Vial Containment Solutions

Gene therapies are developed by modifying a person’s genes and are often targeted to treat complex and chronic diseases. Due to advancements in science and research, gene therapy is positioned to transform treatment options for patients who are living with these incurable diseases. There is a growing pipeline of gene therapies globally, with 352 global trials underway at the end of 2019, up 12% from 2017.^1.

Gene therapies are stored and shipped at ultra-low temperature (approximately -80^oC, either in a refrigerator or on dry ice). This provides a challenge to the primary package systems in maintaining container closure integrity (CCI), especially systems comprising glass vials and elastomer stoppers. These materials have different coefficients of thermal expansion. Upon cooling from room temperature to ultra-low temperature, they contract at different rates; this may lead to gaps and CCI loss.

Regulatory agencies are driving the pharmaceutical industry to continuously improve the quality of drug products, but what is the reality for a drug developer who is expected to make parenteral preparations “practically free from particles”? Expectations of packaging are changing fast but how well prepared is the packaging to meet these needs?

A good elastomer stopper for a vial container system needs to have the right properties. These properties are largely determined by the elastomer formulation, which comprises the base elastomer, fillers, plasticizers, and curing agents. The interplay among these components is crucial, as they determine performance. For example, hardness is affected by filler type and level, as well as by curing agent and level. West understands these issues, and therefore is able to develop formulations to offer maximum performance. An example is the formulation 4040/40, which was designed according to quality-by-design (QbD) principles.

West is pleased to announce that we’ve recently expanded our Online Store offerings to include a 20mm NovaPure^® Ready Pack™ lyophilization stopper, adaptiQ^® vials from SCHOTT and Ready Pack™ Flip-Off^® CCS (Clean, Certified, Sterilized) seals. West’s Online Store is a one-stop solution for access to small quantities of some of West’s highest quality products, in stock and available ready-to-use in convenient small packs. Depending on their product needs, shoppers can now purchase a complete vial containment system with the option of selecting either Daikyo Crystal Zenith^® or adaptiQ glass vials.

“Choosing the Right Components for Container Closure Systems,” the second part of our “How to Qualify Container Closure Systems” series, was recently published in the International Journal of Pharmaceutical Compounding. The article addresses ways in which packaging component selection is critical to ensuring that the closure container system will protect and maintain compounded drug quality.¹