Kemwell Biopharma has expanded its lyophilization capacity with the installation and qualification of a commercial scale lyophilizer, adding GMP lyophilization capability to its sterile injectable offerings for biologics and pharmaceuticals. The lyophilizer has a shelf area of 80 sq.- ft. and is equipped with CIP and SIP facility. The maximum batch size ranges from 4,000 (50ml vial) to 29,000 (2ml vial). With the expansion, the company offers the complete range from lyo-cycle development, small-scale manufacturing for preclinical studies and GMP manufacturing of lyophilized vials for clinical and commercial products.
According to Anurag Bagaria, chairman and managing director, “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.