Improving drug delivery is an important consideration in new drug development and in managing the product life cycle of existing drugs. Delivery mechanisms that can improve patient compliance, facilitate administration, and target delivery of an active are crucial goals. Drugs that are delivered topically provide an opportunity to realize these objectives, and an upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »

Economically motivated adulteration became a major concern after heparin manufactured by Baxter Healthcare was contaminated with oversulfated chondroitin sulfate. FDA told the Government Accountability Office (GAO) that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Companies have been reluctant to share this information, but a GAO report suggests a possible solution. Read more »

On November 20–21, I had the honour of being Chairman at the Sterile Manufacturing Dialogue in Old Windsor, England. Despite a very foggy Sunday night and concern that European speakers and delegates would be delayed (many were forced to land at Gatwick airport rather than Heathrow), a healthy turn out early on Monday morning proved the worries to be unfounded.

After I kick-started the conference with a few choice words, notably the idea that many of those present would be unlikely to let me into their kitchens, let alone their sterile manufacturing facilities, the main event began. Read more »

Fujifilm took another step in its strategy of building its biosimilars business with the announcement this week that it had reached an agreement with the biopharmaceutical company Kyowa Hakko Kiron to form a 50–50 joint venture for biosimilars. The move is the latest by Fujifilm, begun earlier this year with the acquisition of the former Merck Biomanufacturing Network, to position itself in the biosimilars market. Read more »

When only a handful of manufacturers supply a given drug, production problems at any of those companies can lead to a shortage. Earlier this year, problems at Ben Venue’s Bedford, Ohio, site contributed to shortages of the cancer drug Doxil. The shortages are likely to continue now that Ben Venue has suspended manufacturing at the plant. Read more »

FDA Commissioner Margaret Hamburg held a special press briefing this morning on Genentech’s Avastin drug and its indications for metastatic breast cancer. She announced that the agency is revoking that indication based on FDA follow-up studies which did not show promising results. Read more »

Come early next week I will be fully ensconced in deep discussions over cleanroom environments, microbial monitoring and single-use technologies in the beautiful setting of Old Windsor in England. I may also possibly take afternoon tea with the Queen in her castle, if discussions finish early. Read more »

Geron announced earlier this week that it was discontinuing its clinical trial evaluating the use of embryonic stem cells for the treatment of spinal cord injury. The company said it planned to discontinue its embryonic stem cell research program, and focus instead on its oncology pipeline. The reason given was economic. According to the company press release, “The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets.” In other words, the company did not expect to recover enough revenue soon enough from the therapy to justify the expense of the remaining trials and the expense of continuing development. Read more »

Biopharmaceutical characterization—especially of unknowns—is becoming far more complex and far higher on the regulators’ radar.  Of particular interest for industry is compliance with harmonized guidelines that address FDA’s concept of a “well-characterized biological product,” which involves being able to measure and control the product’s identity, purity, impurities, potency, and concentration. Read more »

Topical drugs are an important sector in the pharmaceutical market, particularly as pharmaceutical companies seek innovative ways to improve drug delivery and patient compliance. An upcoming webcast on Dec. 7th by Pharmaceutical Technology gains insight from leading industry experts on how to optimize topical drug formulations and manufacturing. Read more »