At the Bioprocess International Conference in Long Beach, California last week, one highlight of the November 2 plenary program was an overview of the Roche-Genentech merger by Tim Moore, Roche's senior vice president of pharm tech operations for biologics.
One could say that supply chain security is the most critical issue facing drug manufacturers today—and perhaps facing our healthcare system as well. The supply chain is at the heart of healthcare’s greatest problems—drug counterfeiting and adulteration, shortages of key medicines, and of course escalating medical costs.
The anonymous blogger Chemjobber has been plying his trade as a writer for the past several years. By day, he is a process chemist at an unnamed drug/chemical manufacturer. “I'm anonymous because 'who I am' is really a distraction and it's not very interesting,” he says.
A few weeks ago, SmithKline Beecham’s Worthing West Sussex, U.K., site received an FDA warning letter related to, primarily, alleged failure to ensure microbiological contamination of products manufactured there. The site was inspected last March, and in April the Agency said that GSK's response to initial concerns lacked sufficient corrective actions.
A speaker at last week’s AIChE annual meeting joked about the nitty-gritty, technical nature of the conference’s Quality by Design topical track. QbD talks at some shows are a bit like Las Vegas, he said—more superficial than substantial—whereas at AIChE they were “more like M.I.T.”
In September, FDA sent a warning letter to Sichuan Pharmaceutical Co., an API manufacturer in China. The letter cited the manufacturer's failure to adequately guard against potential product cross-contamination:
The passing of Steve Jobs has been an opportunity for just about everyone (okay, maybe everyone) to assess his significance and ponder the lessons he taught. Blogs (like this one) seem to see it as an obligation to weigh in.
Bayer and its workers in Berkeley, California, are embroiled in protracted contract negotiations. Last week, we heard from Craig Merrilees, spokesman for the International Longshore & Warehouse Union (ILWU), which represents the workers. Bayer owes workers and the community more, said Merrilees, and worker patience with the company is “wearing...
The contentious negotiations between Bayer and the 400 or so unionized workers at its Berkeley, California biotech facility have become a test case for whether workers in pharma/biopharma (and other industries) have any leverage whatsoever in the face of potential or expected downsizing and outsourcing.
A newly published article in the Journal of Pediatrics calls attention to the increasing numbers of children who are poisoned each year by accidentally ingesting medication not intended for them. More and more kids, the authors find, are winding up in emergency rooms after accidentally taking pills prescribed for their...