Bora Pharmaceuticals announced yesterday (27th) that its injectable manufacturing facility in Maryland, USA, has officially completed the installation and commissioning of the Groninger FlexPro 50 isolator production line for vials and prefilled syringes, and has now begun commercial-scale production.

The company stated that this milestone not only expands its capabilities in high-efficiency, sterile final-stage filling but also represents a significant step forward in Bora’s global sterile formulation manufacturing and CDMO operations.

Bora explained that Groninger, a German manufacturer, is globally recognized for its automated sterile pharmaceutical and cosmetic production equipment, renowned for high-precision and high-purity filling and packaging systems. The new production line employs the latest generation isolator technology, enabling sterile drug filling in an ultra-clean environment, effectively reducing contamination risks and enhancing process stability.

With this equipment upgrade, Bora can flexibly produce a wide range of injectable formulations, including pre-filled syringes (PFS) and vials, meeting the stringent quality, efficiency, and regulatory compliance requirements of global clients.

The production line is now fully operational for commercial manufacturing, serving multiple international partners. Among them is Accord BioPharma, the U.S. specialty drug subsidiary of Intas Pharmaceuticals, focusing on oncology, immunology, and critical care products. Bora is contract-manufacturing UDENYCA (pegfilgrastim-cbqv), a new prefilled injectable launched by Accord to support cancer patients by boosting immunity and reducing infection risk during treatment. Accord can also leverage Bora’s expertise in sterile manufacturing and regulatory management to ensure consistent quality and supply in global markets.

Bora emphasized that the Maryland facility expansion not only strengthens its North American production footprint but also underscores the company’s commitment to the high-end injectable market. Going forward, Bora plans to continue investing in smart manufacturing processes and high-standard quality systems to help global partners deliver innovative therapies safely and effectively to patients.

Resource: 保瑞報捷 美針劑廠量產