Description
Kemwell Biopharma is a contract biologics development and contract manufacturing organization (CMO) that provides a wide array of services to global biopharmaceutical firms. With state-of-the-art facilities located in Bangalore, India, Kemwell is outfitted with advanced technologies developed in collaboration with a leading German pharmaceutical company. The company offers cost-effective access to high-quality development and manufacturing services primarily focused on mammalian cell culture-based products. Kemwell operates a spacious 15,000 sq. m. facility that includes a cGMP drug substance manufacturing area featuring over 4500L bioreactor capacity, as well as sterile fill and finish areas.
Services include:
- 505(b)(2)
- Accelerated Stability Studies
- Aerosol
- Analytical Services
- Animal Health
- Aseptic Fill/Finish
- Assay Development
- Biological Testing
- Biologics
- Process Development
- Bioprocess Validation
- Bioprocessing
- Disposable/Single-Use
- Biosimilars
- Blending
- Cell Culture Media Development
- Chiral Separations
- R&D
- Chromatography
- Clean in Place / Sterilization in Place (CIP/SIP)
- Clinical Analysis
- Clinical Supply Management
- Clinical Trials
- Chemistry (CMC)
- Manufacturing
- Coating & Lamination
- Comparator Drug Blinding
- Comparator Drug Purchasing
- Contract Development and Manufacturing (CDMO)
- Contract Manufacturing (CMO)
- Contract Packaging
- Contract Research (CRO)
- Dosage Form Development
- Downstream Processing
- Drug Development
- Encapsulation
- Fermentation
- Filling
- Capsule
- Syringe
- Vials
- Fluid Bed Processing
- Forced Degradation Studies
- Formulation Development
- Controlled Release
- Granulation
- In Vitro Testing
- IND/NDA Submissions
- Lot Release Testing
- Lyophilization
- Mammalian Cell Culture
- Aseptic Fill-Finish
- Bioequivalence
- Clinical Trial Materials
- Controlled Substances
- Creams & Ointments
- Dose Form
- Non-Sterile
- Sterile
- Ethical
- Gels
- Generics
- Injectables
- Liquids
- Oral Drug Delivery
- Orally Dispersible Tablet
- OTC
- Parenterals
- Small Volume
- Peptides
- Powders
- Proteins
- Semisolids
- Solid Dosage
- Solutions & Suspensions
- Suppositories
- Sustained Release
- Pre-filled
- Tablets
- Topicals
- Mass Spectrometry
- Micro FT-IR Analysis
- Microbiological Testing
- Mixing & Blending
- Mixing and Granulating Equipment
- Packaging
- Blister
- Cold Form
- Parenterals Development
- Particle Characterization
- Particle Size Analysis
- Photostability
- Pilot-Scale Filling
- Polymerase Chain Reaction
- Preformulation
- Process Characterization
- Process R&D
- Process Validation Studies
- Project Management
- Protein Extraction/Purification
- Protein Synthesis
- Purification
- Quality QA/QC
- R&D Services
- Raw Materials Analysis
- Scale-Up
- Serialization
- Spray Drying
- Stability Studies
- Stability
- ICH
- Sterile Filling
- Sterility Testing
- Sterilization
- Storage
- Tablet Coating
- Technology Transfer
- Transdermals/Transmucosals
- UV-VIS Spectrophotometer Analysis
- Validation
- Cleaning Equipment
- Filtration
- Contract Research
- Protein and Peptide
- Clinical Dose
- Clinical Packaging
Kemwell Biopharma is dedicated to advancing biotechnology solutions and ensuring quality across all stages of drug development and manufacturing. For more information, please visit kemwellbiopharma.com.
Capabilities
- Accelerated Stability Studies
- Aerosol
- Analytical Services
- Animal Health
- Asceptic Fill-Finish
- Assay Development
- Bioequivalence
- Biological Testing
- Biologics
- Bioprocess Validation
- Bioprocessing
- Biosimilars
- Blending
- Blister
- Capsule
- Cell Culture Media Development
- Chemistry (CMC)
- Chiral Separations
- Chromatography
- Clean in Place / Sterilization in Place (CIP/SIP)
- Cleaning Equipment
- Clinical Analysis
- Clinical Dose
- Clinical Packaging
- Clinical Trial Materials
- Clinical Trials
- Coating & Lamination
- Cold Form
- Comparator Drugs
- Contract Development and Manufacturing (CDMO)
- Contract Packaging
- Contract Research (CRO)
- Controlled Release
- Controlled Substances
- Creams & Ointments
- Disposable/Single-Use
- Dosage Form Development
- Dose Form
- Downstream Processing
- Drug Development
- Encapsulation
- Ethical
- Fermentation
- Filling
- Filtration
- Fluid Bed Processing
- Forced Degradation Studies
- Formulation Development
- Gels
- Generics
- Granulation
- ICH
- In Vitro Testing
- IND/NDA Submissions
- Injectables
- Liquids
- Lot Release Testing
- Lyophilization
- Mammalian Cell Culture
- Mass Spectrometry
- Micro FT-IR Analysis
- Microbiological Testing
- Mixing & Blending
- Mixing and Granulating Equipment
- Non Sterile Dosage
- Oral Drug Delivery
- OTC
- Packaging
- Parenterals
- Parenterals Development
- Particle Size Analysis
- Peptides
- Photostability
- Pilot-Scale Filling
- Polymerase Chain Reaction
- Powders
- Preformulation
- Process Characterization
- Process Development
- Process Validation Studies
- Project Management
- Protein and Peptide
- Protein Extraction/Purification
- Protein Synthesis
- Proteins
- Purification
- Quality QA/QC
- Raw Materials Analysis
- Research & Development
- Scale-Up
- Semisolids
- Serialization
- Solid Dosage
- Solutions & Suspensions
- Spray Drying
- Stability Studies
- Sterile
- Sterile Filling
- Sterility Testing
- Sterilization
- Storage
- Suppositories
- Sustained Release
- Syringe
- Tablet Coating
- Tablets
- Technology Transfer
- Topicals
- Transdermals/Transmucosals
- UV-VIS Spectrophotometer Analysis
- Validation
- Vials
Contact Information
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