iBio launched its first current good manufacturing practice (cGMP) sterile fill-finish capabilities. The services have been designed to move clients with preclinical and clinical stage programs for pharmaceutical products, such as monoclonal antibodies, viral vectors, and other biologics, into the clinic and onto the market faster.
The fill-finish operations from the plant-based biopharmaceutical contract development and manufacturing organization (CDMO) will be housed in its 135,000 square-foot facility in Bryan, Texas. The sterile liquid fill-finish capability will combine in-line labeling to enable the serialization of vials during filling.
iBio said the initial capacity will support between 100 to 2,500 vials runs but the company is already able to produce 15,000 vials per shift at a capacity of 5ml fill volume.
Nicolas Taquet, VP of biopharmaceutical manufacturing at iBio, explained that the company has been preparing for this expansion and will deploy a strategy that uses pre-fabricated cleanroom pods which can readily scale operations and add capacity directly to the allocated space in the facility.
He added that the company plans on adding an additional M&O Perry filler within a pre-fabricated cleanroom pod to double its capacity.
Launching this service comes directly from the growing need for fill-finish capabilities for biologics, according to Taquet.
He said, “Our clients were asking for help given that many are facing long lead times and high costs for certain product types – like viral vectors – or for small runs like early stage clinical and orphan drug trials.”
“Debottlenecking fill-finish is complementary to iBio’s plant-based platform for protein expression and glycan engineering capability. Now, we can fill for clients as well, and help them get to trials, and ultimately to market faster,” Taquet concluded.