Selecting Container Closure Components With Confidence: A Data-Driven Approach To Container Closure Integrity

By Bettine Boltres, Director of Scientific Affairs & Technical Solutions, Glass Systems

There are few signs that momentum in the biologics market is set to slow down. Strong pipeline growth and a dominant share of drug approvals by the US Food & Drug Administration (FDA) in recent years points to the sector’s sustained potential for years to come.

Bringing a new drug to market can undoubtedly deliver great rewards for patients and patent-holders alike, but whether in the case of biologics or small molecules, it is an undertaking that also carries well-documented risks. In order to get there as quickly as possible, companies must blend agility, knowledge and resources in the right combination to meet development deadlines and answer the demands of regulatory agencies.

One major potential point of friction on this approval journey is the need to specify and verify a compatible packaging combination for your drug product. Container closure integrity (CCI) is a critical aspect of drug development, and one that demands attention and investment early in the process to avoid complications and possible harm further down the line.

Containment issues during the development phase can also prove costly, with reworking of the system resulting in delays and additional costs. For resource-limited emerging companies, which are the major driving force behind innovation in the biologics market, such challenges add to the already high burden they face in achieving regulatory approval. Indeed, such companies take an average of two years longer to get to market compared with their more established counterparts.

Particularly in the case of emerging companies then, containment can be seen as a key concern. Failure to manage the issue effectively within the development phase has the potential to derail preapproval progress, while it also has the potential to become a major disrupting factor following regulatory approval if containment failings trigger a product recall. In this article, we discuss how West is supporting pharmaceutical partners in this critical area through an efficient, data-driven process that employs innovative methods to accelerate the selection of a closure containment system that meets the requirements of the modern regulatory landscape.