Daria Donati
Head of Business Development and Strategic Partnerships, Cytiva
COVID-19 has transformed the vaccine development pathway, slashing timelines from years to months. So how have companies compressed their activities without compromising safety?
The race for a COVID-19 vaccine has transformed the drug development pathway in a way that would have been unimaginable just a few short months ago.
Development pathways were significantly reduced, but how has such success been achieved in such a short time frame? And how have drug developers adapted their operations to join the fight? The compression of time meant everyone had to be on board including raw material suppliers, regulatory agencies, shippers.
How are vaccines normally developed?
Usually, the first thing you do when developing a vaccine is study the behaviour of the disease, to identify which part of the pathogen would be to key target in the infectious agent.
You would then think about about the best technology to support the development of a vaccine, and how to start making enough investigational product for clinical trials.
Clinical development and process development tend to run in parallel. Normally, the life cycle of vaccine development takes time.
While the safety trials, Phase one, two, and three trials are ongoing, developers are working concurrently to improve manufacturing processes.
It means that by the time the product is approved to launch, manufacturing scientists know the most robust, effective way to make their product, and have specified and tested the infrastructure needed to start manufacturing at scale.
How is COVID-19 changing this established pattern?
There isn’t time to invent or develop a new technology. The compressed COVID-19 timeline requires new efficiencies in clinical trials. The recruitment process for trials was enhanced with thousands volunteering and quickly ensuring a diverse pool of candidates.
The challenge is building an effective process that compresses the whole development and manufacturing pathway, including scaling up production, without compromising safety.
Safety and quality are at the forefront and these processes must be bulletproof.
How are companies responding to this challenge?
Rather than investigating new technologies, companies are looking at how they can utilise existing vaccine modalities they are already familiar with, such as viral vectors, nanoparticles, RNA or recombinant proteins.
It means that so far, the companies with the most amount of experience and who have already built flexibility into manufacturing to produce multiple therapeutics were at a distinct advantage. Companies poised to transplant manufacturing around the globe due to standardised manufacturing approaches are also better positioned to support COVID-19.
COVID-19 has challenged the industry to be more responsive and develop a cohesive and rapid crisis management approach. Governments are charged to fund local manufacturing needs to ensure a timely response to the healthcare needs in their regions.
How can companies build the knowledge and flexibility they need to compete?
For companies pivoting to vaccine or therapeutic development, our advice is to quickly establish what capabilities you have in-house, identify the gaps, then look to collaborate to compensate gaps, this could be to get access to innovative tools or establish a partnership facilitating access to exclusive materials.
Find organisations that can provide the expertise you need to achieve your goal and ensure that your investments embed as much flexibility into the processes as possible. This could involve production of clinical batches at a CDMO with subsequent transfer to your existing or new facility. For this purpose, it is key to carefully evaluate the risks and benefits of outsourcing versus manufacturing in-house as well as assessing flexible manufacturing platform options.
