Search results for " sourcing"
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
FDA Seeks Metrics to Define Drug Quality
Manufacturing standards are considered key to preventing drug recalls and shortages.
Critical drug shortages and contaminated compounding of sterile injectables have heightened public concern a…
Article
Report from India
Pharma industry players brace for challenges as India’s new drug-pricing policy kicks in full gear.
(Dmitry Rukhlenko/Getty Images)
On July 1, India's new…
Article
Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends.
With the dawn of the 2…
Article
The Lifecycle Change of Process Validation and Analytical Testing
In the two years since the publication of FDA's final process validation guidance, how has this new lifecycle approach affected the way the industry performs validation? BioPharm Internati…
Article
The Future of Biopharma
…nts
• 24% analytical methods
• 30% others: product platforms, cost reductions, materials sourcing, supply chain regulatory compliance, biosimilars, etc.
Key Micro-Trends
This rela…
Article
Automated Concentration and Diafiltration of Multiple siRNA Samples
A team of scientists collaborated on a project to transfer a conventional manual concentration/diafiltration process for siRNA production.
ABSTRACT
The use of small-interf…