By Miriam Monge
There are many new challenges facing those involved in the manufacture of biopharmaceuticals. Whereas in the past, overall process efficiency was sometimes treated as an afterthought as companies tried to get to market as quickly as possible, the production costs of biophar-maceuticals are now, receiving greater attention which is spurring interest in continuous bioprocessing. The loss of patent protection from blockbuster drugs is creating a market for biosimilars in which being able to compete effectively requires low prices underpinned by low manufacturing costs.
Enhanced flexibility and reduced operating costs are being achieved through the widespread adoption of single-use technology either as part of completely single-use processes or as hybrid solutions. However, questions around suitable stan-dards for product contact plastics continue to be debated within industry forums. Greater assurance can be provided to regulators that products are manufactured by well controlled and characterized processes due to advances in process analytical technologies and enhanced QbD regulatory submissions.