Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
News|Articles|May 15, 2017
- Pharmaceutical Technology-05-15-2017
- Volume 2017 eBook
- Issue 1
Getting Biopharmaceutical Tech Transfer Right the First Time
Author(s)Agnes Shanley
Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
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Biopharmaceutical experts Stephen Perry, CEO of Kymanox, James Blackwell, principal consultant with The Windshire Group, and consultant Mike Ultee, share best practices and musts to avoid in biopharmaceutical technology transfer.
Some crucial takeaways? Share all data (especially data on failed runs in the past), and include clear instructions for sampling. In addition, aim for reproducibility.
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Articles in this issue
over 9 years ago
Clean, Disinfect, and Validateover 9 years ago
Kill the Bioburden, Not the Biological Indicatorover 9 years ago
Ensuring the Biological Integrity of Raw Materialsover 9 years ago
Case Study: Retrofitting Two New High-Purity Water Systemsover 9 years ago
Single-Use Bioreactors Have Reached the Big Timeover 9 years ago
Parallel Processingover 9 years ago
Cost Considerations Drive Lean Technology in BiomanufacturingAdvertisement
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Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
The agency issued a direct final rule that supports the use of innovative testing methods to limit the use of animals and maintain existing safety standards.
The FDA approves Inluriyo-Verzenio combo for ESR1-mutated breast cancer; EMBER-3 data double PFS, with supply chain and diagnostics implications for manufacturers.
The Leadership Summit will bring senior pharma executives together to discuss supply chain resilience, medicine security, and manufacturing capacity amid growing geopolitical fragmentation.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
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