Blogs

In 2011, the US FDA issued an advisory regarding the potential formation of glass lamellae in vials containing injectable drugs. This was in response to several drug recalls in 2010-11. The number of glass-related drug recalls has since declined greatly. This no doubt is due to key actions taken by pharmaceutical manufacturers before the drug goes to market, even during the development phases.

West’s Integrated Solutions program brings together all West’s products/services and industry knowledge into customer-focused solutions that Simplify the Journey™. One aspect of Integrated Solutions is wide-ranging analytical services, which includes state-of-the-art container closure integrity (CCI) capabilities. Understanding CCI as it relates to industry expectations, manufacturing, and regulations can be a challenge.

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the first of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.

At the recent CPhI China Conference, we introduced our Integrated Solutions Program to the Asia Pacific Market. The Program is designed to help reduce risk, mitigate regulatory complexity and Simplify the Journey™ from molecule to market for our pharmaceutical partners.

Before an injectable biologic can be formulated and manufactured, an extensive series of pre-formulation checks are necessary to ensure that developers avoid formulating an unstable, non-viable product¹. Developers must determine whether the injectable biologic will break down within the intended formulation or the manufacturing process. The drug must be thermally stable, possibly resistant to oxidation, tolerate variations in light, and other environmental stresses placed on it during manufacturing and packaging.

Since the 2012 New England Compounding Center tragedy that linked a deadly fungal meningitis outbreak to a failure to use current good manufacturing practices (cGMP),¹ compounding pharmacies have faced increasing scrutiny and regulation by the U.S. Food and Drug Administration (FDA). While registering with the FDA is still voluntary, only compounding pharmacies that register, and pass inspection, will be granted “503B” status as compounding outsourcing facilities under Section 503B of the Federal Food, Drug, and Cosmetic Act.²