Biologics Development

Kemwell provides integrated development services as a
one-stop solution for mammalian cell-culture based
protein therapeutics – monoclonal antibody, bi-specific or
multi-specific antibodies, fusion proteins, etc.

SERVICES

Kemwell provides integrated development and manufacturing services for companies that require one-stop solution for mammalian cell-culture based protein therapeutics

The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufacturing. Kemwell also undertakes standalone projects such as process optimisation, analytical method development or validation, formulation development and optimization, stability studies, resin reuse study, tech transfer and cGMP manufacturing, process characterization, etc.

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High Quality Biologics Development

Process Development

  • AMBR®250, Shake flasks, 5L, 10L (glass bioreactors), 50L (SUB), 80L (SS) – adaptable to support perfusion systems
  • Non-GLP and GLP tox material generation
  • Well characterized and geometrically similar bioreactors in pilot and GMP facility
  • Integrated with analytical development and formulation development services
  • Process characterization
Formulation Development

Analytical Development

Process Development
High Throughput Upstream and Downstream process development for all mammalian cell-culture based protein therapeutics.
  • Monoclonal antibodies
  • Fusion proteins
  • Bi-specific antibodies
  • Other mammalian cell-culture derived protein therapeutics
  • Novels and Biosimilars
WHY KEMWELL SERVICES

Asia’s best & India’s largest Biologics CDMO with integrated development and manufacturing capabilities

Kemwell is a biologics contract development and manufacturing (CDMO) company providing services to global pharmaceutical and biotech organizations. Our facilities; located in Bangalore; are designed and developed with technological support from a leading German pharmaceutical company.

  • Integrated Service Provider – Drug Substance and Drug Product
  • Diverse experience – monoclonal antibodies, complex fusion proteins, recombinant proteins and bispecific antibodies
  • First CDMO in India licensed to manufacture commercial DS
  • 4 years accomplishments – 7 projects in process development, 6 clinical manufacturing campaigns including Phase III batches for USA trial, commercial supplies for 1 DS and 3 DPs ongoing
  • Hybrid of technology – SS and SUB with scale flexibility to support early clinical to commercial demands – 400L, 1000L, 2000L
  • On time, In full and Right the first time
  • Time and cost competitive, customized service offerings
Fully Integrated
Services
State-of-the-art
Facilities
Flexible and Quick
turnarounds
Experience in
supplying

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