Oklahoma City, OK – February 8, 2021 – Cytovance® Biologics, a leading biopharmaceutical contract development and manufacturing organization (CDMO) of mammalian, microbial and gene therapy biologics, announces its first webinar of the 2021 series: Regulatory Strategies for Gene Therapy Product Development. The webinar set for March 4, 2021 at 12pm Eastern time will be presented by Dawn Wofford, Director of Regulatory Affairs for Cytovance and will feature the current state of regulatory issues around gene therapy product development, key challenges for manufacturing controls and other insights in navigating the path to commercialization.
“We are experiencing an exciting time in the biotech industry with products being developed at an accelerated rate,” stated Ms. Wofford. “The regulatory landscape for gene therapy is constantly changing and global harmonization has yet to be aligned. By understanding the regulations and guidance documents set forth by the global regulatory agencies, we can better address key challenges – including how the global pandemic is shaping and/or repurposing emerging therapeutics,” Ms. Wofford added.
This webinar will appeal to pharmaceutical and biotechnology professionals in the areas of gene therapy product development, regulatory and quality. Attendees will learn about navigating the regulatory landscape; overcoming hurdles from clinical trials, manufacturing and regulatory challenges; and leave with a better understanding of the emerging regulatory requirements.
To reserve your seat, click here to register: Regulatory Strategies for Gene Therapy Product Development. Other topic areas in the Cytovance webinar series include: Analytical Development featuring Mass Spectrometry, plasmid DNA and Mammalian Cell Culture. Stay informed of these events along with other industry conference connections at https://www.cytovance.com/about-us/events.
About Cytovance® Biologics
Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs) from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines, and other biological products, including plasmid DNA and cell-based therapeutics. In addition to its clinical and commercial CGMP API manufacturing services, Cytovance offers well-integrated development services supporting the entire product lifecycle, including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. A centralized, responsive program management team coordinates all critical chemistry manufacturing and controls (CMC) activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support. Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.
Cytovance offers deep industry expertise and unique customized services for the scale-up and CGMP manufacture of protein-based therapeutics; from early-stage pre-clinical development to commercial production, for both mammalian and microbial. Further information can be found at https://www.cytovance.com.
Cytovance, your responsive, reliable, and resourceful partner.