Recombinant Antibody Production in Therapeutic Antibody Projects. Keshav Vasanthavada Senior Marketing Specialist, GenScript April 7, 2016

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1 Recombinant Antibody Production in Therapeutic Antibody Projects Keshav Vasanthavada Senior Marketing Specialist, GenScript April 7, 2016

2 Presentation Outline Introduction Recombinant Ab Production GenScript Capabilities & Services Case Studies Summary & Conclusion Make Research Easy 2

3 Introduction Make Research Easy 3

4 About GenScript Gene Cell Line Peptide Discovery Biology GenScript Products & Services Make Research Easy Protein Antibody Make Research Easy Introduction 4

5 Expression Systems Introduction Make Research Easy 5

6 Production Track Record Track Record >6000 batches of high quality protein >1500 batches of high quality rabs >92% success rate for all projects Successfully delivered a variety of protein targets We deliver guaranteed and fully customizable, high quality recombinant antibody and protein services with fast turnaround timelines and at very competitive prices Introduction Make Research Easy 6

7 GenScript Ab Drug Discovery Services Introduction Make Research Easy 7

8 Recombinant Ab (rab) Production Make Research Easy 8

9 Why rabs? Traditional mab technology first developed in 1975 by Kӧhler and Milstein. Mature technology, very robust and cost-effective. Issues include Ethical concerns Non-specificity Instability of hybridomas causing loss of Ab genes Potential immunogenicity (HAMA response) Irreproducibility Series of Nature articles reported on the reproducibility crisis in biomedical sciences caused by Abs. Nearly $350M/year wasted on irreproducible Abs. Scientists at leading organizations including >100 co-signatories proposed shifting entirely towards rabs. Recombinant Ab Production Make Research Easy 9

10 Advantages of rabs Non-animal technology More control over the process Speed production time in weeks HTP processing Can be constructed against virtually any antigen Immunogenicity not an issue rabs can be produced in several formats: Fabs, scfv, diabodies Amenable to fusion with drugs and toxins Sequence-defined making them more reliable and reproducible Conducive to optimization and engineering There are various ways in which a researcher can utilize rab technology rab technology is not intended to entirely replace conventional technologies. In most cases rab technology supplements existing technologies. Recombinant Ab Production Make Research Easy 10

11 Entry Point into rab Production Display Transgenic Animal Hybridoma rab Production Other Recombinant Ab Production Make Research Easy 11

12 GenScript Capabilities & Services Make Research Easy 12

13 Options for rab Production Transient Expression 50ug to gram-level expression Rapid - as early as 6 weeks Starting from $499 Production Technologies Stable Cell Pool 300mg to gram-level expression As early as 8 weeks Competitive pricing Stable Clonal Cell Line Multiple gram-level expression Between weeks Suitable for large scale consistent production of your rab GenScript Capabilities & Services Make Research Easy 13

14 Transient Expression Licensed NRC Technologies Licensed from NRC, Canada HEK293 Highly stable 293EBNA1 clone. Afford the advantages of serum-free production. Rapid and high yield recombinant production. CHO-pTT Provides comparable protein expression level to those of HEK293 system. Rapid production of recombinant proteins that require post-translation modification for research or pharmaceutical use. GenScript Capabilities & Services Make Research Easy 14

15 Stable Cell Pool Use of GenScript Technology results in high-producing cell pools. Cell pools achieved within 8 weeks GenScript Capabilities & Services Make Research Easy 15

16 Titer (g/l) GenScript CHO-GS Stable Cell Line GS GS based selection system High productivities without amplification Speed no need for rounds of gene amplification Scalable CHO CHO derived host cell line for expression Adapted to suspension and AFCDM Selected for superior growth and expression Cell Line Development Fully optimized process Product concentrations of >5g/L achieved High probability of monoclonality 6 4 mab Expression level High volumetric productivity 2 0 Pool Single cell clone Batch culture Fed-batch round 1 Fed-batch round 2 Cost mab Expression level GenScript has created cell lines producing >5g/L of recombinant antibody with production rates in the range pg/cell/day. GenScript Capabilities & Services Make Research Easy 16

17 General Schematic of rab Production GenScript Capabilities & Services Make Research Easy 17

18 Industry Pipeline Discovery Preclinical Development GLP Workup GMP Workup Target Validation Screening Preparation Lead Generation Lead Optimization & Characterization Lead Selection No. Examples 1 HTP expression and purification of recombinant proteins & antibodies: Quantity: 1-5ml, purification: 96 well plates Protein A column 2 Lab scale transient expression in shaking flasks (100ml-10L): Transient expression in mammalian cells, mostly HEK293 3 Mid scale expression in wave bags (10L-25L): Transient (HEK293) or Stable pool production (CHO cells) 4 5 Large scale wave bags or bioreactor (varies): Transient or Stable pool production (CHO cells, >25L), or Stable cell line production (CHO-GS, >10L, deliver cell line) Characterization services with LC-MS as the core technology: Critical for verification and the release of bio products, more important in the latter stage of R&D, absolutely required in clinical stage GenScript Capabilities & Services Make Research Easy 18

19 rab Service Guide With solid expertise in recombinant antibody (rab) production techniques, GenScript provides a comprehensive rab service portfolio. Choose from services that deliver microgram to gram quantities of pure rab for each stage of your Ab drug discovery program Purpose Screening Candidate validation In vitro efficacy In vivo efficacy Safety test with GLP *Not including gene synthesis # Including gene synthesis Service HTP Gene to Antibody Production MamPower guaranteed recombinant antibody production MamPower guaranteed recombinant antibody production Large scale recombinant antibody production Large scale recombinant antibody production Custom Services Custom Services Production Type HTP Transient Expression Transient Expression in Shaking flask Transient Expression in Shaking flask Transient Expression in Wavebag Volume Wavebag cell 10L-25L pool Bioreactor cell 25L-100L pool Gram Level Bioreactor cell Bioproduction cell line 10L-100L line service Antibody quantity Timeline Guiding Price per unit QC standard 1ml-5ml 40μg-200μg 2-3 weeks ~$300 per variant* Titer: ELISA Purity: SDS-PAGE -85% Quantitation: UV A280 Titer: ELISA 0.1L-1L 4mg-100mg 3-4 weeks $30-$500/mg antibody # Purity: SDS-PAGE -90% Quantitation: UV A280 1L-10L 40mg-1g 4-5 weeks $12-75/mg antibody # 10L-25L 400mg-2.5g 6-8 weeks $10-30/mg antibody # 1g-12.5g 2.5g-50g 10g-100g weeks weeks Titer: ELISA Purity: SDS-PAGE -95%; HPLC -95% Quantitation: UV A280 Endotoxin:<1EU/mg Titer: ELISA Purity: SDS-PAGE -95%/99%; HPLC -95%/99% Quantitation: UV A280 $3.2-22/mg antibody # Endotoxin:<1EU/mg or <0.1EU/mg $2.4-16/mg antibody # Titer: ELISA Purity: SDS-PAGE -95%/99%; HPLC -95%/99% Quantitation: UV A280 $1.5-6/mg antibody # Endotoxin:<1EU/mg or <0.1EU/mg Identification: MS Make Research Easy weeks GenScript Capabilities & Services

20 MamPower Guaranteed Services Customer provides Amount Purity & endotoxin level options Timeline Deliverables Price starting from Antibody sequence 5mg 95% by SDS-PAGE 5-6 weeks 10mg 25mg 50mg 100mg 250mg 500mg 95% by SDS-PAGE Endotoxin 10EU/mg Concentration 1mg/ml 95% by HPLC Endotoxin 1EU/mg 6-8 weeks 8-10 weeks LC and HC in puc57 vector Optimized gene sequence report Purified antibody at listed amount and purity QC data $2,999 Key features of MamPower guaranteed recombinant antibody production services Gene synthesis is included in the package no additional cost to you. Guarantee recombinant antibody amount, purity and endotoxin control no cost to you if we don't deliver as promised. Flexible scale from 5mg to 500mg. Competitive price. Fast turnaround time - as little as 5 weeks. Make Research Easy GenScript Capabilities & Services 20

21 HTP Gene to Antibody Service Workflow Ideal for Antibody Screening and Optimization Campaigns Minimum 24 Abs required 50ug or 1mg packages 6-8 weeks Starting at $499/Ab (including gene synthesis) GenScript Capabilities & Services Make Research Easy 21

22 Case Studies Make Research Easy 22

23 Case Study 1: Low Expression Expression level was low (2.5 mg/l) Optimized Antibody Sequence OptimumGene TM Codon Optimization Optimized Transfection and Purification Expression level was significantly increased (25 mg/l) Make Research Easy Case Studies 23

24 Case Study 2: No Expression Target: Antibody 1 (MW ~ 150 kda) Western blot Western blot Fig.1. SDS-PAGE and Western blot analysis of Antibody 1 Lane M: Marker Lane 1~3: Cell culture supernatant from day 2, 4 and 6 post-transfection R (293) Lane 4~6: Cell culture supernatant from day 2, 4 and 6 post-transfection R(CHO) Lane 7~9: Cell culture supernatant from day 2, 4 and 6 post-transfection N (293) Lane 10~12: Cell culture supernatant from day 2, 4 and 6 post-transfection N (CHO) Lane P: Mouse IgG1, Kappa (Sigma, Cat.No.M9269) as positive control The target Antibody has no expression (left panel) Upon sequence revision, the expression level of target antibody reached ~15 mg/l. Case Studies Make Research Easy 24

25 Case Study 3: Client HTP Ab Production Client has access to a proprietary technology for identifying and isolating antigen-specific B-cells. Using a group of patients [4, healthy immunocompetent] who contracted and cleared HIV infection: Identified B-cells specific for the desired epitope Isolated and sequenced the unique antibody sequences Cloned, purified and confirmed reactivity of antibodies Engaged GenScript to continue pre-clinical development of a panel of positive Abs. Client focused on biology and developability of lead Abs to ensure efficacy while minimizing downstream risks. Case Studies Make Research Easy 25

26 Case Study 3 Specifics Screening & Candidate Validation Biotech Client 4, patient-derived anti-hiv neutralizing Abs Customer in-silico optimized sequences for production and development of Abs HTP GtA, 1mg HTP Biophysical Characterization [thermal stability, aggregation propensity] MamPower TM and customized rab services Few 100 mgs for: Viscosity screening Colloidal stability Solubility Stability Screening assay Filterability Finally 3-10 Abs Identify that are active and with desirable biophysical properties Case Studies Make Research Easy 26

27 Case Study 3 Specifics In vitro & In vivo efficacy & Safety Few 100mgs required for: MamPower TM, Large scale rab In vitro neutralization assays [current strategies to measure the neutralization activity of anti-hiv-1 mabs involve wellestablished TZM-bl cell-based assays] Few grams required for: Large scale rab, Custom services cell pool In vivo protective activity of anti-hiv-1 Ab in mouse and macaques Safety test Cell pool, Cell line Case Studies Make Research Easy 27

28 Summary & Conclusion Make Research Easy 28

29 GenScript Capability >1500 batches of high quality rabs BiScFv C-Fc tag protein N-Fc tag protein VL V H ScFv1 Linker ScFv2 V H VL His Summary & Conclusion Make Research Easy 29

30 Quotations & Ordering Workflow Summary & Conclusion Make Research Easy 30

31 Why Choose GenScript Summary & Conclusion Make Research Easy 31

32 Antibody Handbook Topics include Antibody structure, isotypes and formats Antibody fragments and advantages Antibody drug discovery process Humanization and Affinity maturation rab Production rab purification and characterization and more Summary & Conclusion Make Research Easy 32

33 Upcoming Webinars To register for other webinars in the GenScript Webinar Series visit April 12, 2016 / 2:00 PM EST Genetic variants: tips & techniques for creating novel synthetic genes Laura Geuss, Ph.D. April 21, 2016 / 9:00 AM EST Anti-idiotype antibody generation and application in antibody drug discovery - Liusong Yin, Ph.D. April 28, 2016/ 9:00 AM EST CRISPR grna libraries: design options, applications, and how they can accelerate your genetic screening studies Peter Dai, Ph.D. May 10, 2016 / 9:00 AM EST Antibody generation: challenges and solutions Glen Marszalowicz, Ph.D. May 18, 2016/ 9:00 AM EST Recombinant protein production in baculovirus/insect expression system Yong Liu, Ph.D. keshav.vasanthavada@genscript.com Summary & Conclusion Make Research Easy 33

34 Thank You! Make Research Easy 34

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