Search results for " pharmaceutical industry"
Article
Biopharma Seeks Balance
Big Pharma spinoffs, startups, virtual companies, industry-academia partnerships, and a growing contract services market contribute to the changing landscape of the pharmaceutical industry.
Glo…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The concept of quality by design (QbD) was introduced to the pharmaceutical industry in the International Conference on Harmonization (ICH) guidance documents, ICH Q8-Q11 (1-4), as a way to develop ro…
Article
Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
Article
Framing Biopharma Success in 2016
…g manufacturers; to improve its ability to predict and mitigate drug shortages; and “encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pha…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Apr 02, 2015
By Jill Wechsler
Pharmaceutical Technology
Volume 39, Issue 4
To ensure patient access to high quality, safe, and effective medicines, FDA spends considerable time and resou…
Article
The Future of Biopharma
What the industry's future holds and what needs to be done to get there.
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation …
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech.
By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…