Quality Oversight During Sterile Filling Operations
The author reviews operative options for the implementation of a quality oversight and how companies can benefit from this function from a regulatory perspective.
Good Quality Agreements Support Compliance with CGMP
Drug manufacturers can improve use of quality agreements in contract manufacturing.
Gaining Analytical Insight in the Development of Biologics
Contract testing organizations can provide bio/pharma companies with a cost-effective way to adapt to new technologies and regulations.
Contract Services Investment Update
A review of the latest investments in facilities, equipment, and acquisitions by biopharma contract service providers.
Process Validation in Biologics Development
Process validation is an extension of biologics development processes.
Bigger is Better in Samsung's Approach to Biomanufacturing
A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.
Choosing an Analytical Partner in Early Drug Development
Successful outsourcing relationships for early phase analytics in drug development are driven by partnership.
Outsourcing: Does Focus Pay Off?
Research suggests that working with a single contract partner can reduce development time and improve economics.
Avoiding Complete Response Letters
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
