Solving the Vaccine Supply Challenge

Published on 2 September 2020

Right now is an exciting time for vaccine science, with an unprecedented level of attention, resources, and testing being directed at the effort to control the COVID-19 pandemic. In this post, we share a new video and provide additional information to explain the role that InVitria’s recombinant human protein products play in accelerating the vaccine development timeline.

The global effort to develop a safe and effective vaccine against COVID-19 is an impressive feat of collective scientific effort and will undoubtedly lead to new insights into vaccine development for a host of other infectious diseases.

There are currently close to 170 different vaccine candidates under study , including seven in phase III pivotal trials, 17 in phase II safety trials, 25 in phase I safety trials, and another 139 in some stage of preclinical development. The approaches are varied and include non-replicating viral vectors, inactivated virus particles, live attenuated virus, protein subunits, protein multivalent virus-like particles, encapsulated RNA, and DNA plasmid vaccines.

While the first candidates to be approved will likely garner international coverage in the news, the true proof of any vaccine development program will be a vaccine that is safe for widespread use, elicits a robust and durable protective response against the SARS-CoV-2 virus within one or just a few doses, prevents transmission, morbidity, and mortality, and is cost-effective to manufacture and distribute globally.

No matter what strategy proves most effective, the vaccine’s components will need to be manufactured quickly and at an enormous scale to ensure doses are available to the world’s population.

Scale-up from research to commercial availability is a challenging process that is often underestimated; however, it is vitally important for safe, rapid and cost-effective vaccine delivery.Traditional platforms for vaccine manufacture, such as in chicken eggs, are unlikely to satisfy the needed production timelines and may be supplanted by recombinant production in HEK293t or VERO cell-culture bioreactors. The success of manufacturing scale-up, in turn, will depend on the availability, reliability, and safety of the raw materials.

As the field of vaccine science is accelerating, there has also been explosive growth in the number of biologic therapies under evaluation for approval.

Cell and gene therapies, in particular, rely on many of the same manufacturing strategies and raw materials as recombinant vaccine production, creating a looming potential bottleneck in the supply chain.

Fetal bovine serum (FBS), typically sourced as a byproduct of the commercial beef industry, is one raw material that has the potential to limit production of needed therapies. Demand for FBS has been steadily growing, with more than 300% price increase in just less than a decade. Unfortunately, given the changes in the market for biologic therapies, this demand is unlikely to abate. Furthermore, the regulatory landscape for products changes as they evolve from R&D to commercial scale-up. As a complex, natural product with a high degree of variability, FBS introduces potential uncertainties into the quality and regulatory process that could delay approvals or alter the composition and safety of the final product.

To realize the goal of protecting the world’s populace with a vaccine against SARS-CoV-2, vaccine manufacturers will need a reliable source of cGMP-grade materials that provide safe and cost-effective alternatives to animal-derived products without sacrificing performance.

InVitria offers a full line of animal-free, recombinant human proteins for supplementation in serum-free, production-scale cell culture and for final vaccine product formulation.

InVitria’s OptiPEAK Complete Media are chemically defined, complete media products specifically tailored to maximize performance, consistency, safety, efficiency, and cost effectiveness of cell-based vaccine manufacture in cell lines such as HEK293t and VERO.

Like all of InVitria’s products, every protein component in OptiPEAK Complete Media is fully recombinant, fully human in sequence, and manufactured in the US, in a tertiary-level, animal component-free, ISO 9001 certified facility. InVitria media and their components do not contain undefined plant hydrolysates, human blood-derived components, or animal-derived components.

OptiPEAK Complete Media have been optimized to promote superior cellular expansion kinetics both in tissue culture and in scalable bioreactor format for clinical and commercial manufacturing.

Advantages to using OptiPEAK Complete Media instead of FBS-supplemented media in the bioreactor include:

• 16% reduction in cell doubling times
• Higher cell density on day of transfection
• More rapid attachment to carriers
• Greater glucose consumption
• Increased reporter gene expression
• Eliminated foaming of media
• Higher linear feed rate

 

InVitria’s Exbumin recombinant human albumin is approved in the US and Europe as a final-formulation excipient to improve viral stability in injectable vaccines and therapeutics.

Exbumin is fully recombinant, fully human in sequence, and manufactured in the US, in a tertiary-level, animal component-free, ISO 9001 certified facility. It is the principal excipient in ERVEBO (Ebola Zaire Vaccine, Live, Merck Sharp & Dohme Corp.), the first vaccine to be approved by the FDA for the prevention of Ebola virus disease. Exbumin has been included in more than 250,000 human injections.

Replacing complex, undefined, serum-derived products with InVitria’s recombinant, animal-free proteins and media supplements can have extensive performance, yield, and safety benefits for vaccine research, clinical development, and commercial-scale biomanufacturing.

If you’re ready to say good-bye to serum for good, we’re here to help. To learn more about transitioning your virus-producing cell culture system to complete, chemically defined, serum-free and animal-free media, contact us or follow this link to InVitria’s Custom Media Formulation services page.