Kemwell Biopharma | Kemwell Biopharma Pvt Ltd
SpainQUÍMICO-SINTÉTICOBIOLÓGICOSSERVICIOSFDF / PRODUCTOS FARMACÉUTICOSFarmacéutico
Kemwell is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations
Sobre la Planta
Kemwell Biopharma is a leading mammalian cell-based biologics Contract Development and Manufacturing Organization (CDMO) headquartered in Bengaluru, India. As a trusted partner to global biopharmaceutical companies, Kemwell provides end-to-end biologics development and manufacturing services — from cell line and process development to cGMP clinical and commercial manufacturing.
Kemwell’s 15,000 sq. m state-of-the-art facility, designed and developed in collaboration with Boehringer Ingelheim, offers world-class infrastructure and capabilities, including:
- Process Development & Characterization: Expertise in developing processes for complex biologics such as monoclonal antibodies (mAbs), bispecific and trispecific antibodies, fusion proteins
- Analytical Development: Development, qualification and validation of in-process and release tests for biologics.
- Formulation Development: Development of liquid and lyophilized formulations, and high-concentration protein formulations. Performing stability studies to confirm the final formulation.
- Manufacturing Capabilities: Over 5,000 L mammalian cell culture capacity (both stainless steel and single use bioreactors) for cGMP drug-substance manufacturing, along with sterile fill-finish facilities for both vials and prefilled syringes (PFS) for drug-product manufacturing.
In 2025, Kemwell successfully completed a U.S. FDA Pre-Approval Inspection (PAI) for an injectable drug product for the U.S. market — demonstrating compliance with global regulatory standards and reinforcing Kemwell’s commitment to quality and manufacturing excellence.
Established in 1980, Kemwell has a long-standing legacy of partnerships with global pharmaceutical majors such as Bayer, GSK, Merck KGaA, Novartis, and Pfizer. After divesting its small-molecule business in 2016, Kemwell now focuses exclusively on mammalian cell-based biologics, leveraging deep technical expertise and operational excellence to deliver cost-effective, high-quality solutions from preclinical development through commercial manufacturing.
Atributos y Capacidades
CATEGORÍA / PRODUCTO
- QUÍMICO-SINTÉTICO
- FDF / PRODUCTOS FARMACÉUTICOS
- SERVICIOS
TAMAÑO DEL LOTE
- Pequeño
- Medio
- Grande
FASE
- Comercial (Fase IV)