Considerations on Impact of Raw Material Variability in Gene Therapy Manufacturing: Applying Lessons Learned From Biologics Manufacturing

22nd October 2020 | 10:00 am EST | Presented by Aaron Mack, Engineer at Biogen and and Greg Stromberg Interim Leader of Global Manufacturing Material Sciences at Biogen,, Dr Lisa Dixon, Acting National Director, Animal Product Import and Export at US DA |WATCH FOR FREE

As the number of cell and gene therapy products grows it is important to consider aspects of gene therapy production process robustness, and one key characteristic is the variability of incoming raw materials. Understanding and controlling raw material variability is an important aspect of process development, characterization, and commercialization. In the recent history of therapeutic protein production with cell cultures, many problems caused by raw material variability were only discovered post-commercialization, and failure to understand and address key raw material variability during process development led to costly underperformance and batch failure. In this article, we consider some known sources of raw material variability and specifically, those that have been known to impact cell culture production processes. Trace element impurity variation, particularly iron, copper, manganese, and zinc, are candidates for high process impact risk. Compositional variation of undefined material (i.e., fetal bovine serum [FBS]) is another important potential failure mode. This includes known nutrient components, such as amino acids and cholesterol, as well as unidentified components, such as growth factors. Cell and gene therapy processes also include relatively new materials for cell culture, such as plasmid DNA and the transfection agent polyethyleneimine, the understanding of the variability of which must be considered.

Presented by Aaron Mack, Engineer at Biogen

Aaron Mack is a Senior Engineer at Biogen and is responsible for providing global technical raw material support and expertise in the Materials Science group as a part of Manufacturing Sciences. His current focus is on technical supplier engagement, supplier innovation, and raw material control and monitoring strategies across modalities. Mr. Mack has a B. S. in Biomedical Engineering, and M. S. in Molecular Science and Nanotechnology, and has previously led projects installing large scale manufacturing equipment, assessing raw material amenability to viral risk mitigation (VRM) methods, producing Adeno Associated Virus (AAV) for gene therapy and sensing applications, and implementing R&D, pilot scale and large-scale manufacturing processes. He joined Biogen in April 2017 and brings expertise in pharmaceutical research and engineering, with over 13 years of experience in process development and 9 years of experience in GMP manufacturing. Additionally, he has contributed to the Biophorum Operations Group Raw Material Variability (RMV) team since March 2018 and the Cell and Gene Therapy (CGT) team since February 2019.

Greg Stromberg: Interim Leader of Global Manufacturing Material Sciences at Biogen

Greg Stromberg is an Interim Leader of Global Manufacturing Material Sciences at Biogen, a biotech company with headquarters in Cambridge, Massachusetts, and manufacturing arms in several locations, including Research Triangle Park, North Carolina, where he is located.  His responsibilities include interim leadership of the material science department, a team’s mission is to consistently deliver high quality raw materials for on time drug substance and drug product manufacture.  Greg also leads the manufacturing sciences strategy group to support the gene therapy modality.

Prior to joining the material sciences and gene therapy teams, Mr. Stromberg held leadership positions at Biogen in Process Analytics and Advanced Process Control in Manufacturing Sciences.  Mr. Stromberg has also worked in gene and cell therapy research and development as a staff scientist at Athersys, Inc. (Cleveland, Ohio), where he worked on the Synthetic Micro Chromosome gene therapy platform, and at the University of Michigan (Ann Arbor, Michigan), where he conducted stem cell research and developed cell culture production systems.

Mr. Stromberg received his B.S. in Genetics from Michigan State University and his M.B.A. in BioPharma Management from North Carolina State University.

Followed by USDA Update on Imports of Bovine Serum for Product Manufacture

Bovine serum is a commonly used raw material in the manufacture of products requiring cell cultures, such as vaccines, cell, and gene therapy products. USDA APHIS regulates the import of bovine sera for certain exotic animal diseases, based on the country where the blood product is collected and processed. General USDA APHIS import requirements for bovine serum, a recent risk assessment, chain of custody considerations, and implications for import of bovine serum that has been in multiple countries will be discussed.

Presented by Dr Lisa Dixon, Acting National Director, Animal Product Import and Export U.S. Department of Agriculture

Dr. Lisa Dixon is the Director of Animal Product Imports with the U.S. Department of Agriculture, Animal and Plant Health Inspection Services (APHIS), Veterinary Services (VS), Strategy, and Policy. She currently manages a staff of 10 veterinary medical officers responsible for the permitting, trade negotiating, and policy making for imports of animal products/byproducts and organisms and vectors.

Dr. Dixon is a 1999 graduate of Tuskegee University School of Veterinary Medicine and received her Master’s in Public Health in 2011 from Walden University. After clinical practice on small, large, and exotic animals, she entered the federal workforce in 2008 with Food Safety and Inspection Services as a Supervisory Public Health Veterinarian. She joined APHIS in 2013 as a veterinary medical officer overseeing regulatory policy and permitting for imports of animal byproducts such as fetal bovine serum, mono- and polyclonal antibodies, and diagnostic samples, and other research materials.

Dr. Dixon additionally oversees the USDA Approved Establishment Program, which consists primarily of taxidermists, for treating and handling imported hunting trophies. She works closely with several federal agencies including Customs and Border Protection for handling animal products and byproduct imports. She also serves as a subject matter expert for the USDA Regulated Garbage Program.

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