Particulates and B. Cepacia Figured in November Drug Product Recalls
This article was originally published in The Gold Sheet
Executive Summary
More problems with particulates seen in November drug product recalls
You may also be interested in...
Biotechs Urged to Prevent Viral Risks That Cost Genzyme Nearly $300 Million
Biotechs should bite the bullet and invest in media treatment to avoid viral contamination, experts say. They point to last year's temporary shutdown of Genzyme's Allston Landing, Mass., which has cost the company $293 million in added expenses and lost revenues so far, and may have reduced the market for its top product by as much as 20 percent. Genzyme looks to add treatment now, but many others still take their chances. What happened when a mouse virus snuck into Genentech's plant 15 years ago? Genentech added high temperature short time heat sterilization treatment and never caught another virus. How Biomarin expanded on Genentech's approach with added layers of protection, including the use of disposable technology. Tips on how to add heat treatment of media for a commercial product.
McKinsey Survey Highlights Progress, Challenges in Adoption of QbD
Drug manufacturers are adopting QbD but there are exceptions, especially among some generics firms, McKinsey finds in industry survey. The top challenge to further adoption: misalignment between R&D and commercial operations. Second is a lack of belief in the business case. However, the cost turns out to be low and the financial reward high, McKinsey says.
Manufacturers Encouraged to Enhance Clinical Relevance of Quality With QbD
Using QbD to set specs that make a difference to patients is hard but important work, FDA's Woodcock says. Prasugrel, levothyroxine, pallodone examples explored. How to establish a 'work space.' How to make the right correlations.