Analytical Method Development and Validation for Therapeutic Proteins

Jichao Kang, Ph.D., Director, Analytical and Formulation Development, Laureate Biopharmaceutical Services, Inc.
Dr. Jichao Kang holds a Ph.D. in Pharmaceutics and has been working on characterization, method development, and formulation for proteins since 1995. He is an accomplished researcher with over 15 peer-reviewed journal articles and book chapters, several patents, and numerous conference presentations. He has extensive hands-on experience in most of the analytical methods for protein therapeutics. The proteins he has worked on extensively include antibodies, enzymes, and protein conjugates. His protein development experience encompasses preclinical, clinical, BLA and post-marketing commitments. He is currently the Director of Analytical Development and Formulation in Laureate Biopharmaceutical Services, Inc. Prior to Laureate, he was the department head of Analytical Development in Auxilium Pharmaceuticals, Inc. His team was one of the key parts in Auxilium's successful marketing application of Xiaflex in both US and EU. He also worked in MedImmune, PDL, and Neose Technologies.

Introduction to Biopharmaceutical Manufacturing

Marilee Brooks, P.E. Industry Consultant
Marilee Brooks has over 15 years experience in biopharmaceutical operations. She headed up the Manufacturing Science Group at Chiron Corporation, which executed several successful Technology Transfers from in-house Process Development and from contract manufacturing clients into large-scale cGMP production. She was involved in the generation of the Manufacturing section of the CMC is several successful FDA filings. Currently she is involved with University of California, Berkeley's Initiative for Research on Biopharmaceuticals Operation (IRBO) that focuses on Operational research collaborations between academia and industry. She holds a Masters degree in chemical engineering from the University of California, Berkeley.

Cell Line Development for Protein Therapeutics Manufacturing in Mammalian Systems

Ferenc Boldog Ph.D., Associate Director of Cell Line Development, Shire Human Genetic Therapies
Ferenc Boldog received his Ph.D. in Cell Biology from The University of Lorand Eotvos in Hungary. Following postdoc years, working on the fields of regulation of mammalian cell proliferation and human tumor biology, in Hungary and at the Karolinska Institute in Sweden, he continued his academic career, in the University of Colorado, focusing on positional cloning of disease associated genomic loci and generating physical maps of human chromosome 3. Later, he joined CuraGen Corporation and was responsible for identifying, and cloning novel human genes and expressing the relevant proteins using various protein expression platforms including mammalian stable cell lines. Currently he is responsible for the clinical/commercial manufacturing cell line development and cell banking functions at Shire. Ferenc has coauthored 38 peer reviewed publications and seven issued patents.

Stability and Specifications for Biological and Biotech Products

Timothy Schofield, MA, Managing Director, Arlenda, Inc.
Timothy Schofield is Managing Director of Arlenda, Inc., where he provides nonclinical statistical support to the pharmaceutical industry. Prior to joining Arlenda Tim worked in the Regulatory Affairs department of GSK supporting US licensure of vaccines, and at the Merck Research Laboratories heading the Nonclinical Statistics unit, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. Throughout his career Tim has collaborated with regulators and industry on stability evaluation of biologics and vaccines, and has coauthored industry papers on specifications and Quality by Design for biologics. Tim was the lead author of USP Chapter <1033> Bioassay Validation, and is vice chair of the USP Statistics Expert Committee. Tim led the control strategy subteam of the Quality by Design vaccine case study, and is co-chair of an industry/regulatory consortium which is developing a white paper on vaccine clinical assay development, validation, and maintenance. He received a Master of Arts degree in statistics in 1976 from the University of Pennsylvania in Philadelphia.