Kemwell Biopharma Pvt. Ltd.

Overview

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.

Standards & Methodologies

Kemwell Biopharma Pvt. Ltd. has not posted any Methodologies at this time.

Qualifications, Certifications, Accreditations & Licenses

Kemwell Biopharma Pvt. Ltd. has not posted any Certifications, Accreditations or Licenses at this time.