Sartorius Stedim Cellca. Custom Cell Line & Process Development for Pharmaceutical Purposes

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1 Sartorius Stedim Cellca Custom Cell Line & Process Development for Pharmaceutical Purposes May 2017

2 Overview of Contents Cellca History Overview: Cellca Technology Platform Products & Services 4 Key Parameters: Why Cellca? 5 Contact Information 2

3 Cellca History Founded by Dr. Cayli Focus: R&D, integrate molecular & cellular biology with process knowhow Product Development Building Infrastructure First technology transfer Growing the company & customer base Completed 48 projects 2015 Improving the platform & performance Growing internationally as a part of Sartorius group 3

4 Overview: Cellca Technology Platform Cellca CMO/Client Cell Line Development Process Development Process Transfer GMP Production Downstream Processing Fill & Finish Host cell line Expression Vector Media System Upstream Process Design Host Cell Line: CHO DG44 growth in suspension, 18 h doubling time, long term stability Expression Vector: DHFR selection system, low DHFR expression, S/MAR elements, optimal signal peptide Media System: Optimized, chemically defined, free of animal components, proteins & peptones, high cell densities, viabilities & productivity Upstream Process Design: robust, easy to scale, proven performance in various bioreactor systems 4

5 Products & Services FEE FOR SERVICE Our service is divided into individual work packages starting from DNA synthesis to RCB generation, stability studies, or process confirmation in lab-scale bioreactors. TECHNOLOGY PLATFORM LICENSING Technology transfer to enable in-house generation of high producing cell lines MEDIA SUPPLY All parts of the media system are completely chemically defined and optimized for the different stages. They are commercially available. 5

6 Key Parameters: Why Cellca? Speed Track Record Scalability Performance Customer Focus 6

7 Speed From DNA to RCB within 4-5 months. No need for media and process development. Save up to 3 months by omitting scalability studies! Vector Cloning Transfection and Pool Generation Single Cell Cloning Clone Evaluation RCB Preparation From DNA to RCB in 4 to 5 months 7

8 Scalability Cellca technology platform was developed from scratch specifically for the industrial production Focused development at Cellca lead to a process providing: Direct and robust scale-up to production scale No need for scalability studies 8

9 Viable Cell Conc. [ 10 5 /ml ] Viability [%] Product conc. [ g/l ] Scalability Comparison VCC, Viability, Product conc mL, 5-L & 1000-L Time [ d ] SF 25-mL VCC BIR 5-L VCC SUB 1000-L VCC Xcellerex VCC SF 25-mL Viability BIR 5-L Viability SUB 1000-L Viability Xcellerex Viability SF 25-mL Product BIR 5-L Product SUB 1000-L Viability Xcellerex Product

10 Performance: Titer Efficient cost reduction by achieving steadily productivities of 3g/L or more Cost reduced by 50% by omitting media and process optimization Cost of Goods /g Clone distribution Cellca* 95%; 3 g/l

11 Performance: Quality Targeted modification of quality attributes (e.g. glycosylation pattern) Application for biosimilars Scalability of modifications 11

12 Track Record Cellca Track Record (March 2016) 2 g/l 3 g/l 4 g/l 5 g/l 6 g/l Pre-clinic & Phase Phase Phase Market Approval >40 cell lines built to date Small, Medium and Big Pharma US, EU, Asia Customers 60% returning customers 95% express 3 g/l or more Monoclonal Antibodies (IgG1, IgG4, IgG2) Fusion Proteins Fab-related products Bispecifics Biosimilars Applications: NBE Biosimilar projects Replacement E. coli Productivity Improvement 12

13 Customer Focus PROPOSAL: Direct service and support by Product Management Team: Adelheid Burkhardt Dr. Lucia Rieger Kick Off Data Packages Regular TCs Scope changes possible PROJECT: Committed project team & close contact with Customer Order Manager: Renate Westner Alexander Pietschmann Heike Mayer (Head of Team) Final report Detailed Discussions F2F, TCs Agreement by both sides Final proposal SLA 13

14 Benefits of Cellca Technology Platform SPEED From DNA to high-titre RCB in 4-6 months. Save up to 3 months by omitting the need for scalability studies. SCALABILITY Processes can be easily transferred and scaled-up to a range of bioreactors up to 1000L. PERFORMANCE 95 % of our developed cell lines deliver protein titres exceeding 3 g/l in a day standard fed-batch process. TRACK RECORD More than 40 successfully completed projects using the Cellca CHO Expression Platform. CUSTOMER FOCUS Committed project teams and dedicated client manager s make it their purpose to deliver service excellence and meet our clients requirements.

15 For more information on Sartorius Stedim Cellca s Cell Line Development services: Contact us at