Eric Chan Email & Phone Number

New York, Ny, Us

Miami, Florida, Us

Pennington, New Jersey, Us

- Led a team of 5 scientists & engineers to develop and implement scalable high-yielding processes using novel technologies for the production of plasmid DNA and viral vectors, related new modalities to support early and late-stage gene therapy programs. - Responsible for tech transfer processes from China to the US production site. Supporting US site readiness by drafting process description, qualification protocol, master batch records, conducting facility fit exercise, process risk/gap assessment, BOM, comparability studies & etc. -Collaborated with the manufacturing and validation team to execute IO/OQ/PQ, FAT, SAT as well as conducting due diligence to support engineering & GMP production runs.

Us

- Led a team of scientists in optimizing AAV triple transfection processes (DoE/Qbd approach) to support IND filings and GMP production campaigns. Leading tech transfer efforts in authoring & reviewing development, process description, facility fit reports, BOM, master batch record. Collaborating with the manufacturing team on MCB generation, Veeva systems & process troubleshootings, interacts heavily with cross functional CMC teams.- Responsible for successfully scaling up and down from bench top/pilot bioreactors to production bioreactors (3L, 10L, 50L, 200L, 500L to 1000L). Successfully bridging various scales and systems (Shake flasks, DASGIP, Cytiva XDRs and Sartorius STRs), showing comparable cell culture performance, productivity and product quality profiles.- Successfully optimized existing manufacturing process (from process A to B) to improve efficiency with 2x yield increase & impurity reduction. Conducted PoC N-1 intensified perfusion process in laboratory scale (10L) to support next Gen manufacturing platform, resulting a >2x increase in productivity, % full capsids as well as a >2x reduction in impurity profiles (Encapsidated hcDNA and aggregation) with comparison to process B.

Global, Global, Oo

- Built technical credibility for the Cytiva Cell Culture business by providing scientific and strategic support of upstream customers for cell culture products and new services offerings.- Worked with the commercial team through a specific territory plan to find Cytiva Cell Culture media business opportunities and provided innovative solutions to meet exceed financial sales targets.- Wrote project proposals & SOW by working with internal operation technical leads and product managers, participated in execution of media development collaborations services, and provided high level pre and post sales process development support.

Lawrence Township, Nj, Us

- Led a team of two scientists in early stage bispecific antibodies (BsAbs) process development, tasks include but not limited to initial platform fit exercise, media/feeds screening, RCBs clone selection, clone stability studies(Ambr15), high throughput process development runs (Ambr250 & 3L bioreactors), process lock, confirmation, tox material generation run in pilot SUB scale (50 & 250L), & GMP tech transfer to internal manufacturing site.- Upstream representative in high level CMC company team meetings pertaining to resource allocation, process development deliverables and strategic planning to meet clinical milestone timeline set forth by the company. Supported GMP production run by using scale-down bioreactors to troubleshoot/overcome the challenges encountered in manufacturing.- Designed OFAT experiments and DoE studies to understand the impact of cell culture processes on product quality (with a main focus on glycosylation and PTMs)

Lawrence Township, Nj, Us

Waltham, Ma, Us

- Supported BLA filing of Felzartamab, upstream PD team lead on scale down model qualification and acceptance criteria establishment (equivalence tests, 3SD & tolerance interval approach). Led the upstream PD process characterization efforts with statistician, MSAT, manufacturing & cross functional CMC teams to conduct PHA, SDMQ, DoE, FMEA, risk assessment, mitigation, TTP and in process control strategies (IPCS).- Statistical process control, multivariate analysis for biologics processes. Setting proven acceptable range (PAR) based on Monte-Carlo simulation with a process failure rate of <0.5%. Mapped out critical process parameters (CPPs) to support FMEA & IPCS.- Primary author in SDMQ/N-1 PC/N PC/Harvest reports, co-authored FMEA & IPCS reports to support CMC/BLA documentation for Felzartamab. Worked closely with GMP production team, QA & PM in readiness of the process performance qualification runs (PPQ).

杭州, 浙江省, Cn

- Responsible to generate research grade reagents (antibodies, Fc-fusion proteins, enzymes, cytokines and etc.) to support discovery programs in house, leading a group of junior scientists to oversee wide range of bioprocess operations from cloning, expression, purification and basic analytical testing.- Successfully developed a semi-high throughput antibody bioprocess production flow that takes 2 weeks from cloning to purified material by utilizing 96 wells platforms from Clontech ‘s Infusion HT cloning technology, ThermoFisher’s Expi HEK293/CHO transient expression system and GE’s MabSelect Prism A filter plates.- Served as an upstream subject matter expert to engage with potential CDMO vendors in the space of cell line development, stability studies, cGMP cell banking, early phase upstream process development and potential GMP production.

Waltham, Massachusetts, Us

- Led the upstream PD effort on biosimilar tuning of Ustekinumab by alternating process parameters & media formulation/supplements to match the approved originator’s quality profile (N glycans & PTMs). Over 100 perfusion runs were executed with 95%+ success rate, the process was successfully transferred to GMP production site and received EMA approval in October 2023.- Developed and optimized mammalian cell culture processes to support GMP production of recombinant proteins and antibodies in production bioreactors (up to 2000L) to improve productivity and product quality. Worked closely with the global manufacturing team on process tech transfer, troubleshootings & deviation management.- Led development projects as an upstream lead, responsible for writing masterplan, SOPs, tech transfer and development reports. Strong cross function interaction with clients, program managers, analytical and downstream groups to design, analyze and execute experimental plans based on defined deliverables and timelines. Trained and mentored junior scientists and provided technical leadership in the team.

Melbourne, Vic, Au

- Responsible for managing CMOs and CROs for bio-analytical methods establishment and testing of human Mesenchymal Stem cells (MSCs) in 2D cell culture environment. Task includes analytical assay development/transfer/validation to support BLA filing.- Worked closely with QA & project management to support in process GMP sample testing, QC lot release, stability data package reviews, deviation management, OOS & CAPA.- Optimized QC T cell functional/FACS based assays to exhibit the immunomodulatory effect of MSC on CD3/CD28 induced hPBMC by assessing the level of IL2-Rα, TNFR1, TGFβ and SDF-1. Validate assays per ICH Q2B & USP<1033> guidelines.

Indianapolis, Indiana, Us

- SME in molecular cloning and protein expression, cloned ~500 constructs a year to support company's pipelines. Enhanced protein/antibody expression level by manipulating promoters, leader signal sequences and codon optimization.- Developed semi-automated high through-put antibody cloning platform using In-fusion homologous recombination technology, which sequences of variable regions were pulled out and cloned into GS expression platform as dual vector in one reaction to improve yields, maintained vector database using vector NTI. - Characterized antibodies and reagent proteins through transient transfection, assess binding and expression level using Octet ProA biosensor, western blotting, ELISA, FACS, and SE-HPLC.

Indianapolis, Indiana, Us

- Responsible for performing cells based ADCC, CDC and ELISA based binding assays to support all stages of therapeutic antibody development. Optimized Fc effector function ADCC NFAT reporter gene bioassays to establish a new system suitability using anti CD20 Rituxanmab and CD20 expressing Wil2-S line to improve assay range, linearity and LLOQ.- Responsible for generating critical reagents to support effector function assays by cloning the extracellular domains (from NCBI database) of various members of the FcγR family into expression vectors. Cloned full length human FcγRIIIa (F/V) into lenti virus vector to generate stable Jurkat line to support ADCC assay development. - Established Fut8 KO CHO-K1 line to enhance afucosylation to achieve better ADCC, optimized ADCC and CDC assays to screen therapeutic mabs by establishing system and sample suitability. Preparation of technical reports and SOPs, present data to support IND.- Co-led a GPCR based research project, developed calcium flux and 3D cell proliferation assays to screen antibody candidates, established Protease-activated receptors (PARs) overexpressed cell line verified by FACS for assay controls.

Farmingdale, Ny, Us

- Developed novel fluorescent cell assays in flow cytometry (FACS), fluorescent microscopy and 96/384 wells plate cell-based platform for high-throughput drug screening that offer a superior assay signal window, improved lower detection limit, higher specificity, higher Z’-score and low intra/inter-plate CVs than traditional commercial assays.- Developed death pathway assays for monitoring compound effects on apoptosis, autophagy, mitophagy and necrosis. Optimized toxicology assays for monitoring compound effects on the function and viability of human cancer cell lines.- Developed 8 commercial assays, coauthor of 5 scientific abstracts and 3 publications.

Morris Plains, New Jersey, Us

- Developed processes using bench scale and GMP pilot scale bioreactors (Stainless steel) to produce therapeutic antibodies. Responsible for bioreactor operations such as assembling, SIP, CIP, pressure testing, buffer prep, seed train expansion & troubleshooting.- Delivered high yielding stable mammalian cell lines for production of monoclonal antibodies. Generated stable cell lines using CHO/SP20, tasks included GS/DHFR gene amplification, clone selection, expansion, sub-cloning (limiting dilution) and cell banking. - Developed successful recombinant bacterial expression of immunotoxic (Ranpirnase) and mammalian expression of immunocytokines (Interferon α-2B, G-CSF) that conjugate with various kinds of IgG antibodies to make antibody drug conjugates (ADCs). Performed small scale purification and characterization of the ADCs using SEC, CEX, IEF, SDS-PAGE and western blot. Carried out cell-based potency assays to assess the activity of the ADCs. Co-authored 4 scientific abstracts of Dock and Lock antibody conjugation technology.

New York, Ny, Us

- Designed primers to clone over 50 proteins screened from yeast-2-hybrid system into Flag/GFP tagged vectors for the study of protein-protein interaction.- Confirmed protein interactions fished from yeast-2-hybrid by Co-transfection of two fusion proteins into HEK293 cells. Analyzed interactions by Co-IP, SDS-PAGE and western blot.- Cultured Myoblast (C2C12) cells for endogenous actin associated Myopodin and established a stable cell line of Myopodin knockout using small interfering RNA (siRNA) technology. Analyzed the effect of down regulated Myopodin by cell-based assays.- Responsible for laboratory upkeep and maintenance including, inventory, purchasing, reagent preparations & etc.

- Conducted fieldwork to obtain soil and air samples in the city.- Involved in testing of the samples and writing environmental assessment report.