Kemwell is a leading biologics CDMO in Asia which provides services to global biopharmaceutical organizations. Kemwell, having established in 1980, has had long-term associations with pharma majors for small molecule CDMO. In 2016, Kemwell divested its small-molecule global business to Recipharm with an aim to focus on biologics CDMO business.
The facilities in Bangalore, India consists of a cGMP drug substance manufacturing suite with over 4000L bioreactor capacity in operation, a sterile fill and finish suite for cGMP drug product manufacturing and process development laboratories to support production of protein therapeutics using mammalian expression systems - mAbs, bi-specifics, fusion proteins, etc. Kemwell is capable of supporting novel, bio-better and biosimilar program's preclinical development, clinical development, cGMP clinical and commercial manufacturing.
?Process development capabilities: 5, 10 and 80 L scale. ?cGMP Drug substance: 80, 400 and 2x2000 L train. Expansion plan for additional 12 KL reactor capacity. ?cGMP Drug product: Liquid and lyophilized vials, sizes from 1 to 50 ml. PFS - future expansion. ?End-to-end mAb development and clinical manufacturing for USA clinical trial. ?Manufactured Phase III batches for US BLA filling. ?Commercial DP manufacturing - 20 batches per annum for one product ongoing. ?First commercial DS manufacturing to commence by Q1 2020. ?Invested into cGMP 'Cell Therapy' manufacturing facility which will be operational by Q3 2020.