Speaker Bios

Kevin Knapstein, Manager, Bioprocess Scale-Up Facility, Biotechnology Research and Education Program University of Maryland

Kevin runs the Bioprocess Scale-Up Facility and oversees bacterial or yeast fermentation and downstream contract research. He has worked with local biotech companies as well as several others both foreign and domestic providing scale-up and process development. He has over 15 years of experience in cell propagation, process development, upstream processing and downstream processing. Kevin has helped develop course curriculum for 4 undergraduate courses and one graduate course in bioengineering. In addition, he has aided with workforce training and mentoring for 11 years. He has been responsible for placing many students in the local biotech industry through his lab or courses he teaches. Kevin currently teaches two bioengineering courses based on pharmaceutical production and bioprocess engineering. Prior to working in the BSF, he worked as a bioprocess engineer at Human Genome Sciences working in downstream process development. Kevin has a B.S. in Biological Resources Engineering and Physiology and a Masters in Bioengineering from the University of Maryland.

Andrew Lees, Ph.D., Scientific Director, Fina Biosolutions; Associate Professor, University of Maryland, School of Medicine

Andrew Lees, Ph.D., is the founder and scientific director of Fina Biosolutions LLC, in Rockville, MD.  Dr. Lees has been teaching biochromatography for 15 years.  Dr. Lees is an expert in the chemistry of conjugate vaccines with over 20 patents to his name and an author on over 60 peer-reviewed articles. Conjugation chemistry developed by Dr. Lees is used by GSK, the Serum Institute of India, the Chengdu Institute of Biological Products and others in their Streptococcus pneumoniae and meningococcal conjugate vaccines.  

Dr. Lees is also an Associate Professor at the Center for Vaccine Development at the University of Maryland School of Medicine.  Dr. Lees was formerly Director of Protein Purification and Macromolecular Sciences at Biosynexus, Inc and Director of Vaccine Development at Virion Systems, Inc. Andrew Lees holds a BS in Chemistry from Harvey Mudd College (Claremont, CA) and a Ph.D. in Biophysics from The Johns Hopkins University (Baltimore, MD).

Lois Ann Beaver, Director International Harmonization at Food & Drug Administration (Ret.) LAB Enterprises   

Upon graduation in 1963 with a BS in Chemistry and Mathematics, from Rosary Hill College, Lois Ann Healy (now Beaver) joined the U.S. Food and Drug Administration in Buffalo, NY as an analytical chemist where she developed a deep interest in separation science that continues to this day. At FDA headquarters she held several positions including overseeing the trace analytical work of FDA field labs, mass spectrometry projects and official method development. An idea conceived while working in the lab led to a dozen patents on a system and apparatus for real-time multi-dimensional chromatography, and the founding of an instrument company called Varex Corp. that functioned for 10 years in Rockville, MD. The last period of her multi-decade FDA career involved international activities in the Office of the Commissioner where she served as liaison with international organizations such as WHO (World Health Organization), OECD, (Office of Economic Cooperation and Development) and APEC, (Asia Pacific Economic Cooperation), served on numerous US delegations, and was a member of the FDA Pharmaceutical Quality Council that conceived and developed quality by design. Lois also led international projects on anti-counterfeiting of medical products and good manufacturing practices in emerging countries and established a pharmaceutical information center in Cairo. She is a member of the Washington Chromatography Discussion Group, the ACS Chemical Society of Washington, and the Chromatography Forum of the Delaware Valley and is on the organizing committees of HPLC 2016 and PREP 2016.

Coral Fulton, Viral Clearance Study Director, Texcell- North America

Coral Fulton is a Study Director at Texcell - North America, where she has supported numerous viral clearance studies for different biologics, including monoclonal antibodies, recombinant proteins, recombinant adeno-associated viral vectors, and medical devices, for both IND and BLA enabling studies. She was also heavily involved in developing the Texcell - North America level of services program and continues to contribute to virus purification efforts to obtain extra pure virus stocks for viral clearance studies. Prior to that time, she worked in the process development group at MedImmune, where she began her career in the viral clearance group coordinating and performing the technical execution of the virus validation studies at different contract research organizations. She then moved on to the research support group, where she purified material for in vitro and in vivo studies. Coral has a Bachelor of Science in Biotechnology from Pennsylvania State University.

Amanda Zhang, MS,  Research Scientist II, REGENXBIO, Inc.

Amanda Zhang is a Scientist at RegenxBio’s Vector Core group.  Previously, at MacroGenics and Salubris Biotherapeutics, as a protein chemistry scientist, she developed robust, efficient, and scalable purification processes and technologies required for the advancement of diverse and extensive portfolios of monoclonal and recombinant proteins.  After working in the antibody field with over a decade of experience, she joined RegenxBio, the global leader in the development of adeno-associated virus (AAV) vectors and the development of gene therapies. Working closely with Research and Early Development group, Amanda has been responsible for the purification processes of non-GMP recombinant AAV vectors, in support of pre-clinical and IND enabling studies.

Xuemei He, Ph.D., R&D Manager, Process Chromatography, Bio-Rad Laboratories

Dr. Xuemei He is the manager of Chromatography Media Chemistry at Bio-Rad Laboratories. She holds a Ph.D. degree in Biological Chemistry, and has over 20 years of experience in the field of biomolecule separation and characterization. Her laboratory is concentrated on the development of new chromatography media for process-scale production of protein pharmaceuticals, with an emphasis on the removal of residual process- and product-related impurities during polishing purification stage.

William H. Rushton, MS, Chromatography Support Scientist, Bio-Rad Laboratories

William Rushton is a Process Chromatography Support Scientist for Bio-Rad in North America.  He obtained a M.S in Biomedical Sciences from Philadelphia College of Osteopathic Medicine in 2005 and his B.S in Biology from St. Joseph’s University in 1994. Prior to Bio-Rad he worked at Centocor (wholly owned subsidiary of Johnson and Johnson) from 1997-2007 in the Process Development Group. While there he worked on ReoPro®, Remicade® and developed the downstream purification processes for Simponi® and Stellara®. In 2007 he joined Charles River Laboratories as the manager of the Process Evaluation/Validation group performing viral clearance studies for Pharmaceutical and Bio-Tech companies. Upon leaving Charles River in 2009, he supported the BLA filing and post marketing activities for Xiaflex® at Auxilium Pharmaceuticals as a Senior Scientist in the Process Development group. His work resulted in development of highly purified versions of the collagenases to improve analytical assay sensitivity as well as column validation work.

Mark A. Snyder, Ph.D., R&D Manager, Process Chromatography Applications, Bio-Rad Laboratories

Dr. Mark A. Snyder is Manager of the Process R&D Applications Group in the Process Chromatography Division of Bio-Rad Laboratories. He received a B.S. from the Massachusetts Institute of Technology and his Ph.D. in biochemistry at the University of California, Berkeley. He has been responsible for many developed processes, including Bayer’s current-generation licensed recombinant Factor VIII purification process. He is experienced in process troubleshooting, optimization and validation. His work has been published in numerous peer reviewed journals.