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Creative biotechnology professional with over 30 years in the biopharmaceutical industry. Experience spanning research, development and commercial stage programs including tech transfer and outsourcing. Managed and directed a multidisciplinary staff of scientists. Led the development of multiple early stage clinical programs focused on the generation of recombinant protein production cell lines for preclinical supply and GMP manufacture. Interest in innovative approaches to process improvement and new technologies. Effective and clear communicator able to achieve program objectives.
H Prentice Consulting
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PrincipalH Prentice Consulting Mar 2013 - PresentExpertise:- Process development for recombinant protein production- Evaluation and optimization of existing processes- Cell line generation, cell banking and cell line characterization- Cell culture media development and optimization- CMC program management- Analytical development- CMO and CRO selection, management and tech transfer- Due diligence review- Technical and regulatory report review and preparation- Laboratory design and equipment selection- CMC regulatory strategy and submission preparation
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Vice President Technical DevelopmentApogee Therapeutics Jun 2023 - Oct 2023Program lead for drug substance process development and manufacturing. Development of regulatory strategies and preparation of CMC regulatory submissions. Advance late stage discovery candidates into IND-enabling CMC development. -
Vice President Technical DevelopmentInvivyd Jul 2020 - Mar 2023Set direction and ensure execution of all technical development activities including process development, analytical development, technology transfer and validation from early-mid stage product development through commercial manufacturing. Led CMC regulatory efforts for IND and BLA preparation. Delivered on four rapid to phase 1 programs each in under 5 months from transfection to phase 1 supply over the course of 2.5 years. Completed one program up to BLA preparation in under 2 yrs. -
Associate Director, Biologics Process DevelopmentMomenta Pharmaceuticals Jan 2011 - Mar 2013Process development of follow on biologics using proprietary technologies to meet product targets. Oversight of multiple CMO/CROs for process development, scale-up, media development, cell line generation, GMP cell banking and testing. -
Manager Ii Of Expression TechnologiesMillipore Mar 2008 - Dec 2010Development and evaluation of novel mammalian expression technologies in the areas of cell line screening, vector design, host cell engineering, transfection, novel supplements, and assay design. Multiple collaborations with industrial and academic partners -
Principal ScientistMomenta Pharmaceuticals Inc 2006 - 2008Management of a CMO for large scale production of a critical reagent enzyme for an API and identification of a replacement GMP CMO. Oversight of the process development and analytics for six E. coli derived enzyme processes and their transfer to contract manufacturing
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Principal ScientistBiogen Idec 1996 - 2006Led or participated in the development of cell lines and processes for over seven clinical and commercial programs and the transition of these programs from Research into Development.Co-led a team for the development of a commercial cell culture process as well as a Process development team for an early phase clinical candidate including the coordination of the CMC section of the IND filing. Specified and implemented automation for the development of high throughput methods for cell line development Participated in the development of a guideline used by the process development group for the development of clinical and commercial phase processes and led a team to generate strategies for accelerated development of recombinant antibodies from cell line generation to IND filing. Familiar with requirements for Regulatory requirements for recombinant products. Experienced in preparing IND and BLA filings. -
Principal InvestigatorAres Advanced Technology 1994 - 1996Development of expression vectors and cell line generation for biotherapeutics in mammalian and insect cells. Generation of a novel expression technology in mammalian cells.
Holly Prentice Skills
Holly Prentice Education Details
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Molecular And Cellular Biology -
Geology -
Biology
Frequently Asked Questions about Holly Prentice
What company does Holly Prentice work for?
Holly Prentice works for H Prentice Consulting
What is Holly Prentice's role at the current company?
Holly Prentice's current role is Principal at H Prentice Biotechnology Consulting.
What is Holly Prentice's email address?
Holly Prentice's email address is ho****@****ast.net
What is Holly Prentice's direct phone number?
Holly Prentice's direct phone number is +178153*****
What schools did Holly Prentice attend?
Holly Prentice attended Harvard University, University Of Chicago, Rensselaer Polytechnic Institute.
What skills is Holly Prentice known for?
Holly Prentice has skills like Biopharmaceuticals, Biotechnology, Technology Transfer, Protein Chemistry, Cell Culture, Molecular Biology, Assay Development, R&d, Life Sciences, Lifesciences, Cell, Gmp.
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