Yanhuai (Richard) Ding

Anaptysbio, Inc.

Richard (Yanhuai) Ding, Ph.D. Work: 8508 Flanders Drive, San Diego, CA92126 Home: 6203 Schindler Drive S, Monmouth Junction, NJ08852 Phone: 413-687-1061(cell) U.S Citizen, yrding@gmail.com SUMMARY With over 20 years’ work experience including protein purification, process development, technology transfer, scaled-up/scaled-down, process validation, viral clearance, IND/BLA filing support, commercial production trouble-shooting; developed many innovative, robust, efficient, cost effective, and scalable processes with proven success record from large molecules (biosimilars, mAbs, bispecific, Fc-fusion proteins, enzymes, vaccines from bench to commercialization (from microbial fermentation to mammalian cell culture based); with managerial experience (project planning, proposal preparation and review, tech report preparation, managing and mentoring people), regulatory filing, and oral presentation in national and international conferences. • Strong technical expertise in downstream process development (chromatography, membrane based separation, TFF, viral clearance, tech transfer…) from bench to cGMP manufacturing • Rich experience of managing a downstream PD, MSAT and MFG teams for multi-project development scale-up, manufacturing support, and commercial production trouble-shooting. • Strong technical and strategic contributions to multi-disciplinary and cross-functional project teams to ensure efficient and timely completion of deliverables • Key player of CMC team in cell line development, upstream, downstream, analytical, MSAT, MFG, regulatory, and quality for both early and late stage of programs • Strong CDMOs/CROs management experince • Good experience in PC and PV (e.g., PPQ, buffer validation at large scale, trouble shooting for deviation • Good knowledge of GMP and CMC regulatory requirements such as ICH, EMEA, and PDA (14-65) with CMC regulatory documentation submission (INDs) • Versatile experience for technology development, system mature model, matrix (planning and scheduling for department equipment, resources, proposal review, and non-lab work time tracking) • Highly motivated and passionate team player and quick learner with good interpersonal skills and excellent work ethic Invited speaker, chairperson, facilitator, panelist, and/or co-presenter for conferences since 2017 • Viral clearance design and strategy, March 2017 BPI West, SF, USA (Speaker) • General Considerations for Viral Clearance, Viral Safety and Viral Clearance Summit, Oct 2017 Charles River Laboratories (Speaker) • Disruptive Downstream Technologies, Jun 2018, CBI Conference, a division of UBM America’s • Speed to IND for Biologics, Oct 2018, CBI BioProcess Conference (Speaker) • Strategic CMC approaches for mAb purification process development and manufacturing, Mar 2019, Festival of Biologics, San Diego, CA, USA (Session Chair and Speaker) • Implementing ‘Manufacturing by Design’ (MbD) Strategy for Accelerated Commercial Biologics Manufacturing, Aug 2019, 11th Annual The Bioprocessing Summit 2019, Boston (co-presenter) • Biomanufacturing meeting, Proventa International, 28Oct2019, San Francisco (facilitator for a round table discussion for CEX mixed mode resin application, one of panelists for digitalization and AI in Biomanufacturing application) • Effective CMC Strategies for Downstream Process Development And Manufacturing Under An Accelerated Timeline, Mar 2020, Festival of Biologics, San Diego, CA, USA (Session Chair and Speaker) • EDUCATION: Ph.D.: Biochemistry and Molecular Biology, University of Waikato, New Zealand M.Sc.: Microbial Physiology, Zhejiang University (former Zhejiang Agriculture University), Hangzhou, China B.Sc.: Microbiology, Northwestern University, Xi’an, China PROFESSIONAL EXPERIENCE AnaptysBio, Inc. San Diego May2018–date, Director, Downstream PD, MSAT, and MFG operation • One of key chemistry, manufacturing and control (CMC) team members for project evaluation, contract assessment, person-in-plant for manufacturing (MFG) pilot and MFG campaigns • Provide valuable suggestions to upstream development (USP), downstream Development (PD), analytical development (AD), manufacture science and technology (MSAT), MFG, quality control (QC), and quality assurance (QA) • Oversee and manage CDMOs for multiple phase I/II and phase III projects for process characterization (PC), process validation (PV), viral clearance (VC), pilot, ENG, and GMP production • Providing scientific advices for process design, scale-up, gap analysis, failure mode and effects analysis (FMEA), in-process control (IPC), and regulatory filing (i.e., IND, IMPD). • Reviewing study protocols, plans, reports, MBRs, deviation investigation, and Corrective Action Preventive Action (CAPA) • Being an invited speak, chairperson, and panelist in three bioprocessing and manufacturing conferences Thermo Fisher Scientific, Princeton, NJ Aug2016-May2018 Principal Scientist, Group Leader  Led multiple (up to 5 projects): Fc-fusion proteins (MND: Motor neuron disease or ALS: amyotrophic lateral sclerosis ),biosimilars (mAbs: autoimmune disease), and other large molecules (cancer) from either batch or perfusion bioreactor to pilot and/or manufacturing scale.  Led VC, technology transfer (TT) and GMP MFG support for multiple projects  Closely working with USP, AD, QA, QC, MSAT, and MFG to implement new technology such as single pass TFF, automation/continuous chromatography, high-throughput.  Supervised team to generate a SOP for in-process stability study  Site lead: system mature model (SMM) for Technology Development  Voice of Customer from multiple project: 8/10 (NU1), 8/10(VT1)  Management: > Supervising a group of two direct reports (B.Sc. Ph.D) > In charge of department dashboard, micro-scheduler, and matrix update > Proposal review member for new project evaluation Therapeutic Proteins International (Adello Biologics), LLC, Chicago, IL, Apr 2015-Aug2016 Sr. Manager, Head of Downstream PD • Head of DSP team of 6 members including 2 managers, 1 Sr. scientist and 3 junior scientists to develop downstream process for biosimilars (G-CSF, PEG-GCSF and humira) • Managed and supported PC, buffer validation, PV, TT, and PPQ campaign for G-CSF • Led late stage PD activities such as range finding, resin reusing, in-process stability and DS freeze and thaw study, membrane sizing and compatibility study, microbial retention study…) • Led PD, MSAT, and MFG teams for the PPQ campaign success • Led PD, MSAT, and MFG teams to generate SOPs for large column packing, column, and equipment cleaning validation • Reviewed protocols, study plans, MBRs, BOMs, Forms, Deviation, CAPA, and reports for process characterization, resin reusing, filter capacity determination and validation, cleaning validation, PPQ, and process comparability study • Trouble-shot for MFG issues (large column packing qualification failure, atypical elution peak investigation, truncated pooling strategy, documentation error correction...) Patheon Biologics, Princeton, NJ, July 2012-April 2015 Sr. Scientist, • Developed a novel purification process and scale-up for gp140 protein production for HIV vaccine. • Developed and scaled-up for Collagen 7 production for Epidermolysis bullosa dystrophica (EBD) treatment for customer. • Provided scientific justification for deviation root cause analysis of viral filtration scale-up issue • In charge of viral clearance validation study for both early and late stage trials • Work closely with USP, AD, MSAT, MFG, QC, and QA. • Mentoring intern and junior staff • Earned 6 GREAT Awards for the outstanding achievements ImmunoGen. Inc., Waltham, MA Aug 2010-Jul 2012 Sr. Process Engineer, Technical Leader (Left due to change in business focus) • Developed, optimized, scaled-up, tech-transferred two mAb projects from 2L to 500L scale of cGMP facility in CMOs (IMGN853 and IMGN529) • In charge of CMO operation GMP production and built knowledge base system (e.g., mAb purification development strategy; scale-up model; viral clearance; process validation) • Authored documents: Study plan / proposal/protocol/batch records/raw materials / buffer recipes/sampling plan / writing reports; PFD / PTD; cGMP data trending / statistical data analysis/acceptance criteria determination, and summary reports) for toxicology studies • Responsible for 'Freedom of Operating” for internal IP protection purpose. • Managed a team of 2 scientists (B.S/Ph.D.) Lonza Biologics Inc., Hopkinton, MA Sept 2008-Aug 2010 Scientist, Group Leader • Responsible for multiple TT projects (Vaccine, EPO-PEGylation, biodefence product-Anthrax antigen…) • Participated scale up from bench (10L), pilot (100L) to GMP scale (1000L). • One of the leads for PC for a vaccine process • Documentation preparation / review, timeline / schedule planning, daily coordinating with USP, QC, AD, MTS, MFG and clients. • Root cause analysis for CHT large column packing failure • Assisted for IQ/OQ/PQ for new Suit 7/8 • Managed 2 scientists (B.S/M.S) Shire HGT, Cambridge, MA Jan 2007-Aug 2008 Scientist, Group Leader • Supervised 3 scientists (B.S/M.S) as well as 5 additional scientists on the project based for three GMP batch failure investigation from Elaprase™, identified the root causes of batch failure and provided scientific justification of CAPA, provided scientific evidence for post-approval improvement, prevented drug shortage to patient. • Conducted experimental designing (scaled-down model), timeline and schedule planning, report preparation/write / review, daily coordinating and supervising, master batch record and SOP preparation for Elaprase™. • Performed resin reuse and viral clearance validation study from VPRIV for Phase III and BLA filing Altus Pharmaceuticals Inc., Cambridge, MA Nov 2005- Jan 2007: Staff Scientist • Established protein purification process of oxalate decarboxylase from bacterium and oxalate oxidase from yeast, respectively • Optimized 10L fermentation, unfold/refold, crystallization, cross-link process: scaled-up from 10 mg scale to 100 g/batch, report prep, tech transfer, documentation to CMO • Qualified SDS-PAGE by silver staining method for assay 2003-2005: Sr. postdoctoral Associate, University of Massachusetts, Amherst Protein purification and proteomic study in electron transfer chain from Geobacteria. 2001-2003: Postdoctoral Associate, The Pennsylvania State University • Protein purification and characterization from a novel FMN protein family • Proteomic study of M. thermophila 07/1993-08/1993: Visiting scholar-Dept. of Biotechnology, Kansai University, Osaka, Japan 1988-1995: Lecturer, Dept. of Biology, Liaoning University, Shenyang, China, Taught microbiology AWARDS: • CEO’s Rockstar award in 2019, Anaptysbio • Annual award for outstanding achievements in 2018, AnaptysBio • Award for supporting and coaching PD and MFG team members for GMP compliance and G-CSF PPQ campaign, 11Dec2015, TPI (Adello) • Six GREAT awards from outstanding achievements between 2012 and 2014, Laureate/Gallus/Patheon Biologics • OneShire Excellence performance award in Shire Pharmaceuticals in 2007 • Annual excellent achievement award in Altus Pharmaceuticals in 2006 • The 2nd place award of outstanding graduate student research by New Zealand Microbiology Society in Cairns, Australia, 2000 • The 2nd place award by Chinese Science and Technology Society, Shenyang, China. 1992 TRAINING COURSE: • Process validation and continued verification, Kenx, 20May2020 • Leadership training: Patheon Biologics, June, 2017 • Effective technical writing for technical documents & regulatory submissions, Communication Partner, TPI, Chicago, 23Jan2016 • Leadership training, Lonza, Hopkinton, January 6 and 20, 2010 • DOE/QbD training, Lonza, Hopkinton, November, 2008 • TFF training, PALL, Portsmouth, New Hampshire, November 7-8, 2008 • cGMP training, University of Rhode Island, October 6-10, 2008 • Foundations of Leadership, Center for Creative Leadership, Rensselaer, CT, March 25-27, 2008 • Stepping up to Manager, Shire Pharmaceuticals, November 13-14, 2007 • Protein purification workshop (Amersham), Hamilton, NZ. September 1999 PUBLICATIONS: • Ding YH & Marino M, CMC considerations for continuous bioprocess design, development and manufacturing, A Chapter for the Book ‘Bio-processing, Bio-engineering and Process Chemistry in the Bio-pharmaceutical Industry – Using Chemistry, Biochemistry and Bioengineering to Improve the Performance of Biologics” (To be published in 2021 by Springer-Nature Publishers, New York, NY-USA) • Ding YH, Marino M, Zen K, Sheffer J, Almaguer N, Caddy K, and Praseuth A, Considerations for mAb bioprocess and manufacturing validation, Pharmaceutical Technology, 44 (8), p31-36, Aug2020 • Ding YH & Marino M, Points to Consider for Continuous Downstream Bioprocess and Manufacturing, BioPharm International, 33 (8), p22-26, Aug2020 • Ding YH, Marino P, and Kumar H, Antibody Purification Process Development and Manufacturing, BioPharm International, 32(12), p24-29, December 2019 • Ding YH, Marino P, Praseuth A, Sheffer J, Zen K, and Kumar H, Due Diligence for Accelerated Biologic Drug Development and Manufacturing, BioPharm International, p4-11, Apr 2019 • Ikechukwu IC, Chen G, Ding R (YH), Shave E, Kang JJ, Kang YK, Development of Purification for Challenging Fc-Fusion Proteins, BioPharm International, Volume 30, Issue 10, 01Oct2017 • Ding YH, Hixson KK, Aklujkar MA, Lipton MS, Smith RD, Lovley DR, Mester. Proteome of Geobacter sulfurreducens grown with Fe(III) oxide or Fe(III) citrate as the electron acceptor. Biochim Biophys Acta. 2008 Dec; 1784(12):1935-41. • Grujic D, Salida EC, Cachero TG, McGrath ME, Shin J, Zhang L, Ding YH, Rashid AR, Patel RJ, Yang CW, Mandaphati S, Margolin AL, Torres A, Shenoy BC. Oral Therapy with Crystalline Formulation of Oxalate Degrading Enzvme in Rodent Models with Hyperoxaluria, J. Urology (2007) May; 144 (4): 543-544 • Haveman SA, Holmes DE, Ding YH, Ward JE, Didonato RJ Jr, Lovley DR. C-type cytochromes in Pelobacter carbinolicus. Appl Environ Microbiol. 2006 Aug 25; • Ding, YH; Hixson K, Giometti CS, Stanley A, Esteve-Núñez A, Butler J, Lin W, Burns J, Khare T, Tollaksen SL, Zhu WH, Lipton MS, Smith RD, Lovley DR, Mester T. The proteome of dissimilatory metal-reducing microorganism Geobacter sulfurreducens under various growth conditions. Biochim Biophys Acta. (2006) July; 1764(7):1198-206. • Kim BC, Ching L, Ding YH, and Lovley DR. OmcF, a putative c-Type Mono Heme Cytochrome, Required for the Expression of omcB and omcC in Geobacter sulfurreducens. J. Bacteriol. (2005) Jul;187:4505-13 • Ding, YH and Ferry, JG. Flavin Mononucleotide-Binding Flavoprotein Family in the Domain Archaea. J. Bacteriol., (2004) 186: 90–97 • Ding, YH; Zhang, SP; Tomb, JF and Ferry, JG. Genomic and Proteomic Analyses of Methanosarcina thermophila Reveals the Differential Expression in Methanol- and Acetate-grown Cells of Multiple Homologs Encoding Enzymes of the Methanol:Coenzyme M Methyltransferase System. FEMS Microbiology Letters, (2002) 215(1):127-32. • Ding, YH; Ronimus, RS and Morgan, H. Phosphofructokinases from Thermotoga maritima: expression and characterization of two unique enzymes. J. Bacteriol. (2001) 183:791-794. • Ding, YH; Ronimus, RS and Morgan, H. Sequencing, cloning and high-level expression of a pyrophosphate-dependent phosphofructokinase from extremely thermophilic bacterium Dictyoglomus thermophilum Rt46 B.1. J. Bacteriol. (2000) 280:4661-4666 • Ding, YH; Ronimus, RS and Morgan, H. Phosphofructokinases from hyperthermophilic microorganisms-ancient enzymes? New Zealand Microbiology. (2000) 5: 14-19. • Ronimus, RS and Morgan and Ding, YH. Phosphofructokinase activities within the Spirochaetales and characterization of the phosphofructokinase from S. thermophila. Arch. Microbiol. (1999) 172:401-406 • Ding, YH; Ronimus, RS and Morgan, H. Purification and properties of the pyrophosphate-dependent phosphofructokinase from Dictyoglomus thermophilum Rt46 B.1. Extremophiles. (1999) 3:131-137. • Over 15 scientific publications from 198