By building a roadmap based on cGMP activities that outline the level of scientific understanding, layering in parallel the compliance expectations, the development of control strategies navigates the product to ensure that requirements are met.
TORONTO (PRWEB) March 19, 2020
The speaker will give you a look into how a CDMO navigated an industry anecdote that drove the creation of company policy and the development of the Lifecycle Matrix tool. A holistic approach was used to build a roadmap of product development and regulatory activities based on cGMPS and ICH requirements. The approach was to layer the manufacturing processes and activities with best practices for achieving compliance. As the product development progresses through the phases and then into commercial manufacturing, the regulatory requirements and expectations increase. Using this tool during product development can provide a regulatory strategy map that navigates hurdles prior to regulatory agency reviews.
Taking a proactive approach to exploring what control strategies are expected, and subsequently required, will provide a streamlined development approach ensuring the safety and quality of the product. A phase-appropriate cGMP operating model is highly relevant for companies that have a high level of externalization of their R&D and early investigational development activities. This approach is characterized by an accumulation of product/process knowledge, increasing application of good manufacturing practices, and escalating quality controls across the product lifecycle.
Explore how Cytovance Biologics created and uses this tool to maintain a uniform interpretation of company policies, client processes and global regulations. By building a roadmap based on cGMP activities that outline the level of scientific understanding, layering in parallel the compliance expectations, the development of control strategies navigates the product to ensure that requirements are met.
For more information or to register for this event, visit Phase-Appropriate GMPs: A Regulatory Roadmap.
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 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 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 http://www.cytovance.com.
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