Kemwell Biopharma has announced it has installed and qualified its 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 7.5m² and is equipped with CIP and SIP facility. The maximum batch size ranges from 4,000 (50ml vial) to 29,000 (2ml vial). With this service offering, Kemwell now offers the complete range from lyo-cycle development, small-scale manufacturing for pre-clinical studies and GMP manufacturing of lyophilized vials for clinical and commercial products.
Anurag Bagaria, chairman and managing director, said: "The outsourcing of services in bio/pharmaceutical industry is growing and Kemwell will continue to invest into technologies to support our customers’ needs."
In 2008, Kemwell entered into a strategic collaboration with Boehringer Ingelheim, Germany. These facilities have been designed with the engineering and operational support of Boehringer Ingelheim. Kemwell’s biotechnology capabilities now include process development and manufacturing of drug substances and drug products for pre-clinical studies in 80L scale bioreactors, as well as for cGMP clinical and commercial manufacturing in 400L and 2,000L bioreactors with corresponding downstream processing, fill and finish in liquid and lyophilized vials.
The quality systems in the biopharmaceutical facilities are established using Kemwell’s 30+ years of pharmaceutical manufacturing experience that have been certified by EMA, FDA and PMDA.