Presented by: Dayn Sommer, Ph.D. at WCBP 2020

2. Data Collection on the ProteinSimple Maurice:
Driving Compliance with the Empower Control Kit
Dayn Sommer, KBI Biopharma
28 Jan 2020
WCBP 2020

3. KBI Biopharma Overview
ProteinSimple Maurice
Empower® Control Kit
Example Data

4. CONFIDENTIAL | 4
Analytical Services
All Sites
MORE HIGHLIGHTS
Industry leading array of analytical equipment
and scientific expertise
150+ Formulation development projects to date
Multiple dosage forms: Intravenous,
Subcutaneous, Intramuscular Intravitreal, Topicals
Product concentrations ranging from 10 µg/mL to
300 mg/mL
200+ active product stability studies
(GMP & non-GMP)
KBI Is The Industry-Leader In
Protein Analytics
3000+
Projects Completed
15 years
Of Leadership in
Formulation Development
PERFORMANCE
Experience Across
all Biologics
• IgG1
• IgG2
• IgG4
• Bispecific
• IgM
• Fab
• ADC
• Fc and other
Fusion Proteins
• Enzymes
• Cytokines
• Growth factors
• Highly Glycosylated
Proteins
• Protein vaccines
• PEGylated proteins
• Conjugates
• Peptides
• Polyclonals
• Biosimilars

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COLORADO
BOULDER, CO
Microbial
LOUISVILLE, CO
Analytics
Strain Development
Process & Analytical Development
cGMP Manufacturing and QC Services
Analytical, Formulation, Stability
Particle Characterization Core
Modeling and Simulation
Analytical Technologies
Leading Biophysical Characterization
NORTH CAROLINA
DURHAM, NC
Mammalian
RTP, NC
Mammalian
Clinical & Commercial cGMP Manufacturing
Analytical, Formulation, Stability & QC
Mass Spec Core Facility
Cell Line Dev- Offering SureTechnology
Process & Analytical Development
Process Characterization
Small scale Process Validation
TEXAS
WOODLANDS, TX
Cell Therapy
Process and Analytical Development
cGMP Manufacturing & Testing
Cell Based Assays
CALIFORNIA
SAN DIEGO, CA
Analytics
Analytical Technologies
Leading AUC expertise
EUROPE
GENEVA, SWITZERLAND
KBI-affiliate Selexis
LEUVEN, BELGIUM
Analytics
Best in class cell line development &
variant screening technologies
Analytical, Formulation and QC services for
GMP & non-GMP product testing

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Quality & Regulatory
All Sites
Successfully Completed
4 FDA Inspections
No 483 observations.
Includes two pre-approval
inspections.
Successfully Completed
COFEPRIS Inspection
North Carolina Site
PERFORMANCE
15 years of pressure-tested
quality systems & rigorous
regulatory compliance.
Global cGMP quality system supporting
clinical and commercial biologics
Manufactured and released hundreds of
cGMP product lots
Successfully
Completed
2 EMA Inspections
Boulder Site
Supports 2 Commercial
Products
Analytical Testing
Successfully Completed
2 FDA PAIs
Successfully
Completed
EMA Inspection
Product Approved in
US and EU in 2018

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Meet Maurice

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Maurice –”moreiCE”
2016
CE – SDS,
Native Fluorescence,
On-board Mixing,
Proprietary cartridges,
…….

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Maurice cIEF Cartridge

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Maurice CE-SDS Cartridge

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Consistency in Structure Across Assays
cIEF
CE-SDS
the Cartridge
determines
the run modus:
cIEF
or
CE-SDS

12. Compass by ProteinSimple Empower® 3 by Waters™
• Out-of-the-box software
package for data acquisition
through processing.
• Fully 21 CFR Part 11
compliant:
• Audit trail, system validations,
and controlled access.
• Transfer of data from Compass
must be governed by internal
procedures, including securing
paths/locations
• Export of data can result in loss
of metadata
• Enterprise software package for
data acquisition, analysis, and
storage.
• Automated data analysis can be
enabled to simplify QC testing.
• Well-established in industry:
• Validated in most companies
• Extensive knowledge base and
training solutions
• Reduced software maintenance (IT,
metrology) and streamlined data
review

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Sample plate layout
(48 vial or 96-well plate)
Create Method
Input sample ID,
location, and method
Temperature Control
cIEF Reagents
Tabs

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Peaks pane shows calculated results. Compass
for iCE names automatically with user-defined
peak name settings are color-coded
pI markers Samples Single/ Total Sample View
Peak Profiles
Injection
info
E-gram options
Injections tab provides peak area
analysis
pI
marker
pI
marker

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Autosampler temperature can be modified Cartridge information displayed

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icIEF – pI Marker Calibration (Linear Regression)
• The Empower® software will calibrate pI based on detection of pI marker position
settings.
• This calibration cannot be reperformed once data is collected.
• Solutions
• Adjust pI marker position and window size
• Perform test injection of reference standard to determine pI marker pixel position
• Excel
• Create custom fields in empower to calculate pI values

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• Component editor to assign
values for designated pI
markers
• Integrate and identify
component markers

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• Calculate pI of unknowns
with custom fields

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CE-SDS – Corrected Area
• Results are not only a function of concentration but also of analyte velocity through the
detection window. Peak areas need to be normalized based on velocity.
• Create corrected area calculations in empower to account for differences in apparent velocities
between solutes:

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CE-SDS – Corrected Area
• Results are not only a function of concentration but also of analyte velocity through the
detection window. Peak areas need to be normalized based on velocity.
• Create corrected area calculations in empower to account for differences in apparent velocities
between solutes:
CE-SDS – MW Sizing
• Empower will not determine sizing data automatically
• Use custom fields to extrapolate sizing data if necessary

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• Maurice is an efficient tool to analyze charge heterogeneity, determine
pI, purity, and size of biomolecules
• Updates from Protein Simple have allowed Maurice analysis with
Empower® Software

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• Maurice is an efficient tool to analyze charge heterogeneity, determine
pI, purity, and size of biomolecules
• Updates from Protein Simple have allowed Maurice analysis with
Empower® Software
• Maurice Empower® Control Software has been released!

38. CONFIDENTIAL | 38
Protein Simple
Jessica Dermody
Rick Le Bold
Xin Jiang
KBI Biopharma
Charlie Abadie
Christopher Cox
Nathan Cox
Michael Alloway
Ben Pridgen

39. Dayn Sommer
dsommer@kbibiopharma.comGuided by analytics,
we help our partners develop and
manufacture life-changing biologics.
kbibiopharma.com
@kbibiopharma