectrometry was one of the many instruments that one had no previous
knowledge of before entering Eli Lilly. The purpose of the instrument is to measure trace
metal elements in a variety of drug preparations. The basic concept underpinning the method
is that superheated plasma, which is at a temperature of 10,000K, vaporises samples until
they radiate excited atoms and ions. These emitted energized photons and electrons create
detectable electromagnetic wavelengths that are characteristic of particular trace elements.
One recognizes from a learning perspective the use of such an instrument is important to
detect toxic heavy metals that are potentially detrimental to patient safety.
Scanning Electron Microscope SEM
SEM analysis employed by QCL examines the crystal structure and conformation of
intermediate and final drug products. The high resolution 200,000 magnification of the
microscope enables users, to determine if unwanted crystalline clumping has occurred during
production crystallisation processes . This capacity to visualise materials that are as small as
2um in size allows a microscope operator the opportunity to detect any visible impurities or
foreign material in a given sample. From a practical perspective one was intrigued to see
microscope manipulation was joystick controlled. One had only encountered simple light
microscopes during college so observing careful microscope handling using a joystick device
was an educational experience.
Nuclear Magnetic Resonance NMR
The most complicated instrument that one was exposed to in the lab was the Nuclear
Magnetic Resonance (NMR) spectrometer. In the most simplistic of terms this instrument
measures electromagnetic radiation emitted by nuclei spinning in the presence of a given
magnetic field. This analytical technique is used for product identification testing to ensure
that the content, purity and molecular structure of given API meet quality assurance
standards. From a biology viewpoint one appreciates the use of the instrument to quantitate
protein feed components and metabolites in mammalian cell culture. This type of testing is
known as large molecule fermentanomics quantization and was a feature of the instrument
one found hugely engaging.

18. X-Ray Diffractometry
One now understands the significance of crystallographic analysis in regards
accessing the molecular bonds within drug products. The structure of given molecule must be
the correct configuration to interact properly with its cellular target. This can be achieved by
examining the geometry of bonds within an API using an X-Ray Diffractometer .After
shadowing an analyst using this instrument one has acquired the theoretical background of
how the instrument operates. A narrow X-Ray beam emitted from a source copper is directed
at a drug sample. This radiated X-Ray beam produces a characteristic wavelength which
scatters once it interacts with the crystalline structure of a given sample. The X-Ray energy
resulting from this diffraction process can be measured using a scintillation counter.
Particle Size Analysis
The need for particle size analysis during pharmaceutical manufactory is of upmost
importance because it ensures milling processes during production are effective. Small
molecules need to be of the correct size to cross membranes in order to interact with
intracellular targets. Particle size analysis allows users to evaluate if wet and dry samples
measuring 10 nanometers to 5 millimeters are of the correct size. The central idea behind this
form of analysis is that a particle will scatter light from a laser at particular angles. In theory
larger particles will scatter at small angles and smaller particles scatter at wide angles. One is
now aware of how the instrument operates and significance of particle size in relation to
bioavailability.
Karl Fischer Titration
The Karl Fischer titration method is one of the most common experiments carried out
on a daily basis in the QCL labs in Lilly. The main objective of a Karl Fischer instrument is
measure the water content found in an intermediate or API. The basis of this technique is that
samples are heated by the oven and carrier gas facilitates the transfer of released water
vapour into the KF titration cell. One found out that in industry if a product had more than
likely low moisture content this is the preferred method of analysis.

19. Loss on Drying (LOD)
Another test which evaluates moisture levels is LOD testing. This is a crude
alternative to Karl Fischer titration and also evaluates alcoholscontent. Loss on Drying
compares the weight of a product before and after it is dried. This difference in weight is
taken as the percentage of moisture in the product. One was trained on this method.
Large Molecule Production and Testing
During the latter weeks of placement one was fortunate to gain exposure of large
molecule production and testing. One received a tour of the IE42 facility where
Ramucirumab and other therapeutic monoclonal antibodies are manufactured. During the
following section one will discuss briefly large scale bioprocessing which can be broken into
upstream and downstream practices.
Upstream (Cell Culturing)
Upstream bioprocessing starts by thawing genetically engineered cells, which carry
DNA sequences of therapeutic proteins. Once cells are defrosted from a frozen state they are
cultured in large bioreactors over a period of weeks. During this culturing process product
producing cells are gradually scaled up in larger vessels and are regularly inoculated with
larger quantities of media. The final stage of the upstream processing involves high speed
centrifugation and filtration separating unwanted cell matter from the therapeutic proteins
that have been secreted in solution.
Downstream (Cell Purification)
The aim of the downstream process is to purify the clarified protein solution to a
degree which is compliant with product quality standards and ensure the correct
concentration of therapeutic proteins is obtained. In addition any non-infectious viral

20. components which accumulate during the culturing process are removed. The initial
purification consists of column chromatography whereby the protein solution is passed
through a filter resin. This step is followed by virus inactivation which is carried out by
filtering viral particles using a fine mesh. The final stages of the purification consists of is
ultra-filtration which concentrates proteins into its final formulation.
Observing the upstream and downstream bioprocessing of IE42 was a major highlight
of ones time in Eli Lilly. It was a unique experience to see large scale ups of some the basic
procedures that one had encountered in college labs. From observing the bioprocessing one
has gained a greater knowledge and a new appreciation of column chromatography and
engineering surrounding bioreactors. Another important learning outcome was the
importance of maintaining a sterile environment when growing and purifying cells. Cell
culture conditions used during upstream bioprocessing provide an optimal environment for
opportunistic bacteria to flourish. Likewise the transfer of sample from purifying step also
presents risks to contamination. For these reasons strict gowning procedures and regular filter
inspections are performed to eliminate potential contamination.
Bio-Assays
One learnt of the significance and usefulness of bioassays when accessing the toxicity
of therapeutic antibodies. It is a requirement before a chemical compound receives FDA
approval that it must be thoroughly tested on laboratory cell lines before human use. For
bioassays to provide information about the activity of therapeutic antibodies cells which are
subjected to drug products are engineered to have receptors that only stimulated by these
ligands. If receptors transduce a signal the cell will elicit a detectable response which will
provide information to a user. The intensity of the signal can be varied by using various doses
of the ligand and this can provide information about the potency of a particular molecule.
Cell Culturing
The main skill that one obtained during Bio-assaying was how to correctly manage
and maintain a healthy cell line over a long period. Sub-culturing (Passaging) which is the
transfer of cells from a pre-existing vessel to another new container is needed to maintain a
large number of healthy cells. Under supervision one practiced the correct aseptic techniques

21. used for passaging cells and how to set up a fume hood to minimise contamination. One was
given the opportunity to monitor a PIG cell line by visually inspecting cells on a daily basis
with a microscope. This allowed one to acquire an ability to evaluate cell viability by
checking cell confluence and morphology.
Antibody Characterisation
One obtained a greater knowledge of antibody characterisation by shadowing a
variety of complex experiments. Analyses such as mass and florescence spectrometry allow
analysts to examine in detail the complex protein structures of antibodies for
commercialisation and investigative purposes. These characterisation techniques can be
divided into two categories: (a) primary structure characterisation and (b) biophysical
classification of secondary, tertiary and quaternary structures of antibodies. It was fascinating
seeing how state of the art confidential instruments manipulate antibodies by unfolding their
protein structure, disturbing intramolecular bonds, cleaving polysaccharide side chains and
splitting peptide grouping to decipher the composition of these intricate molecules.
Gel Electrophoresis
Gel electrophoresis analysis shadowing was one the most applicable assays in regards
to ones Genetics and Cell biology degree. One had some previous exposure to typical SDS –
Gel electrophoresis but one was delighted to oversee the use of Capillary Electrophoresis
which is steadily becoming the new industry norm. This more innovative variant of gel
electrophoresis is replacing SDS analysis because it resolves proteins more efficiently. It is
also safer and quicker than the previous method. The fundamental difference in this method
is that protein separation occurs in a narrow voltage controlled nanofluidic capillary..
QPCR
Real-Time PCR which is also known as quantitative polymerase chain reaction (qPCR) is
gene analysis technique that measures the amount DNA produced during gene amplification
.Its purpose in Eli Lilly is to detect any viral pathogens following upstream processing. This
was one of the most thought stimulating experiments in QCL as this technique featured
heavily one’s Genetics and Cell Biology degree. A clever tip that one acquired during

22. observation was contamination prevention. PCR in general is a highly sensitive technique so
maintaining sterility is a pivotal practice. By adding the constituents of the PCR test in
separate UV fume hoods one reduces the chance of contaminating
Self-Reflection
Theory -v- Practice
The skills and concepts developed in DCU during one’s Genetics and Cell Biology
(GCB) degree were advantageous in the workplace. While the degree programme is primarily
biology orientated, one discovered that the fundamental chemistry techniques that were
acquired during first year were relevant and helpful .Simple skills such as making up
solutions, ph metering and weighing accurately samples are pivotal techniques any scientist
must be able to carry out in an efficient and accurate manner. While on the surface these
techniques appear very simplistic when working in a GMP lab accuracy is essential and even
these techniques cannot be overlooked.
The latter years of one’s degree are more specialized to GCB and are principally
biology based. For this reason before starting the placement at Lilly one knew that it would
be difficult to grasp and understand the more advanced chemistry experiments. The only
experiments in Lilly Analytical QCL that overlapped with one’s degree were HPLC and GC.
These setups were central to many of the tests conducted in the Lilly QCL lab and having a
rudimentary understanding of chromatography was of an advantage. During my final weeks
of placement one encountered and shadowed more relevant experiments such as qPCR,
ELISA and large molecule production.
One thinks this particular placement would be more tailored towards a DCU
chemistry student. However while one considers that a chemistry student would be perhaps a
more suitable candidate, one firmly believes that there is no such thing as the perfect
placement. Students should be open-minded when encountering an area that may not be
totally well-matched to their degree and the onus should not be totally on the employer to
adapt work to adjust to your needs as a student. By being motivated, productive, positive and
having a general interest about your work, one can benefit a unique appreciation and insight
of entirely new areas in an industrial setting. Furthermore in an economy and environment

23. were jobs are hard sought the ability to adapt to work environments which are not suited to
you will become an ever more critical skill.
While one’s degree programme did not touch on many of the experiments carried out
in the QCL lab this has been an awarding work placement and great overall learning
experience. One has acquired an understanding of a variety of sophisticated chemistry tests
which will definitely stand to oneself going forward when pursuing a future career. It is one
thing learning about concepts in textbooks and testing your knowledge in exams but true
learning is attained by implementing models efficiently in real life practice in the lab.
Interacting with chemists who are patient and are experts in their field allowed one to acquire
new skills first hand that will no doubt complement the biology skills ascertained in
university.
Your first day on the INTRA job
One’s first day on site at Lilly comprised of several introductory talks designed to familiarize
new undergraduate starters with the general layout and safety procedures of the Kinsale site.
Whether working in a lab or walking between the buildings, safety of Eli Lilly employees is
paramount. We were shown how to respond to an accident and the correct use of a fire
extinguisher among other safety topics. The orientation was scheduled over two days and the
second day consisted of more specific safety practices and work conduct on site. Overall
one’s first days in Lilly were an enjoyable and educational experience.
Being expected to undertake a completely new area of knowledge
or a complex task
DCU’s Genetics and Cell Biology degree programme did not touch on many of the
experiments or chemistry concepts carried out in the QCL analytical. For this reason the vast
majority of the work undertaken was completely new. Approaching work in which one
doesn’t have previous experience or knowledge was a daunting task before starting in Eli
Lilly. However one is an extremely motivated individual and relishes any challenge that is
presented to them. By being enthusiastic and applying yourself to your work one was able to
overcome this information gap.

24. Finding yourself with nothing to do
A key skill that one established during work placement was becoming proactive.
While supervisors did there upmost to keep you occupied, there were times that one had
nothing to do. It’s during these periods that showing a bit of initiative and asking for more
work or carrying menial tasks is important. One quickly discovered that executing small tasks
that seem insignificant can actually be of a huge benefit. The QCL lab is an extremely busy
section of the Lilly and all analysts working very hard to meet demanding daily deadlines. By
carrying small tasks, one can alleviate some pressure from some of the analysts. It was vital
that one recognised that they were a part of a team and by doing minor tasks one can help
fellow team members work in a more efficient manner.
Realising that you have made a mistake
Perhaps the biggest learning outcome one gained working in the strict environment of
QCL is that mistakes happen no matter how careful you approach your work. The stringent
standards set out by drug authorities such as FDA are in place to ensure the safety of
pharmaceutical products. At the start one was afraid of making even the smallest mistake as
an error in documentation or deviation from procedure would let down the QCL team and
hold up work in the lab. One is a perfectionist at heart and takes tremendous pride in their
work but despite one’s best efforts mistakes were made. The best advice received while in Eli
Lilly was do not let the mistake define you instead learn from it and set the bar higher.
Admitting to a mistake and overcoming hurdles is something that one will definitely take
away from this placement and will be apply it to all areas of life.
Self-Development Plan
This Lilly placement has reinvigorated one’s enthusiasm for science. One truly
understands the role the pharmaceutical industry plays in treating illnesses. It was for this
reason why one studied science because not only does it satisfy your curiosity of how things

25. work but also it has the capacity to help improve millions of lives simultaneously. By
working in small molecule an appreciation of chemistry was gained in which one had
previously limited exposure to. One believes biopharma products are truly the future of
medicine but acknowledges that small molecule formulations will continue to play a central
role in medicinal treatments. Overall this placement has opened one’s eyes to working in the
pharmaceutical industry.
Eli Lilly promotes a balanced lifestyle and one has engaged in several social and sports
events outside the lab. One understands final year in college is of upmost significance but it is
imperative that it does not take over one’s life. By keeping fit and maintaining an active
social life the demands of final year can be reduced.
Self- Evaluation of Performance
One performed to the best of their abilities and represented DCU well. One’s
expectations of the work placement at Eli Lilly were surpassed considerably as the Internship
programme immerses students into the real inner workings of a lab. QCL was a demanding
environment to work with continuous testing and stringent documentation practices that need
to be abided by. However one feels that they carried some productive tasks that helped the
QCL team and reciprocally benefited one’s learning experience.
While one did try their best in all aspects of placement, there were areas that could
most definitely improved upon including gaining a better eye for detail when reviewing lab
practices and dealing with blunders when they sometimes occur. Ultimately this unique
experience in Cork has been a test and has allowed one to learn a lot inside and outside the
lab. One has matured as a person and feels more confident as result of working in QCL.
While this work placement was not entirely relevant to my course one made the most of it
and it has been a truly awarding experience.
Conclusion
Without a moment of hesitation one has been fortunate enough to have attained and
experienced the most sought after undergraduate scientific internships in Ireland. Upon

26. reflection one feels lucky to have been able to take their first steps in their science career in
one of the biggest pharmaceutical companies in the world. Ultimately one would highly
recommend Eli Lilly’s undergraduate internship to any DCU student. The pleasant and
relaxing atmosphere in Eli Lilly allows students to smoothly transition from college lecture
hall to analytical laboratory. During the six months in Eli Lilly one has truthfully experienced
the inner workings of huge pharmaceutical company from how pharmaceutical drugs are
produced in large scale, tested in accordance to FDA guidelines and marketed across the
globe.
One received a great deal of training on safety practices, experimental analysis and
employee conduct which gave assurance when completing tasks in areas not encountered
before. This placement immerses students in the day to day running of QCL and permits
students to get involved in a variety of desktop and lab bench projects that can be only
experienced in an industrial setting. This internship has allowed one to attain a wealth of
practical and theoretical scientific knowledge that will compliment one’s biology degree and
will no doubt be of enormous benefit when conducting analysis and seeking future
employment.
One now recognizes to be a good scientist not only takes proficient laboratory skills
but also social skills. From approachable team leaders to patient analysts the entire staff strive
to ensure each student has an enjoyable educational experience by offering advice on lab
projects and personal challenges in industry. In addition the opportunity to share your
internship experience with 20 other undergraduate students from a range of disciplines was
an unparalleled experience. This allowed one to learn from each other’s involvements, share
everyday experiences and partake in countless social activities outside work. Having a
miniature student community within Eli Lilly allowed one to mingle with people from
colleges all over Ireland and ultimately this contributed to a desired balanced lifestyle after
working hours. During one’s six month placement friendships have been forged that will
extend for a long time after internship.
In conclusion in Eli Lilly employees and students work hand in hand with the
common to purpose of manufacturing drugs that help people. This ethos of helping people is
the cornerstone of the work conducted in Eli Lilly and one’s passion in life. Science
especially pharmaceutical science affords individuals the opportunity to improve the quality

27. of health of millions of patients by producing safe and quality products. Not only has this
internship been a defining educational and social experience but one senses for the first time
they contributed to a process that endeavours to save lives.