Facility Update From Sever Pharma Solutions
In 2024, our Putnam site fully commissioned and qualified two new High Potent API processing suites, one for development and one for GMP manufacturing.
These flexible suites were designed with twin and single screw extrusion in mind, ideal for developing polymer-based drug products, including implants and co-extruded dosage forms that enable modified release and API protection. These suites handle everything from dispensing to extrusion to primary packaging, providing full-service, end-to-end manufacturing solutions in a high containment environment.
The development suite offers small-scale proof-of-concept equipment for prototyping polymer-based dosage forms with minimal API, and these techniques are conducive to working with a limited API. The development suite is also equipped with a twin screw extruder for processing of larger batches of developmental polymer-based drug products. Three single screw extruders are available in the suite to create co-extruded drug products to control your drug products’ release profile or to protect the API in the dosage form.
“Our ability to handle high potent APIs is supported by the appropriate containment devices for the entire extrusion process train. Our industrial hygiene data supports safe handling of OEB 5 compounds and hormonal APIs,” said Tony Listro, VP and Site Head.
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