Founded in 1980, Kemwell provides customized process/product development and manufacturing to biopharmaceutical organizations worldwide. Our facilities are located in Bangalore, India and were built with technical guidance from Boehringer Ingelheim, providing customers with state-of-the-art technology along with the benefit of cost-effective manufacturing. The 15,000 sq. m. facility consist of a cGMP drug substance manufacturing facility with 2x2000L bioreactors and a sterile fill and finish facility for cGMP drug product manufacturing with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation. For over 30 years, Kemwell supported pharmaceutical companies with their development and manufacturing needs. We developed and manufactured drugs for some of the world’s top pharmaceutical companies including Bayer, GlaxoSmithKline, Merck KGaA, Novartis and Pfizer. In 2017, Kemwell sold its pharmaceutical business to Recipharm AB but continues to leverage its 30-year experience to provide biotech customers with cost-effective solutions.

1. 1Confidential
BIOPHARMACEUTICAL CAPABILITIES
July 2014
BIOPHARMACEUTICAL CAPABILITIES
August 2014
Biologics Contract Development and Manufacturing
(CDMO) Capabilities

2. A Reliable, Flexible, Cost Effective Partner for your
Contract Development and Manufacturing Requirements
 GMP Mammalian cell culture
- Drug Substance – 80 to 2000L
- Drug Product – Lyo and Liquid Vials
 State-of-the-art facility meeting FDA,
EMA regulations
 150 employees across PD, QC, QA,
Manufacturing
 Flexible to support quick turnarounds
and increase speed to clinic
 Experience in supplying and
supporting US IND trials (including
Phase III supply in 2018)
 Cost effective development & lower
COGS
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3. Cell line
development
(outsourced to a
Partner & managed
by Kemwell)
Process
Development
Upstream and
Downstream
Analytical and
Formulation
Development incl.
Stability Studies
Scale up and
Clinical
Manufacturing of
Drug Substance
and Drug Product
Commercial
Manufacturing of
Drug Substance
and Drug Product
Integrated CMC Development for your Product
3
GMP Drug Substance Capacity GMP Drug Product Capacity
400L Bioreactor Liquid Vials 2ml – 50ml
2 x 2000L Bioreactors Lyo Vials 2ml – 50ml
Batch Size: 300L Bulk

4. Experienced Management Team and Advisors
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Anurag Bagaria, Chairman and CEO
- Over 15 Years of Experience, second generation entrepreneur
- Pharma business built to 100+ Million USD
- MBA from Kellogg Business School and BS in Chemical Engineering, Cornell University
Jaby Jacob, AVP Process Development
- 20+ Years of Experience in USA and India
- Previous experience include Amgen, Dr. Reddy’s
- PhD from Indian Institute of Science and Post-Doc from University of Chicago
Sanjay Lodha, AVP Operations
- Over 23 Years of Experience in Biologics Manufacturing
- Senior positions at Glenmark, Dr. Reddy’s and Zenotech
- Masters in Biochemical Engineering from IIT, Delhi
Prof. Dr. Dr. Rolf Werner, Advisory and Board Member
- Over 35 Years of Experience in biotech industry
- Previously held senior positions (Corp Sr VP) at Boehringer Ingelheim
- Professor at University of Tubingen, Germany
Shabbir Anik, Advisory Board
- Over 35 Years of Experience
- CDMO experience at Patheon (Head of Development) and Althea (CEO)
- Senior positions at Amgen/Onyx, Sutrobio

5. 1980
Founded by
Subhash Bagaria
1980-2006
Grew as a CMO for
pharmaceuticals
serving the Indian
market
2006 -2015
Grew as a global CDMO
adding sites in Europe,
USA for manufacturing
and development. Sales
of 100+ million USD
serving 100+ Customers
2015
Built and operating
India’s largest biologics
CMO plant with GMP
certification
2016
Sold global Pharma
business to
Recipharm
2017 -
Present
Clinical Supply of
mAbs for USFDA
approved Trials
Glaxo was our first
client in 1980,
largest client till
2017
80, 400, 2 x 2000 L cell culture
manufacturing capacity
Kemwell to focus on
Biologics CDMO
business
Kemwell : An established CMO for 30+ Years

6. Technical Capabilities and Experience

7. Upstream Process Development
 DoE based approach for screening 30 different process conditions
 5 – 10L development scale; 80L scale-up model
 Batch success rate > 95%
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8. Downstream Process Development
 Downstream processes developed and
scaled up for multiple mAbs (biosimilars
and NBE)
- Protein A, CEX, AEX and UF/DF process steps
 Define critical and key process
parameters; DoE based studies to
confirm robustness
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9.  Well equipped analytical development lab (HPLC, UPLC, CE, Plate reader,
spectrophotometer, etc.)
 Completed analytical methods transfer and validation for multiple projects
 Procedures in place to track performance of analytical methods
 Developed and optimized lyophilisation cycles
 Formulation development at ~125 mg/ml in pre-filled syringes
 Stability studies for DS and DP, performed under different conditions (2-8oC,
25oC/60% RH, 40oC/75% RH, -80oC and -20oC).
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Formulation, Analytical Development and Stability Studies

10. Analytical Capabilities
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Any outsourced tests (Biacore, MS, biophysical
characterization) would be managed by Kemwell.

11. GMP Drug Substance Manufacturing
 Clinical trial material supplied for trials in
US and ROW
 Upstream - Bioreactor train of 80L 
400L  2x2000 L stainless steel
bioreactors
 Harvest - Continuous centrifugation
and/or lenticular filtration
 Downstream - Multiple chromatography
and TFF steps; pre and post-viral
segregation
 Designed for purifying high titer cultures
 BI-Sartorius multi-product designed
facility
 Data acquisition system with 21 CFR part
11 compliance
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12.  Supplying commercial mAb drug product for
ROW markets (customers include US and
Indian MNCs)
 Sterile dosage forms capabilities:
- Liquid and lyophilized vials
- Vial sizes from 2ml to 50ml
 Integrated vial filling line from Bausch+Ströbel
 Lyophilizer: 80 sq.ft. shelf area with automatic
CIP and SIP facility
 Pre-filled syringes (future possibility)
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GMP Drug Product Manufacturing
Liquid Vial Capacity
Vial Size
(ml)
Max. Batch Size (vials)
2 42,000*
5 33,600*
10 30,000
20 15,000
50 6,000
Lyophilized Vials Capacity
Vial Size
(ml)
Max. Batch Size
(vials)
2 29,000
5 15,000
10 13,000
20 8,000
50 4,000
*1-shift operation
Maximum batch size: 300L (Formulated bulk)

13. Customer Projects - Accomplishments
 Technology transfer from customer
lab in Europe to Kemwell,
Bangalore was completed
successfully in 4 months
 Improved upstream productivity by
20%
 Optimized lab-scale process for
large scale production
 Lyo process duration was reduced
by 50%
 Transferred completed development
reports for successful US IND filing
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14. Case Study: Tech Transfer to Phase III
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Technology
Transfer
4 months
Process
Optimization &
Method
Validation
4 Months
Phase-I
Manufacturing
Campaign at
400L
5 Months
Biosimilarity
Analysis 2 Months
Process
Optimization 4 Months
Phase-III
Manufacturing
Campaign at
2000L
5 Months
Kemwell’s dedicated Project Management
teams in Bangalore and Boston ensure
efficient and timely delivery of projects

15. Building Strategic Customer Relationships
 Flexible business models
- Traditional Fee For Service
- Risk Sharing Approaches; Reduced Upfront Fees; Share Downstream Success
through milestone
 Strategic Long-term Partnerships
- Ability to build and run large scale manufacturing plants
- Build new capabilities in R&D and manufacturing
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16. www.kemwellbiopharma.com | www. cirruspharm.com
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www.kemwellbiopharma.com