September 16th 2025
Engineered biosynthetic pathways provide new avenues for accessing complex molecules.
September 15th 2025
September 11th 2025
September 11th 2025
FDA Approves Expanded Adjuvant Indications for Herceptin
May 23rd 2008US Food and Drug Administration's Division of Biologic Oncology Products has approved two new biologics license application (BLA) supplements expanding the approval of Genentech's Herceptin (trastuzumab) for the treatment of breast cancer.
An Underfunded FDA Fights Back
May 1st 2008The FDA is under attack from all sides. Many influential members of Congress either don't trust the agency to monitor the industry appropriately, or have found it politically expedient to keep sounding alarms about inadequate oversight of food and drug safety and clinical research. The good news is that there seems to be a growing consensus that FDA needs a major infusion of cash to regain its stature as an effective science-based regulatory agency.
Managing the Global Supply Chain
May 1st 2008Recent problems with food and pharmaceutical ingredients sourced from China highlight a major disadvantage of our complex international supply chains for food and drug ingredients. A global supply chain offers more opportunities for accidental contamination as well as intentional adulteration and counterfeiting. Sticking to minimal requirements may not be enough.
Optimizing the Primary Recovery Step in Nonaffinity Purification Schemes for HuMAbs
An alternative approach to traditional Protein A schemes is comparable in overall efficiency, product recovery, and quality.