The Canadian CDMO has begun formulation development for an ALA-002 50-mg capsule, with GMP production planned for clinical supply.

The acquisition would expand Samsung’s CDMO capabilities into peptide manufacturing, with completion now expected by late 2026 or early 2027.

Bids are being accepted through December 15 for the facility, viral vector manufacturing, equipment, and related intellectual property.

The Raichur campus expansion will add 10 kiloliters of synthesis capacity, with the first commercial production line scheduled to open next month.

The program includes vaccine scale-up and manufacturing by SK bioscience with the company’s CDMO subsidiary, IDT Biologika, responsible for fill-finish operations.

The expanded agreement adds six commercial biologics programs at the CDMO’s Denmark facility to five already assigned to its site in Japan.

The site has finished its first Good Manufacturing Practice batches of drug substance and drug product, advancing its overseas production operations.

The agreement gives Fresenius exclusive access to candidates across 13 therapeutic areas, with development planned over the next decade.