Supplier News: Olon, Kindeva, Stevanato & More
The latest from CDMOs, CMOs, and suppliers featuring Olon, Kindeva Drug Delivery, Stevanato Group, and Cellares.
Chemicals/Chemical API Manufacturing
* Olon Opens HPAPI Mfg Suite in US
Biologics Manufacturing
* Cellares Raises $225 M To Launch New Cell-Therapy Mfg Facility
Formulation Development/Drug Product Manufacturing
* Kindeva Launches Analytical Service Business
Packaging
* Stevanato Launches Small-Batch Lab Fill-Finish Service in US
Chemicals/Chemical API Manufacturing
Olon Opens HPAPI Mfg Suite in US
Olon, a CDMO of active pharmaceutical ingredients (APIs) and intermediates, has announced the construction of a GMP high-potency API (HPAPI) suite at the company’s site in Concord, Ohio.
The company’s Concord site is the company’s Center of Excellence for early development of APIs. The expansion adds to the company’s commercial-scale operations at its sites in Segrate and Rodano, Italy (near Milan).
As additional safety data becomes available, the site can adapt protocols accordingly, allowing scale up for 1-10 µg/m3 OEL (OEB4, SafeBridge 3A) or lower bands into the pilot plant using a continuous liner and a portable filter dryer which is rated to OEB5.
Source: Olon
Biologics Manufacturing
Cellares Raises $225 M To Launch New Cell-Therapy Mfg Facility
Cellares, a South San Francisco, California-based CDMO of cell therapies, has secured $255 million in funding for the launch of an 118,000-square-foot development and commercial-scale manufacturing facility in Bridgewater, New Jersey.
The new facility will be capable of producing 40,000 cell-therapy batches per year and will be cGMP-ready in the second half of 2024 and represent Cellares’s third manufacturing facility in the US. It currently operates two facilities in the US. Cellares’ first facility in South San Francisco, California, is currently being used for preclinical process development and tech transfer of manual processes. Another South San Francisco facility will be cGMP-ready in the first half of 2024. The company will also break ground on another industrial-scale facility in Europe in 2024. The company’s manufacturing technology supports both autologous and allogeneic-cell therapy processes and about 90% of cell -herapy modalities.
Source: Cellares
Formulation Development/Drug Product Manufacturing
Kindeva Launches Analytical Service Business
Kindeva Drug Delivery, a CDMO of drug-delivery services and autoinjectors, is launching a new global business unit offering integrated and stand-alone analytical support. In addition to increasing Kindeva’s analytical footprint, Kindeva’s recently opened 32,000-square-foot laboratories in Woodbury, Minnesota, will serve as the central hub for its expanded suite of analytical services. Kindeva will offer testing for extractables and leachables, elemental impurities, medical devices, and container-closure integrity.
Source: Kindeva Drug Delivery
Packaging
Stevanato Launches Small-Batch Lab Fill-Finish Service in US
Stevanato Group, a Piombino Dese, Italy-based provider of drug-containment, drug-delivery, and diagnostic products and services, has launched two new offerings for small-batch pharmaceutical manufacturing: the EZ-fill kit and a non-GMP laboratory fill–finish service at its Technology Excellence Centers in Boston and Piombino Dese, Italy.
This new service allows customers to assess and identify the possible effects of the fill–finish process on their product performance as early as the container-selection stage. Its new EZ-fill kit offers access to a customizable product for filling small batches with injectable formulations during clinical trials or commercial phases.
Source: Stevanato Group