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Formulation Strategies to Prevent Protein Degradation

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  • Danny Chou, Ph.D.

    Danny Chou is the founder and President of Compassion BioSolution, a consultancy that also provides biopharmaceutical formulation development and bioanalytical services with special focus on protein aggregate and particle analysis. Dr. Chou has over 15 years of experience in Biologics Formulation Development, Protein Analytical Technology, and Drug Delivery. He has advised many clients on scientifically proven strategies for biopharmaceutical product development. Prior to founding Compassion BioSolution, Dr. Chou was a lead formulation scientist at Gilead Sciences where he successfully converted several formulations of monoclonal antibodies from low concentration IV formulations to high concentration formulations that are more stable and can be easily administered using a pre-filled syringe.

    In 2011, Danny Co-founded NorthStar Bio, the first company in the world that was dedicated to providing particle characterization and consulting services to the biopharmaceutical industry. Before this, Danny was the Director of Pharmaceutical Development at Integrity Bio, a CRO that specializes in formulation development and cGMP fill and finish of biopharmaceuticals. Dr. Chou also was a Drug Product Process Development Scientist at Genzyme Corporation and Amgen Corporation, where he was responsible for managing global commercial formulation/fill-finish technical support, and established a global framework for extractable/leachable (E/L) risk evaluation for manufacturing operations throughout the world. In the past decade, Dr. Chou has developed stable pharmaceutical dosage form for proteins, monoclonal antibodies, peptides, and oligonucleotides for clients ranging from small start-up biopharmaceutical companies to Fortune 500 pharmaceutical companies. Dr. Chou received his PhD from the University of Colorado Center for Pharmaceutical Biotechnology and his PharmD from the University of Florida.

  • Tim Menzen, Ph.D.

    Tim Menzen is a pharmacist by training and received his PhD in the group of Prof. Dr. Wolfgang Frie├č at the LMU in Munich, Germany. Tim received the Carl-Wilhelm-Scheele award of the German pharmaceutical society (DPhG) for the outstanding achievements during his PhD thesis. His research focused on temperature-induced unfolding, aggregation and interaction of mAbs, which resulted in three publications. During his time as PhD student Tim already worked part-time for Coriolis Pharma, a science driven CRO for formulation and lyophilization development of biopharmaceuticals. In March 2014 Tim fully joined Coriolis. At Coriolis, he is leading formulation development projects for biologics and is involved in the implementation of novel technologies. Moreover, he is involved in internal research projects at Coriolis and in scientific relations. Tim is chair-elect of the AAPS focus group on Protein Aggregation and Biological Consequences (PABC).

  • Sreedhara Alavattam, Ph.D.

    Sreedhara Alavattam has a PhD in Chemistry and postdoctoral experience in Biochemistry and Molecular Biology. He is currently a Principal Scientist and Senior Group Leader at Genentech, Inc and has over 17 years of experience in the biotechnology industry working with biologics (peptides, proteins and nucleic acids) through various clinical trials and marketing applications. Prior to Genentech he was at Battelle and Johnson & Johnson wherein he worked on proteins as well as small molecule formulation development for controlled release applications. Additionally, he has worked on developing novel delivery devices using electro-hydrodynamic technology for aerosol generation for both pulmonary and non-pulmonary applications. He has over 45 publications, 4 book chapters, 2 issued US patents, several patent applications and is an invited speaker at various national and international conferences. Currently he is also an adjunct associate professor at Univ. Kansas and a scientific adviser for J. Pharm. Sci and serves as a reviewer for Mol. Pharmaceutics, Pharmaceutical Research, J. Pharm. Sci, Biotech. Progress and mAbs.

August 3, 2017
Thu 12:30 PM EDT

Duration 1H 30M

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