Cambrex Corporation announced that it is constructing a new facility to accommodate four cGMP suites dedicated to cell therapy manufacturing. The expansion will increase the Company's manufacturing capacity by 100%.
The facility and the first two suites are expected to be completed and validated by December 2003. The Cambrex Board of Directors approved the capital expansion in support of the Company's continued commitment to the rapidly growing cell therapy market. Cell therapy is the prevention or treatment of human disease by the administration of cells that have been selected, multiplied and pharmacologically altered outside the body.
Cambrex recently signed a Term Sheet with Ortec International for the commercial manufacture of its tissue-engineered product, OrCel. The tissue-engineered product has been approved by the FDA for use in the treatment of donor sites in burn patients. Currently, Ortec is concluding a pivotal trial for venous ulcers and is expecting to obtain FDA approval and commercialize the product for that indication in 2004. Ortec also intends to seek FDA approval of the product for the treatment of diabetic ulcers. A formal commercial manufacturing agreement is being negotiated. With the execution of the Term Sheet, all of Cambrex's current capacity was completely reserved.
"Cambrex is committed to the rapidly growing cell therapy market. Our experience in human cell expansion and support services along with our dedication to regulatory compliance and patient safety has enabled us to successfully support our clients with clinical and approved therapeutics," said N. David Eansor, President Bioproducts Business Unit.
In early 2001, Cambrex announced the launch of its Cell Therapy Services. Since its introduction, the Company has provided cell therapy services to numerous clients with cell-based therapeutics in clinical trials. Cambrex cell therapy services include human cell expansion, assay development, media optimization and supply, process development, regulatory consulting, release testing, and endotoxin detection.
The current market for contract cell therapy services is approximately $20 million and is expected to grow ten-fold by 2006.