This webinar will focus on current practices in use at Cytovance Biologics as part of product lifecycle management. At times, projects are received with differing amounts of background information and this webinar will discuss control of quality during the various stages of R&D while still maintaining the flexibility necessary for research. There must be dynamic balancing of expectations for quality with the needs of the scientists to understand and characterize the material being produced particularly in R&D.
Even early-stage R&D benefits from a quality mindset and the speaker will discuss ways that the R&D Quality Group supports the programs. Flexibility is key at this stage and R&D quality activities evolve to focus on the needs of the scientists to collect valid data. As the processes and procedures become better established, the amount and types of documentation increase.
R&D Quality activities in the latter phases of research and development are controlled to allow the ultimate assembly of a documentation package to support the clients’ submissions to regulatory bodies. Documentation at this point includes both written procedures used by R&D to produce the material and method transfer reports that support the eventual authoring of scaled up current Good Manufacturing Practice (cGMP) batch records.
The FDA expects that the drug substance used for toxicology and other testing will be representative of the material eventually produced in cGMP Manufacturing. R&D Quality is part of the team reviewing documentation of production and testing. In many cases, clients request GLP testing of the Tox material. Good Laboratory Practices (GLP) testing is a formal prospective test plan administered by R&D Quality and performed by R&D scientists.
The FDA’s expectations for increased focus on quality in R&D are steadily increasing. It is also in clients’ best interests for Cytovance Biologics to use quality systems to deliver dependable data and thereby minimize product delays. Join this free webinar to learn more about quality in R&D processes.
Gregory Svanas, Director of Research and Development Quality, Cytovance Biologics
Greg Svanas brings broad experience in developing diagnostic medical devices in FDA-regulated environments. He has worked in both large and small companies in areas ranging from basic research and proof of concept, to reagent development and transfer to GMP manufacturing. He then led clinical trials of these diagnostic tests and participated in the preparation of submissions to the FDA and other regulatory bodies.
The breadth of experience gained during Svanas’ 30+ years as an industrial biochemist has given him practical experience in establishing materials and processes that can be successfully transferred into a GMP Quality environment. Svanas’ background in analytical testing, statistical design of experiments and protein characterization allows him to evaluate a range of testing results and to improve the successful transfer of R&D production and testing into full GMP environments.
Svanas received BAs in Biology and Chemistry from Austin College and a PhD in Biochemistry from Purdue University. He received his postdoctoral training in the liver transplant program in the Department of Gastroenterology at the University of Pittsburgh Medical School.
Svanas is currently the Director of R&D Quality for Cytovance Biologics, a CDMO in Oklahoma City, OK. In this role he is responsible for equipment calibration, the testing of material under Good Laboratory Practices (GLP), and documentation of late-stage research. These activities are key for the timely transfer of processes between departments with necessary information to ensure that material produced in R&D is representative of the drug to be produced in cGMP Manufacturing.
Who Should Attend?
This webinar will appeal to pharmaceutical and biotechnology professionals as pertaining to:
- CDMOs & CMOs
- Development Scientists
- Regulatory Professionals
- Quality Professionals
What You Will Learn
In this webinar, attendees will learn about:
- The role of R&D in the Regulatory Roadmap for the Product Lifecycle
- The activities that contribute to the quality of material produced in R&D
- Quality activities for different stages of R&D
- The role of GLP testing in late stage R&D
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 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 our 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 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.