Under the deal FB will undertake process and assay development, as well as manufacture of ACS’ candidate engrafment enhancer ASC-101 at its good manufacturing practices (GMP) accredited facility in Alachua, Florida.
FB spokesperson Chris Aytug told Outsourcing-Pharma that: “This work involves production of [the] enzyme in a serum-free suspension CHO culture. The development involves scale-up and improving feeding strategies for batch culture as well as developing downstream processes and release assays.”
She explained that ASC has asked for “gram quantities” of the drug for upcoming Phase I clinical trials, adding that: “This is well within our capacity, which tops out at 400L in a disposable stirred-tank bioreactor.”
Demand picking up
Aytug went on to say that demand for this type of manufacturing is increasing after the initial shock of the global economic downturn and its impact on pharmaceutical industry spending.
“Things were slow but are picking up now. We see an increasing demand for reasonably priced Phase I/II development and manufacturing, which has supported our decision to increase our cell culture capacity.”
The Floridian firm, which was set up in 2006 as an operating unit of the Center of Excellence for Regenerative Health Biotechnology (CERHB), recently expanded production capacity at its 23,000 sq ft facility.
Pharma funding drives biologics growth
Aytug also predicted that drug industry demand for contract biologics work will benefit those contract manufacturing organisations (CMO) that are flexible enough to help clients develop and execute the best process for their stage of development.
“We believe that the increase in development of biologic therapeutics, both gene/cell and protein based, will continue.
“The most significant factors driving this demand are the positive results and favorable safety profiles associated with many protein therapeutics currently under development and the increasing numbers of large pharmaceutical companies helping to fund these programs.”