Pall Biotech, a unit of Pall Corporation, will provide the partnership with access to its single-use stirred tank bioreactor, Allegro, for good manufacturing practice (GMP) manufacturing. Aetos will bring its cell lines and scalable manufacturing processes.
Together, the companies will provide access to integrated solutions to expedite development of biosimilars.
Matt Niloff, director of sales at Pall Biotech, told us that the company has been working to streamline its business model in an aim to enable all types of drug manufacturers to improve bioprocesses. Niloff stated that Pall’s technologies will enable the “next-generation of drug manufacturing.”
He further explained that partnerships like the one between Pall and Aetos “help to highlight the versatility of our technologies to enable both novel and biosimilar manufacturing.”
“Ultimately, this saves the customer time and money, while getting to market faster, which is often critically important with biosimilars,” he concluded.
Biosimilars have become an important part of the pharmaceutical industry as the drugs provide a lower-cost option to biologic treatments. We’ve reported that biosimilars for costly treatments like Humira have been approved by the US Food and Drug Administration (FDA) but are not yet being sold in the US.
However, in Europe biosimilars have been adopted. The European Medicines Agency (EMA) does not regulate therapeutic interchangeability and substitution, so member states and health authorities determine whether or not products can be marketed.
For instance, in Europe, biosimilars of Remicade (infliximab) have been available since 2013. MSD (known as Merck in North America) holds the marketing rights to the originator drug and has seen a drop in sales since the release of biosimilars to Remicade, according to 2017 figures, were launched and marketed in Europe.