Search results for " GMP"

Article 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-…

Article Applying GMPs in Stages of Development
Some of these relationships can be complex, so it is important for every organization involved in the drug development process to be familiar with what the applicable GMPs are and at which stage of th…

Article 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 …

Article 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…

Article 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 …

Webcast The GMP of AAV: Purification for Clinical Production
What should you consider when developing a purification process for adeno-associated viruses (AAV)? We’ll share some insights on that topic. And we’ll discuss ways to overcome the key challenges in …

Article 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).  >>> Learn more

Article Good Manufacturing Practices: Challenges with Compliance
…nufacturing? Smith (Catalent): In general, it is not difficult to comply with the FDA’s GMP regulations, but there are some nuances that can present a challenge. For example, it is straightforw…

Article Gowning Practices Provide Clues to cGMP Compliance
Quality must be built into the design of a facility to ensure that drugs are manufactured under conditions and practices required by the GMP regulations. This concept is broadly embraced across the gl…

Article Viral Clearance Challenges in Bioprocessing
GLP and/or GMP? Viral clearance studies, when performed by contract research organizations (CROs), are frequently performed following good laboratory practices (GLP) principles. Recently, however, …

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