Lykan Bioscience will expand its plant in Hopkinton, Massachusetts to support the growing demand for cell therapy development and production.
Lykan Bioscience, a contract development manufacturing organization (CDMO) focused on cell-based therapies, will add seven cleanrooms with capabilities for autologous and allogenic production at its Hopkinton plant.
‚ÄúThe demand in the cell therapy segment is robust, we brought the original 8 cGMP suites online in January of this year and we believe the original capacity will be fully allocated to partner projects in 2022 so bringing these additional 7 suites online in Q4 2022 will be timely,‚ÄĚ Lykan CEO Pat Lucy told BioProcess Insider.
According to the firm, the seven ISO 7 manufacturing suites will meet US Food and Drug Administration (FDA) regulatory guidelines for US clinical and commercial production and three of the suites will also meet European Medicines Agency (EMEA) guidelines for EU commercial production.
The additional seven cleanrooms take the total number of clinical and commercial manufacturing suites to 15 at the site.
The expansion will also include a 1,700 square-foot laboratory located within the plant, which will be used to support partner programs, beta testing, and co-developing cell therapy production and analytical technologies.
This laboratory expansion is anticipated to be commissioned and fully operational for customer projects by Q4 2021.
To service the expansion, Lucy confirmed staff will be added across all groups in the company but said it will ‚Äúnot disclose specific numbers.‚ÄĚ
No financial details have been disclosed either but ‚Äúgiven that the expansion is within the footprint of the existing facility it will be financially efficient and the timeline to commissioning will be abbreviated,‚ÄĚ said Lucy.