COVID-19 fostered a spirit of innovation and collaboration that industry must harness to overcome emerging manufacturing challenges, according to officials at Ireland’s National Institute for Bioprocessing Research and Training (NIBRT).

The World Health Organization (WHO) officially designated the SARS-CoV-2 outbreak as a pandemic in March 2020. Just nine months later the first vaccine against the virus–since named Comirnaty–was cleared for emergency use by the FDA.

Days later the Agency granted Moderna’s mRNA-1273 vaccine (now called Spikevax) Emergency Use Authorization (EUA). Since then, hundreds of millions of doses have been manufactured and administered worldwide.

The speed with which Comirnaty and Spikevax were created and produced–vaccines usually take 10 to 15 years to develop according to IFPMA data–shows what can be done when industry innovates, notes Alison Quinn from the NIBRT.

“The biopharma industry has shown remarkable resilience and innovation to respond to the multiple challenges from COVID-19.  In particular, the unprecedented speed to develop highly effective vaccines anti-virals many based on innovative technologies is really a historic achievement,” she says.

“These achievements were underpinned by a very strong collaboration of multiple stakeholders from government, industry, and academia. This deeply rooted collaboration is fundamental to addressing the many healthcare challenges that still remain and will evolve in coming years.”

Manufacturing challenges

And many of these challenges are associated with manufacturing, states Quinn, who says that, prior to COVID-19, drug makers had been slow to adopt innovative production technologies.

“While biopharma manufacturing continues to evolve at a rapid pace, there are multiple challenges still to be addressed to increase operational efficiencies. For example, 4.0 technologies have not yet been deployed extensively throughout the industry, certainly in comparison to other sectors. In particular, the application of data analytics throughout global manufacturing network shows considerable untapped potential.”

Quinn also cites process development as another increasingly difficult area for firms working on advanced therapies.

“As new therapies emerge from the research pipeline, in particular Advanced Therapeutic Medicinal Products (ATMPs), these provide  significant challenges to process development and manufacturing operations to be able to manufacture these therapies at the required scale and efficiencies,” she explains.

“For example, the industry is also seeing capacity constraints in other rapidly developing areas such as plasmid production and viral vector manufacturing.”

Autologous cell therapies are another example, points out Quinn, who says most products of this type are manufactured using highly manual, operator intensive processes.

Collaboration

The pandemic also illustrated the benefits of collaboration and, Quinn continues, underlined the importance of projects like the Biopharma Alliance that NIBRT established with the Boston Consulting Group.

“Since its inception in 2018 the Biopharma Alliance for Industry 4.0 has created an Innovation Centre for Operations (IC) at NIBRT which demonstrates the application of key technologies to over 200 use cases developed by the Alliance industry members, she tells GEN.

“These use cases describe key issues in the biopharma manufacturing process which could be addressed by the application of 4.0 technologies. NIBRT and BCG work with a broad range of technology providers to assess, prototype and demonstrate the effectiveness of their technologies to address these use cases.”