The new cGMP facility increases the existing pilot plant’s capacity by 33%, enhancing the CDMO’s scale-up capabilities and adding greater flexibility to cater for small to mid-scale clinical supply and commercial batch production.
The investment included the addition of three new reactor trains at scales of 225L, 500L and 1,360L, which will help the company to meet growing market demand for smaller API batch sizes.
“We’ve experienced significant growth over the past few years and as demand rises, we have taken steps to bolster our offering,” said Kevin Cook, chief executive officer, Sterling Pharma Solutions. “There are a number of increasingly complex products entering the drug pipeline, many of which are intended for smaller patient populations, so the ability to cater for smaller volumes will be essential as we move forward.
“In addition, increasingly our customers are coming to us for an end-to-end API development and manufacturing offering that will allow them to outsource the entire process. The expansion of our pilot plant will increase our scale-up abilities and allow us to cater for additional projects from proof-of-concept through to commercial manufacture.”
The investment will also allow the CDMO to handle potent compounds across a range of equipment scales, complementing the company’s existing offering.