Kemwell Adds GMP Lyophilization CapabilityBy
Kemwell Biopharma, a global contract development and manufacturing services provider, has installed and qualified a commercial-scale lyophilizer. With this expansion, Kemwell has added GMP lyophilization capability to its sterile injectable offerings for biologics and pharmaceuticals. The lyophilizer has a shelf area of 7.5 sq.m. (~80 sq.ft) and is equipped with clean-in-place (CIP) and steam-in-place (SIP) facility. The maximum batch size ranges from 4000 (50-mL vial) to 29,000 (2-mL vial). With this service offering, Kemwell offers a range of services from lyo-cycle development, small-scale manufacturing for preclinical studies and GMP manufacturing of lyophilized vials for clinical and commercial products.
Source; Kemwell Biopharma