Coronavirus Covid-19 was first detected in Wuhan, China last December.1 Since then it has spread to multiple countries, sickening tens of thousands and killing almost three hundred.
At present there are no Covid-19 vaccines, although several are being developed, e.g., Janssen, Sanofi Pasteur, and Regeneron have each teamed up with the U.S. Department of Health and Human Services.2, 3, 4 Likewise, Massachusetts-based Moderna sent a batch of candidate vaccine made at its facility in Norwood to the National Institute of Allergy and Infectious Diseases for testing.5
Facility designers are taking the need for rapid response manufacturing into consideration according to Clare Simpson, Phorum Lead, Technology Roadmapping, at BioPhorum, a London-based think tank of execs from large biopharma firms who promote non-competitive manufacturing innovations.
“As everyone is aware with the recent coronavirus outbreak in China, healthcare emergencies can occur suddenly and without warning. Being in a position to respond rapidly and safely in these situations represents some unique challenges” said Simpson, adding that modular bioprocessing systems can help to reduce the time taken to set up manufacturing capacity.
“Introducing standard design concepts can have significant benefits here where modular facilities can be rapidly repurposed or even shipped to areas of need and commissioned quickly through the standardization and widespread adoption of common, robust verification and validation approaches that are understood and accepted by regulators,” he continued. “Common standards for equipment operation will also add flex to the workforce and potentially reduce cycle times to train on production of new product lines.”
Modular technologies can also help biopharma address other challenges. For example, because they are more straightforward to establish than traditional stainless-steel systems, modular platforms can reduce costs.
“Simplifying the production process and introducing reduced capital risk will lead to a real and significant reduction in the cost to produce drug products and that will lead to widespread benefit from reduced payer costs through to wider availability and potentially speed to market,” according to Simpson. “The ability to repurpose facilities is another advantage in contrast to traditional design. “Biopharmaceutical facilities are traditionally capital heavy, purpose-built enterprises that are inherently linked to a single product lifecycle. Subsequent change of purpose often comes with an additional significant investment in time and money. Adopting a modular and mobile approach shifts the emphasis away from such an approach to smaller standardized facilities that can sometimes be built in less than half the time and for significantly lower cost. They are more flexible and reduce the risk burden of a product failure leaving a mothballed facility.”
BioPhorum’s mission is to create an environment where the biopharmaceutical industry can collaborate and accelerate their rate of progress, for the benefit of all, pointed out Simpson.
“We bring manufacturers and suppliers together to work collaboratively and provide a consistent and unified voice to the regulators and broader industry. In setting out a clear and ambitious roadmap, we are working on a set of clear well researched goals and challenges,” she said. “It is not just about what industry should do better but about recognizing how we can collaborate to accelerate acceptance of things that are already possible now and to bring forward innovation that is near to market.”
1. Coronavirus disease 2019 (COVID-19) Situation Report – 35
2. HHS, Janssen Join Forces On Coronavirus Vaccine
3. HHS Engages Sanofi’s Recombinant Technology for 2019 Novel Coronavirus Vaccine
4. HHS, Regeneron Collaborate to Develop 2019-nCoV Treatment
5. Moderna, NIAID Partner on Planned Trial of Coronavirus mRNA Vaccine