Search results for " pharmaceutical"
Article
What's in Your SOP?
Whether you work in the medical device, pharmaceutical, or bio-technology industry, you are relying on SOPs to help you perform the day-to-day activities associated with your job. The purpose of an SO…
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Reliability Rooms and the Move to Proactive Supply Chain Management
This article discusses efforts that have been underway at Janssen Pharmaceuticals for the past few years to help achieve these goals. Corporate leaders wished to create a program with a transparent st…
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Platform Technologies Improve Protein Expression
…ake protein-based drugs with appropriate post-translational modifications that meet the needs of the pharmaceutical industry, physicians, and ultimately patients in need of novel medications,” notes …
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Avoiding Investigational Failures and Discrepancies
As referenced in FDA’s Quality Systems Approach to Pharmaceutical CGMP Regulations guidance, an “investigation” refers to the formal procedural process evaluation of a problem resolution (2). The Form…
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The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment.
By Jennifer Markarian
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Unifying Continuous Biomanufacturing Operations
Lawrence Yu, PhD, deputy director in the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research (CDER), said in a 2016 FDA blog post that processes that take a month with fed-…
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Fusion Proteins Pose Manufacturability Challenges
Solutions for overcoming these issues are being developed in academia and the pharmaceutical industry by equipment vendors and drug companies alike.
Making proteins ‘druggable’
Many proteins…
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Critical Quality Attributes Challenge Biologics Development
…ibb and Finance Committee member and past-chair of the BIOTEC Section at the American Association of Pharmaceutical Scientists (AAPS), about how CQAs for biologics differ from CQAs for small-molecule…
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Ensuring the Biological Integrity of Raw Materials
It has only been used by a few pharmaceutical production facilities as yet, according to Michael Sasges, a research engineer at Trojan Technologies. “It’s a conservative and highly regulated industry,…
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Last year also marked a significant step towards integrating continuous manufacturing into pharmaceutical production for a small-molecule drug when FDA approved, for the first time, a manufacturer’s c…