Kemwell Biopharma Pvt Ltd

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 is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations. Kemwell’s facilities, located in Bangalore, India, are designed with technological support from a leading German biopharma company.

Kemwell, was established in 1980 and has had long term associations with pharma majors such as Bayer, GlaxoSmithKline, Merck KGaA, Novartis, Pfizer and others for small molecule contract mfg. Our vision is to be a global leader and first-choice CDMO for biologics.

As a trusted biologics CDMO partner we provide end-to-end service from clinical development to commercial-scale manufacturing, we have an extensive process characterization infrastructure and experience in process development including complex mAbs - (Bispecific, Trispecific, ADC and Complex fusion proteins), Analytical Development (Bioassays, Mass Spec, and SPR), and formulation development (in-house stability studies, Liquid, Lyo, and high concentration protein formulation).

 In addition, we have expanded our DP fill finish services for Pre Filled Syringes (Optima) at our facility. We have consistently delivered high-quality, cost-effective solutions, supplying multiple DS and DP for US clinical trials on time.

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Certifications

• FDA (cGMP)

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Activity

• Abs (Antibodies), Peptide, protein, hormone & enzyme, BIOLOGICS manufacturing

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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)
• DEA: N/A
• BSL: 1, 2, 3, 4
• Therapeutic areas: N/A
• Markets: FDA (USA), EMA (EU), CDSCO (India)

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Batch Size / Reactor

• Small, Medium, Large, Fed-batch, 1 - 100 L, 100 - 1000 L, 1000 - 2000 L

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Services

• Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, Clean room rental, 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, 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

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