- Lifecore Biomedical signed two CDMO manufacturing agreements with an existing U.S. biopharmaceutical customer, including a commercial site transfer and a service expansion.
- The company will undertake technical transfer and scale-up activities, with potential commercial manufacturing expected following regulatory approval.
Lifecore Biomedical has entered into two contract manufacturing agreements with an existing U.S.-based biopharmaceutical customer, expanding its CDMO operations during DCAT Week. The agreements include a commercial site transfer for a marketed product and an expansion of manufacturing services for another commercial therapy.
Under the first agreement, Lifecore will take over manufacturing of a currently marketed product that has previously been produced by another CDMO. The company will conduct technical transfer activities, including process performance qualification (PPQ) batches at commercial scale. Commercial manufacturing is expected to begin following the completion of regulatory requirements.
The second agreement expands Lifecore’s role in producing an existing ophthalmic therapy. The company already manufactures the product in one format and will now add a second delivery system, which is currently produced in Europe. This development extends Lifecore’s contract manufacturing scope for the same customer.
The agreements form part of Lifecore’s broader commercial strategy, which prioritizes site transfer programs. According to the company, this marks the fourth such agreement signed within the past five months, reflecting continued activity in late-stage and commercial manufacturing programs.
“The commercial site transfer, which is the fourth we’ve signed in the last five months, is a testament to Lifecore’s successful new commercial strategy and our prioritization of such transfer programs, which present a higher probability of approval than earlier stage development programs.”
Paul Josephs, Chief Executive Officer of Lifecore
