Kemwell Biopharma Pvt Ltd
Kemwell is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations
About the plant
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.
Certifications
- ISO
- FDA (cGMP)
- World Health Organization (GMP / HACCP)
Activity
- Abs (Antibodies), Peptide, protein, hormone & enzyme, BIOLOGICS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
- Controlled substance: N/A
- BSL: 1, 2, 3, 4
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan), CDSCO (India), MHRA (UK)
Batch Size / Reactor
- Small, Medium, Large, Batch, Fed-batch, Perfusion, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L, 2000 - 5000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Lyophilization cycle development, Stability studies design, Stability studies execution, ICH Stability studies, Comparability studies, Downstream, Fill&Finish, Cell line development, Cell banking, Sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Lyophilization, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Clean room rental, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission
Address
Kemwell Biopharma Pvt. Ltd. 34th KM, Tumkur Road T-Begur, Nelamangala
Year
1980
India
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