Search results for "GMP" in Articles / App Notes
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GMP Challenges for Advanced Therapy Medicinal Products
By Sean Milmo
A consultation period on GMP guidelines (1) in the European Union, specifically for advanced therapy medicinal products (ATMPs), comprising gene- and cell-therapy products and tissue-…
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Applying GMPs in Stages of Development
I always struggle with knowing which level of current good manufacturing practices (cGMPs) apply to different development stages. Can you provide some guidance on this point?
A. In …
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Applying GMPs to the BioPharma Supply Chain
Good manufacturing practices
Suppliers of raw materials need to understand what GMPs mean as they apply to the biopharmaceutical industry. Suppliers need to have a system for assuring the quality …
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Step Up to GMP Manufacturing or Outsource to a CDMO: Considerations and Tips
Whether you are developing a new monoclonal antibody (mAb), cell therapy, gene therapy, or large-molecule biologic drug, the decision to tackle GMP manufacturing in-house or work with a contract devel…
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Start With the End in Mind: GMP Tech Transfer
How can you be one step ahead in process development and prepare for future GMP work?
Hear what tech transfer experts have to say about this important issue in this blog. And, learn how to apply …
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Democratizing GMP Manufacturing for the New Therapeutic Pipeline
PharmTech Europe discusses technology that enables the “democratization” of mRNA manufacturing with Scott Ripley, general manager, Nucleic Acid Therapeutics and Precision Nanosystems, Cytiva, …
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Challenges of scaling up buffer production for GMP and how to evaluate different solutions
This virtual workshop presents different options for scaling up buffer production. You will learn at what scale does it make sense to outsource your buffer production or invest in a hardw…
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The GMP of AAV: Purification for Clinical Production
Watch this presentation to learn about the key considerations when developing a purification process for adeno-associated viruses (AAV).
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Good Manufacturing Practices: Challenges with Compliance
…nd manufacturing organizations (CDMOs) face when adhering to current good manufacturing practices (CGMPs).
Obstacles to compliance
BioPharm: What challenges do you see in complying with FDA’…
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Gowning Practices Provide Clues to cGMP Compliance
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMPs). Quality must be built into the design of a facility to ensure that drugs are manuf…