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 Challenges of scaling up buffer production for GMP and how to evaluate different solutions
They will be discussing the challenges of scaling up buffer production for GMP manufacturing. They will present different options for scaling up buffer production and lead a discussion on the pros and…

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 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…

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…

Next Page