A Spotlight on Vaccine Production
January 6, 2021
Co-authored by Rachel Legmann and Byron Rees.
Even though vaccines have been used since Edward Jenner first experimented with smallpox in the 1790s, there are still many challenges in their production. Lower profit margins have become associated with vaccines over the past few decades, and many drug developers shifted their focus to more lucrative areas of drug development, leaving these challenges unsolved.
However, 2020 brought change in the form of its own challenge: the COVID-19 pandemic. Any lag or avoidance of overcoming vaccine production challenges has been swept away by the urgency of the pandemic, which is driving an unprecedented level of innovation in the space. Drug manufacturers are more focused than ever on finding robust, reliable processes with the race to a vaccine including a diverse range of next generation manufacturing approaches and end formulations that leverage various antigens and targets.
In this first blog of a two-part series, the team at Pall Biotech overviews the spotlight the COVID-19 pandemic has placed on overcoming vaccine challenges and begins to explore how working with qualified suppliers using validated platform processes and viral vector manufacturing expertise can speed innovation.
COVID-19 Brings Vaccines to the Forefront
It is well known across the industry that vaccines can often take five years or more to research and develop. With the COVID-19 pandemic in full swing across the globe, there has been intense pressure to shorten process development and manufacturing timelines. Using an accelerated, parallel development approach, the industry has come together to bring 73 candidates into Phase 1-3 or limited clinical trials as of November; many of which made progress into clinical trials just six months after the discovery of the disease1.
Among the COVID-19 vaccine contenders, there are more innovative, diverse initiatives than usual. Candidates include traditional inactivated whole-virus, protein sub-units, modern viral vector and genetic technologies.
Still, despite the pressures to rapidly develop vaccine candidates, this remains a change-averse and cautious industry; developers are drawing on past successes and failures as a reference point in this race. And because the industry is so highly regulated, safety and efficacy must remain paramount through development and into clinical trials.
The Product is the Process
As the industry has matured and drug profiles have become more complex and varied, the saying that the “product is the process” has become popular. This saying highlights the basic truth that there cannot be success in drug development (including vaccines and gene therapies) and production without clearly defined and documented processes that meet or exceed regulatory guidelines. The processes must be rigorously characterized, and the consumables must be validated to ensure safety, efficacy, and consistency, with the ability to scale through to commercial phases.
Now more than ever, manufacturers are looking to work with trusted suppliers that have expertise leveraging quality by design (QbD) methodology while building production platforms and single-use consumables. This approach focuses on reliability, consistency, and scalability from early on in process development phases to ultimately increase product quality and efficacy while saving time, money, and resources. Platforms can be leveraged based on existing experience and customized where necessary to support the process being developed and streamline workflows.
Take, for instance, two leading candidates that are leveraging platform processes previously used for vaccine development and production2.
- Inovio’s INO-4800 DNA vaccine using plasmid DNA
- Jenner Institute’s ChAdOx1 vaccine using recombinant viral vectors
These candidates have advanced rapidly because of the existing gene therapy platform knowledge. With newer processes, such as the use of mRNA and self-amplifying RNA vaccines, there is great potential, but these vaccines will generally take longer to get to clinical trials because the platform approach needs to be designed and validated as part of the process.
In some rarer cases, like with Moderna’s mRNA vaccine, the team was able to reconfigure a platform and get into clinical trials in July of 20203. However, this was only feasible by drawing on extensive historical process and platform development expertise.
The Platform Drives the Process
The vaccine work being done across the industry today is invaluable, not only for the COVID-19 pandemic, but for renewing innovation and proactivity, so that we can be better prepared for the next urgent situation that may come along. We see that regardless of the formulation of a vaccine candidate, the platform does ultimately drive the success of the process. It will also impact whether a successful candidate can be scaled-up to meet the billions of doses needed.
If you are interested in learning more about how vaccines are made, join our team for an ongoing webinar series with Biopharm-Asia called “Securing Process Quality with Flexible Manufacturing Solutions” where we provide insight on the vaccine industry today, its globalization and how the cost of a vaccine is assessed. Different types of vaccine production processes, equipment, and activities will be reviewed with examples from Influenza and Inactivated Polio vaccine manufacturing. These are all available on demand for you to watch at your convenience.
Webinar four: Downstream process development for vaccine manufacturing
Co-authored by Rachel Legmann and Byron Rees.
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