Michael (Misha) Shamashkin Email & Phone Number

Boston, MA, US

Cambridge, Massachusetts, United States

Responsible for process development and production of therapeutic cargo

Cambridge, Massachusetts, United States

• Developed an end-to-end Drug Substance process for fusosomes (lentiviral vectors comprising tissue-specific fusogens and transfer genes) and virus-like particles (VLP) for direct in vivo administration.
• Managed a team of 7 scientists and engineers in upstream, downstream, and formulation functions and supervised production of Drug Substance and Drug Product batches.
• Contributed to defining a phase-appropriate control strategy for in-process testing and release.
• Transferred Upstream, Downstream, and Fill/Finish processes to CDMOs.
• Technical subject matter expert in a Quality Audit of a CDMO.
• Authored sections of the Pharmacy Manual, the GLP Tox study protocol, and the CMC module of an IND.

• Built downstream process development lab and hired and trained staff on purifying lentiviral vector (LVV).
• Designed a scalable downstream process for broad spectrum of fusosomes and virus-like particles (VLP) for direct in vivo administration.
• Developed stable frozen Drug Product formulation and designed an infusion set configuration.
• Transferred Fill/Finish process to a CDMO and served as a Person-in-Plant during the execution of GMP batches.

Cambridge, MA

• Managed a team of 4 scientists and engineers to develop early and late-stage manufacturing processes for mRNA Drug Substance.
• Developed and implemented a new custom affinity resin with 2x binding capacity for large mRNA.
• Invented and implemented novel mRNA synthesis methods resulting in a specific product profile.

Cambridge, Massachusetts, United States

Cambridge, MA

Centers For Therapeutic Innovation--Boston

• Technical Lead for translation of recombinant protein candidates from Discovery to Pharmaceutical Sciences.
• Performed biophysical screening, selection, and molecular assessment of lead molecules.
• Developed prototype purification processes, characterized product-related impurities, performed stability studies, and prepared knowledge transfer packages for the initiation of development activities.

Waltham, MA

• Evaluated novel tools in the company’s disposable chromatography portfolio.
• Developed procedures for packing and cleanability testing of large scale chromatography columns.

Cambridge, MA

• Led a team of three scientists to develop a process for purification of enzymatically glycosylated intravenous immunoglobulin (IVIG).
• Developed downstream purification of an E. coli derived recombinant sialyltransferase enzyme and transferred the process to a CMO.

Andover, MA

• Responsible scientist for development of capture and polishing chromatographic steps for mAbs, fusion proteins, cytokines and blood clotting factors.
• Developed liquid and lyophilized drug product formulations of mAbs and Fc-fusion proteins for Phase I clinical trials. Characterized drug product by HPLC, SDS-PAGE, Karl-Fischer titration, spectroscopic and.

Cambridge, MA

• Developed crystallization conditions for a variety of proteins and peptides.
• Performed high-throughput screening and optimization of crystallization conditions

M.S., Chemistry

Certificate, Biotechnology Engineering

B.S., Chemical Engineering