For the third time, this forum explored the topic of quality by design QbD for biologics. The first such forum was held in July and focused on establishing a general understanding of QbD terminology and concepts. In July , the second discussed approaches for submission of QbD data and associated regulatory implications. The pilot program is still in its early stages but nonetheless provides concrete examples of the types of exchange of ideas between sponsors and regulators. The case study on applying QbD principles in development of a monoclonal antibody represents the culmination of a two-year effort by a consortium of biotechnology companies collectively known as the CMC-Biotech Working Group. Find it online at www.
BIO Releases Largest Study Ever on Clinical Development Success Rates | BIO
Host-cell proteins HCPs constitute a significant class of process-related impurities during biologics manufacturing. Due to their potential impact on product quality and efficacy as well as patient safety, the total amount of residual HCP in a biological drug substance generally is considered a critical quality attribute CQA that usually needs to be tested for during batch release 1 , 2. However, the complexity and diversity of residual HCP composition in drug substances and limited knowledge publicly available on the biological, physiological, pharmacological, and toxicological effect of individual HCPs detected in biologics create significant challenges. The main difficulty is in effectively determining at what level — and more important, for which specific HCPs — they could be considered safe or low risk. The industry applies HCP specification limits based on experience, process capabilities, clinical development stages, and HCP testing results from sensitive immunoassays supplemented with HCP characterization by orthogonal methods 5 — 7. However, little to no guidance is available on how to manage HCP-related risks throughout drug substance development. Certain risks can be controlled during cell line and upstream process development if they are known.
Quality by design approach for viral clearance by protein a chromatography
Focus: Improve quality assurance and pharmaceutical development, registration, manufacturing and controls that can support convergence and harmonization of global regulatory expectations for continuous manufacturing. Focus: Develop a body of knowledge around the practice of knowledge management for the pharmaceutical industry. Focus: address challenges that chemistry, manufacturing, and control CMC development teams may encounter when a project is given accelerated development status. Focus: develop an industry-specific maturity model that can help companies design a robust process-capability program and benchmark against their peers. Good Practice Guides provide information on global solutions to implementation challenges of ICH guidances.
Citation: Daniel Borchert, Diego A. Suarez-Zuluaga, Yvonne E. Thomassen, Christoph Herwig. Risk assessment and integrated process modeling—an improved QbD approach for the development of the bioprocess control strategy[J].
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