Optimization Strategies of Expression Cell Line Construction to Reduce the Biological Drug Development Risk. Feng Gao, MD, PhD. AutekBio CO.

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1 Optimization Strategies of Expression Cell Line Construction to Reduce the Biological Drug Development Risk Feng Gao, MD, PhD AutekBio CO.

2 Expression Systems used for Approved Antibody and Antibody-Related Drug CHO Mouse Myeloma (Sp2/0, NS0) Hybridoma E. Coli ~ 72% well characterized continuous cell line- rodent origin 50% CHO/ 50% mouse myeloma ~ 19% hydridoma ~ 8% bacterial Drug Information Association 2

3 Phase Length of FDA Approved Products Drug Information Association 3

4 Monoclonal Antibody New Drug Development & Production Process Progression MAb Selection Initial Tests GLP Study IND Phase I/II Phase III NDA Commercial Production mg 1-10g 10-50g g kilograms Requirements Research R&D GMP FDA cgmp FDA inspected cgmp, no process change Equipments Normal Lab <50L <250L Bioreactor Bioreactor <1000L Bioreactor 3,000-20,000L Bioreactor, multiple lines Cell Line Generation (CLG) Process Development & Scaling-up GMP Production

5 Current Improvement in Cell Development Transient expression in bioreactor Provide gram level products at early stage Higher titer and yield Good enough cell line and process in short time Faster development timeline Shorten timeline to clinical trial Single-used bioreactor Increase flexibility of DS and DP production Drug Information Association 5

6 Different Strategies to Speed-up Drug Development Timeline IND NDA CLG & PD Pre-clinical Studies Phase I & II Clinical Trial Phase III Clinical Trial On Market Typical Approach Cell Line Generation (5-12M) Process Development (>12M) grams Scale-up (10M) grams Scale-up (12M) grams Scale-up years Cur. Approach International Preliminary CLG & Process Development (12M) grams Scale-up (10M) grams Cell Line Generation & Process Development (12M) grams Scale-up years Available Approach International Large-scale transient expression (3-6M) grams Preliminary CLG & PD (12M) grams Cell Line Generation & Process Development (12M) grams Scale-up years Drug Information Association 6

7 Selection of Candidate IND Pre-clinical Study Phase I/II Phase III NDA Cell Development and DS Production GMP DP Manufacturing GMP DP Manufacturing Scale-up PD for Market Production Selection of Candidate IND Pre-clinical Study Phase I/II Phase III NDA Good Cell Development and DS Production Good Cell Production Final Manufacturing Cell Development and GMP DP Manufacturing Scale-up PD for Market Production Selection of Candidate IND Pre-clinical Study Phase I/II Phase III NDA Transient DS Production Good Cell Development and DS Production Final Cell Development & GMP DP Manufacturing Scale-up PD for Market Production Drug Information Association 7

8 What is available in China and how can we implement the new technologies in drug development? Drug Information Association 8

9 Using Transient Expression for Material Production in Early Stage Protein Production Using Transient Methods Time 7-10 days; Host cells CHO, HEK 293 Medium Serum free, ACF MAb 1 ~500 mg/l Other low expression recombinant protein Up to 20 mg/l Drug Information Association 9

10 Large-scale Transient Expression Gram level mab production in short time Good for candidate screening and selection Preliminary PK/PD study Toxicity prediction Drug Information Association 10

11 Sample data: Delivered Good Cell Lines for mab Production Drug Information Association 11

12 Good Cell Line and Process for Material Preparation Tens of grams production starts in 6 months after good cell line generation and good process development Ready for preliminary animal studies Products close to final target protein drug Ready for formulation study Ready for analytical method development Drug Information Association 12

13 Process development, DOE strategy Simplex Lattice Design to Optimize Basal Medium Drug Information Association 13

14 Process development, DOE strategy continued Response Surface Design to Optimize Feed Supplement Drug Information Association 14

15 Process development, DOE strategy continued Drug Information Association 15

16 In-depth Studies for Final Manufacturing Cell Line and Process MCB ready Scalable process ready Half Kg production Ready for pre-clinical study Drug Information Association 16

17 Scaling-Up Using Single-Use Bioreactor 50L S.U.B. 250L S.U.B. Drug Information Association 17

18 Single-used Bioreactor To save space and initial investment Gives flexibility on process development and material production Short turn-around time for multiple products Drug Information Association 18

19 Fully integrated DSP capability scales from mg to kg Drug Information Association 19

20 Summary New technologies provide more options for drug development strategy To choose different strategy Different application system and different application approaches The characteristics of the target protein The availability of analytical technology Cost and timeline Drug Information Association 20

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