Vaccine development differs widely from drug development in many ways, including packaging, storage and distribution. Primary packaging plays a critical role in the stability of vaccines and COVID-19 has created an urgency that disrupts standard evaluation of potential packaging systems.

Fran L. DeGrazio, Chief Scientific Officer at West Pharmaceutical Services discusses why and how vaccine development is different than drug development, and the nuances of vaccine development in the current landscape regarding COVID-19. –KB  

Contract Pharma: How does vaccine development differ from drug development? What key distinctions does vaccine development entail?

Fran L. DeGrazio: While overlap exists across certain elements critical to the development process for vaccines and drugs, many key nuances differ between the two. Vaccines in general tend to be more temperature-sensitive, for example, which triggers the need to maintain a secure “cold chain” during storage, handling, and transportation.

Further, the pure scale of vaccine development and production is significantly larger than that of a single new drug – from the number of involved resources to the number of units produced, storage needs, access and beyond.

CP: How is the current landscape regarding COVID-19 impacting vaccine development?

FD: Development and distribution of a vaccine for SARS-CoV-2 presents challenges that are wholly unprecedented and impact the industry at large, as all players – from contract manufacturers to pharmaceutical and biotech companies to clinicians/scientists – must adapt accordingly in order to deliver a safe and effective vaccine as quickly as possible.

First and foremost, there is an unparalleled sense of urgency, given the impact to-date and potential future implications of this pandemic, which is driving vaccine R&D at speeds unlike anything seen even in fast-tracked drug development. And this in turn impacts all aspects of development.

Other challenges being mitigated on the path to discovering a viable vaccine include issues concerning package selection and systems, as well as storage. Typically, selecting a package system for a vaccine platform may not present as many complicating factors – as ample time would be available for evaluation of compatibility with the vaccine. However, for SARS-CoV-2, regardless of whether the vaccine platform being studied and potentially used already exists or is new, these evaluations are being accelerated. This can create varying degrees of added risk.

For example, the selection of vial/stopper primary package systems from manufacturing through delivery is a key consideration in vaccine development. However, specific to SARS-CoV-2, this selection process becomes compounded by expedited timelines, in addition to the fact that various technologies and platforms are being explored – each of which may have different requirements to assure stability, quality and delivery.

An example of this is that typically, primary package systems for vaccines employ glass vials. But, with the increased demand resultant from the SARS-CoV-2 pandemic, potential glass vial shortages and unacceptable lead times, alternatives such as polymer vials may also need to be considered.

CP: How is the COVID-19 pandemic impacting West’s products/services/operations?

FD: We are committed to doing our part to speed the successful development and large-scale manufacture of high-quality components required to serve customer needs for the delivery of a safe and effective SARS-CoV-2 vaccine, which includes expanding labor and equipment resources.

In an effort to best support our customers investigating potential vaccine candidates for SARS-CoV-2, West has made it a practice to preemptively assess needs, evaluate which of our products and services could be most of use and ensure operations are available at needed scale.

For instance, across the six platforms currently being considered for SARS-CoV-2 vaccine candidates, West offers product solutions that may help optimize quality to safety from manufacture through delivery in the midst of compressed timelines. This includes offerings that can mitigate the migration of leachables from and interactions between the closure and the vaccine product, while enabling proven package system container closure integrity. And many of our relevant products are already globally available and market accepted, with options available in varying sizes and configurations – which may help reduce certain risk, since accelerated vaccine development timelines cannot accommodate standard evaluation within potential packaging systems.

As the COVID-19 situation continues to evolve, we remain committed to supporting and delivering for our customers, patients, and employees – while never compromising on safety. Our teams are constantly monitoring to ensure we have the most optimal protocols in place within our operations in accordance with guidance from leading experts, and are working to help minimize the impact of potential logistical and supply challenges that may arise outside of our scope of control.

This also includes capital investments to shore up areas of our robust manufacturing program as needed, as demand for supplies needed for use with treatments to combat COVID-19 has increased across the board – even beyond vaccine development.
 

Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry, with extensive expertise in injectable drug products, including vial container closure systems and prefillable systems for combination products.  Fran has held numerous technical roles at West, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories and Scientific Affairs.  In her current role as Chief Scientific Officer, she is responsible to leverage scientific and regulatory understanding across the enterprise.  Fran received the Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Business Woman’s Association Luminary Award for West in 2017.