Billy Yang Email & Phone Number

San Carlos, California, US

Downstream Process Development and Tech Transfer of novel polyclonal antibody therapeutical products

South San Francisco, CA, US

• Initiated optimization of a PhIII mAb downstream process and demonstrated addition of an Emphaze filter to the harvest operation was beneficial for downstream processes.
• Supported analytical team’s late-stage development activities by developing methods to isolate populations of product variants, such as glycated forms.
• Used Surrogate MockV-MVM kit to investigate the restoration of Viral Clearance of a mAb AIEX step.
• Supported regulatory submission activities such as process mapping, change control and risk assessments..
• Developed protein purification methods for clinical candidate lead molecules.
• Performed material supply runs for formulation development.

South San Francisco, California, US

• Developed and established a challenging capturing chromatography for a cytokine drug candidate, including resin selection and method development. Used Robocolumns to screen binding and elution on Tecan, verified and.
• Chromatography development for a bispecific antibody: screening of conditions of MabSelect Sure capture step; established a HIC FT mode intermediate step to remove >10% aggregates after screening more than a dozen of.
• The processes were successfully transferred to manufacture for GMP
• Developed polishing step chromatography for 2 target antibodies, tested in confirmatory runs at bench and pilot scales
• The processes were successfully transferred to manufacture GLP/GMP runs
• Authorized and reviewed development reports and tech transfer reports, participated and completed tech transfers to manufacture

• Provided regular CRO down-stream bio-production services, including services strictly following manufacture batch record. From cell harvesting, protein purification on AKTA or drip columns, formulation through TFF or.
• Purified antibodies, antibody fragments, and biologics using Affinity, IEX, HIC, and Gel Filtration techniques. Purification method development and optimization. Proficient in Unicorn software and familiar on different.
• Performed downstream process development pilot studies and scale-ups for clients. Successfully transferred batch records and SOPs to CMOs for clients.
• Protein formulation and stability test.
• Performed protein analytic work including: LAL, SEC-HPLC, CIEX-HPLC, RP-HPLC, Normal-HPLC, N-glycan analysis, IEF, Western Blot, SDS-PAGE, and ELISA.
• Good knowledge of other analytic techniques such as SEC-MALS, DLS, DSC, AUC, CE-SDS and CIEF etc.

• Optimized 5L bioreactor runs of 2 mAbs expressed in CHO cells via screening or titration of: cell lines; seeding density; nutrient feeding schedule; pH and DO value; gas-flow control; impeller type and agitation speed.
• Sub-cloned of mAb GS constructs in CHO-S Cells; picked colonies and performed 48-hr-production test; further screened top clones in 5 ml and 25 ml-production tests
• Performed nutrient-feeding tests for different cell lines in shaker tubes and flasks
• Provided an internal Protein A IgG-quantitative HPLC daily service and a regular mAb variants-evaluation CEX HPLC service
• Trained new employees and interns lab-techniques and to perform routine internal services
• Adapted CHO-K1 into a serum-free suspension cell line

South San Francisco, California, US

• Assay support, including HPLC for t-PA/TNK, Affinity and Reverse Phase Analysis of antibody fragments, Nutropin Reversed Phase HPLC, and HTS quantification of IgG in CHO HCCF via protein A HPLC
• Coordinated work with others in the department to release quality results within the timeline specified for a given assay
• General lab maintenance
• Followed written procedures and protocols demonstrating attention to detail

• Antibody production, purification and analysis of ~100 mouse, chimera, and human monoclonal antibodies.
• Optimized a method for generating Fab fragments for human IgG3 molecules. Used Fab fragments and whole antibody to determine binding constants for antibody: antibody interactions
• Determined immunoglobulin quantity for human, mouse, and chimera immunoglobulin molecules using the ForteBio Octet System
• Developed a conjugation method for antibodies otherwise difficult to conjugate
• Optimized antibody production levels
• Tested multiple formulations to optimize solubility of purified antibody

Bs, Genetics &Genetic Engineering

Ms, Biochemistry & Molecular Biology