Search results for " CGMP" in Articles / App Notes
Article
Unifying Continuous Biomanufacturing Operations
Integrated continuous bioprocessing is already regularly being achieved in small research labs, according to Bonham-Carter, but has not yet made its mark in commercial, cGMP environments (8).
Pr…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
The facilities, built in partnership with Cytiva, offer cGMP manufacturing based on mammalian cell culture technologies to meet customer demand for Phase II/III clinical trials. In addition, the singl…
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Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
The agency launched an initiative in 2002 entitled Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach. One of the main goals of the 2002 initiative is encouraging new technology advances…
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GMP Challenges for Advanced Therapy Medicinal Products
56: Application of Phase-Appropriate Quality Systems and CGMP for the Development of Therapeutic Protein Drug Substance (Bethesda, US, 2012).
About the author:
Sean Milmo is a freelance write…
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Modular Manufacturing Platforms for Biologics
The continuous processing skid was prefabricated in Belgium, integrated into a portable cGMP pod that had been prefabricated in College Station, TX, and then re-assembled into Pfizer’s gray warehouse …
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Continuous Manufacturing: A Changing Processing Paradigm
FDA support for quality improvements
FDA has been a strong supporter of continuous processing as early as 2004 when it released Pharmaceutical cGMPs for the 21st Century–A Risk-Based Approach. In …
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Challenges and Trends in Biopharma Facility Design
We have designed a turnkey modular factory, KUBio, which offers a monoclonal antibody manufacturing factory within 14-18 months and is pre-designed to support achieving cGMP requirements.
For biop…
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Raw Material Variability
Aligning supplier capabilities to end user and regulatory requirements will increasingly necessitate ‘pharma standard’ attitudes and cGMP operations for second- and third-tier suppliers, whereas only …
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Outsourcing Trends in Biopharmaceutical Manufacturing
It’s true that these regions have yet to provide the institutional knowledge, facilities, and quality systems to compete in terms of commercial cGMP manufacturing infrastructure, and they have yet to …