Manufacturers are redesigning their processes to balance both better future emergency vaccine mobilization and the more demanding work of maintaining flexible, commercially viable manufacturing networks.
As the urgency of COVID-19 has receded, pandemic preparedness is moving from emergency mobilization to maintenance mode. While manufacturers have an eye on better future emergency preparedness, the higher aim is to convert crisis-era readiness into a commercially sustainable service.
A spate of recent news indicates application of COVID-era lessons into an active manufacturing, policy and commercial agenda benefiting both a more robust crisis response network, as well as commercial capabilities.
Capability build-up
One year after its launch, SPEEDCELL, a project coordinated by the Spanish biopharma HIPRA and co-funded by the EU, announced in late July it had completed its first year of activity. SPEEDCELL is intended to support the development and production of biologics for faster response to health emergencies.
Ultimately though SPEEDCELL’s goal is to have a development and manufacturing platform with possible applications beyond emergency scenarios, particularly routine vaccine and biologics programs, wrote Marc Biarnés, SPEEDCELL project manager and research and development manager at HIPRA Human Health, in an email.
The HIPRA update followed a February press release from the Coalition for Epidemic Preparedness Innovations (CEPI) on a new plan to “transform the way the world tackles the most dangerous viral threats.” As part of the CEPI plan, the organization said it “will accelerate the development of platform technologies and embed them with regional manufacturers so that countries can move quickly against outbreaks,” according to the release.
In tandem with regulator collaboration, “this approach will enable rapid vaccine development, faster manufacturing scale-up, rapid regulatory assessment of candidate vaccines and greater equity from the start.”
On the EU regulatory front, the European Commission, through DG Health Emergency Preparedness and Response (HERA) issued a statement 9 September on the issuance of a Handbook for EU Crisis Procurement of Medical Countermeasures. HERA carries out mapping and monitoring of supply chains, manufacturing capacities and production sites in advance of future health emergencies.
Post-pandemic lessons learned
The COVID-19 pandemic demonstrated that minimal manufacturing capacity cannot lead to a rapid vaccine response without transferable processes, specialized personnel, reliable materials and coordinated supply networks.
Ultimately, COVID-19 pushed CDMOs to become more flexible, supply-chain-aware and ensure streamlined operations beyond the pandemic, said panelists at a BioProcess International conference several years ago. Those gains depend on regulatory support, regional manufacturing and sustainable capacity use.
“The lessons learned across the industry have reinforced the importance of resilient manufacturing networks and trusted partnerships,” said Guy Rachmuth, senior vice president and global head of Strategic BD and Partnerships, at CDMO Just-Evotec Biologics. “Sponsors are increasingly focused on working with CDMOs that can deliver consistently and adapt to evolving program needs.”
An important takeaway from COVID-19 is that sustainable pandemic preparedness mandates “manufacturing capacity to remain economically and operationally viable between emergencies through commercial production, procurement commitments, reserved capacity or other support mechanisms,” noted the Pharma’s Almanac.
The industry continues to balance the need for flexibility with the realities of maintaining highly specialized manufacturing infrastructure, Rachmuth said. “Success often comes from building adaptable processes, experienced teams and scalable operations,” he added.
COVID-19 also taught CDMOs that the pandemic’s speedy development practices can carry over to routine biologics programs without compromising quality or compliance.
HIPRA initiative
“Rather than designing a process around a single product, we are working on a modular approach that can be reused across different programs and has the objective of shortening the path from a new biological target to a manufacturable product,” Biarnés wrote.
During its first year, SPEEDCELL established the technological and operational foundations needed to accelerate the development of biologics. These responsibilities included the commissioning of critical pieces of equipment, establishing two dedicated laboratories and supporting work across gene synthesis, cell-engineering technologies, cell-line and upstream process development.
As HIPRA begins integrating the project’s cell-line and process-development technologies, its CDMO arm HIPRA Biotech Services could provide the route to external customers. But the platform must first demonstrate that it can deliver a measurable reduction in the time from sequence to manufacturing-ready biologic.
“In practical terms, our work addresses the journey from sequence through gene synthesis, cell-line development and process development, ultimately enabling manufacturing,” Biarnés wrote.
SPEEDCELL’s work comes as cell-line development increasingly becomes an important lever for biologics manufacturers, affecting not only product yield but also the ease of process scale-up and technology transfer.
As noted in BioSpace’s Denatured podcast, the field has advanced from CHO cell engineering to targeted integration and transposase platforms.
Cell-line development can be a crucial differentiator, particularly when it drives higher productivity and manufacturing efficiency, Rachmuth said.
Going forward, a rapid-response platform goes beyond speed, Rachmuth said. “It’s the combination of a proven platform, experienced scientists and the ability to efficiently adapt processes to a manufacturing environment,” he added.
