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: AMBR250, 5L, 10L and 80L scale bioreactors.
- – cGMP Drug substance: 80, 400 and 2×2000 L train. Expansion plan for additional 12 KL reactor capacity in an existing shell place of 26,000 sq. ft.
- – cGMP Drug product: Liquid and lyophilized vials, sizes from 2 – 50 ml.
- – Successfully manufactured Phase III clinical campaign for US trials also several clinical campaigns for EU and APAC trials.
- – Commercial manufacturing – One globally approved DS for APAC region with annual commitment of 30 batches at 2000 L scale. Two DPs for APAC market, one each liquid and lyophilised vial. Around 60 batches per annum commitment.
- – cGMP ‘Cell Therapy’ manufacturing facility to be operational by Q2 2021.
For more information, visit http://www.kemwellbiopharma.com/