Breakage and particle problems associated with glass containers and biologic product sensitivities are prompting pharma firms to take a harder look at polymers for their vials and syringes.
Plastic is now more commonly used than glass for injectable products in Japan – reflecting in part the heightened concern there with cosmetic defects and the results of visual inspections.
Drug manufacturers in the US and Europe, in turn, are beginning to more seriously explore plastic containers, particularly in the context of their clinical development programs for biologics. The focus is more on the development side given the challenges of making the conversion from glass for already-marketed injectable products.
As the advancing analytical technology allows for better detection of glass defects, glass/product interactions and the particles they can produce, compliance pressures have increased to minimize these problems or seek alternative containers.
At a two-day PDA/FDA “Glass Quality Conference” in late May in Arlington, Virginia, Amgen Quality VP Martin Van Trieste pointed to the recent upswing in recalls due to glass breakage and particles, and commented on the implications.
“We have glass going through the end-to-end supply chain and clearly not meeting the specs or expectations…. The question is – is that going to force people to think about something else?”
A recent industry survey sponsored by PDA indicates that this may now be happening (IPQ “In the News” August 3). About one-third of the respondents said that they are exploring the use of plastic container alternatives, and half of these have an active evaluation program in place.
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See related stories:
Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions
Industry/Regulator Forums Point to Role of Glass Suppliers in Injectable QbD
USP is Revising its Compendia in Response to Injectable Product Glass Issues and Plastics Usage
Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality
Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny
The series of IPQ stories, which comprises an in-depth report on the current challenges and solutions to glass control for injectable products, can be purchased for $295 by contacting Jonathan Trethowan (Jonathan@ipq.org). Individual stories can be purchased for $95 each.