A trio of experts speaking at the online industry event this week report near-term capacity constraints for recombinant vector manufacturing, with continuous bioprocessing & process intensification set for rapid growth in the next 5-10 years
Speaking during the virtual CPhI Discover pharma event this week, indicate the COVID-19 pandemic has resulted in positive results for contract development and manufacturing organizations (CDMOs). However, these same industry leaders advise that viral-vector manufacturing could be plagued by shortages in coming months.
During a CPhI Discover session titled Navigating the CDMO Market: Hurdles, Transformation, and Opportunities, three experts shared ways the pandemic has moved CDMOs to change gears, seeing more effective planning, rapid capacity increases, and longer and more strategic contracts than in previous years. The experts include:
- Peter Shapiro, senior director of drugs and business fundamentals with PharmSource, a GlobalData Company
- Eric Langer, president and managing partner for BioPlan Associates
- Kevin Sharp, head of alliance management with Samsung Biologics
Shapiro remarked that while CDMOs have succeeded in seeking and finding rapidly available capacity, this success could lead to shortages in other areas.
“When we look at the rates of outsourcing for the products for COVID-19 given emergency use authorizations, we see 50% of these drugs had an associated contract manufacturing agreement and that includes all of the vaccines that were approved under EUA,” Shapiro said.
However, Shapiro also said that in the future, injectable dose and viral-vector production could experience challenges with capacity going forward—important because these are crucial COVID-19 fighting areas such as cell and gene therapy, as well as recombinant vector vaccines.
“There was already a significant shortage of capacity in this field, and this has been exacerbated by the AstraZeneca and Johnson & Johnson vaccines as well as those from Russia and China,” he added.
Langer said development and manufacturing have seen no significant or dramatic shift, nor has the CDMO market, as a result of the pandemic response; however, activity has accelerated.
“The industry is now seeing more facilities, more modular construction, and greater staff shortages, and that the pandemic has exacerbated short supply of single-use products and devices, an issue that was predominant before the coronavirus outbreak,” Langer said.
Langer also highlighted continuous bioprocessing and process intensification as growth manufacturing strategies, with the pandemic highlighting the need to rapidly respond to a life-threatening situation like the pandemic. All three of the panelists suggested keeping an eye out for contingencies regarding capacities set aside by the government or larger players, in the event of surging demand.
Sharp added, “Within a very short period we saw that capacity dry up; whether it was internal capacity within the pharmaceutical company space or the CDMO industry available capacity and it was really agnostic to scale. Therefore, having flexibility from your CDMO to adjust to growing demand will be essential to maintaining commercial volumes. So, ensuring the long-term availability of required capacity at the CDMO when negotiating a commercial supply agreement is critical.”
The panelists also suggested the industry needs to take a bigger-picture view of things and realize the pandemic is not the only dangerous challenge to be dealt with.
“All the clinical issues that we saw, whether it be in oncology, products being brought to market or the R&D associated with that, it doesn’t go away; people are literally dying as a result of the shift in focus from what had been before to the pandemic,” Langer remarked. “This is a double hit on an industry that’s truly critical to so many people and the fact that we’re seeing it rise to the occasion is a tribute to the people involved in it.”
While the CPhi Discover sessions have concluded for 2021, this and other sessions can be viewed on-demand at www.cphi.com/discover/en/home.html
