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Webinar

Unlocking Efficiency: Strategies for Expedited Biotherapeutic Development

Available on-demand
60 Minutes

Join us for this important and timely look at the critical role key process development approaches can play in shortening development timelines for biotherapeutics. 

You’ll gain key insights on:  

  • Risk-mitigation strategies that shorten time to BLA
  • Key considerations in utilizing flexible development platforms 
  • Optimizing integration between Process Development and Manufacturing teams, and the crucial role MSAT plays
  • Managing all aspects of process development with manufacturing in mind
  • And more 

Speakers

Minni Aswath

Minni Aswath

Minni Aswath is Senior Director of Process Development at Bionova Scientific, a biologics CDMO based in Fremont, California.  Minni leads the company’s process development team and is also instrumental in Bionova’s tech transfer and process characterization projects as well as leading innovation work related to purification strategies. With more than 20 years as of end-to-end experience in biologics development and commercialization, Minni spent several years at Boehringer Ingelheim in various technical leadership roles, including protein purification, process validation, process development and technology transfer. In her most recent role there, Minni led a team of scientists engaged in downstream process development, NPI and manufacturing support, process characterization (PCS), small scale validation studies, and regulatory filings (IND and BLA). She was responsible for 10 late stage and commercial programs as the interim head of Process Validation.

Minni was also a key member of CMC teams providing technical leadership, accountable for coordination with teams within the Process Science department as well as other departments in the organization. She led successful technical transfer, NPI, and process characterization/ validation activities for several major CMB, biosimilars, and novel monoclonal antibodies in clinical and commercial phases.

Before Boehringer Ingelheim, Minni held scientific roles at Merck Research Labs, Perseid Therapeutics and Maxygen, Inc.

Minni earned her M.S. in Microbiology and Molecular Biology at San Jose State University and her B.S. in Microbiology at The Ohio State University.

Daniel Bock

Daniel Bock

Daniel Bock is Senior Director of Upstream Process Development at Bionova Scientific. In this role, Daniel leads the upstream side of the company’s process development team and is also instrumental in Bionova’s tech transfer and process characterization projects as well as leading innovation work related to cell culture strategies.

Daniel has more than 15 years experience in upstream process development, including extensive experience in Early and Late Phase, Process Characterization, Tech Transfer, Disposables and Stainless Steel, GMP and non-GMP programs.  Prior to Bionova, Daniel held upstream process development roles at Boehringer Ingelheim in Biberach, Germany;  Shanghai, China; and Fremont, California.
 
Daniel earned his Master of Science in Chemical & Biotechnology Engineering at the University of Applied Science, Hamburg, Germany and Technical School of Chemistry, Dormagen, Germany.

Register here to watch on-demand!

Duration:
60 Minutes