Nine duloxetine recalls since 2024 show why generic drug manufacturers need route-level nitrosamine risk assessment, not end-product testing alone.
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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Ravi Kiran Kaja, PhD, explains how USP’s industry-wide initiative aims to build confidence in trace-level extractables and leachables results.
Science, circularity, regulation, and technology are reshaping how the industry develops packaging for medicines.
The FDA expanded Anktiva to BCG-unresponsive papillary-only NMIBC using existing CIS trial data, a precedent with implications for development timelines and supply planning.
AI accountability, faster FDA pathways, rare disease CMC review, and next-gen GLP-1 formulation lead this week’s PharmTech roundup.
MASH and cardiomyopathy AI collaboration: AstraZeneca pays insitro $40M upfront for target discovery, then leads clinical development and CMC planning.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about rare disease treatment development and navigating the FDA’s Rare Pediatric Disease Priority Review Voucher Program.
NVIDIA’s $250M, five-year compute donation funds UK agentic AI safety research, with implications for how GMP teams validate and govern autonomous AI.
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