+91-8026982400
[email protected]

Biologics cGMP Manufacturing

Facilities are FDA and EMA compliant. Licensed to manufacture
commercial DS and DP.

SERVICES

Kemwell provides integrated manufacturing services as a one-stop solution provider,
both drug substance and drug product.

Flexible to support quick turnarounds and increase speed to a clinic. Experience in supplying and supporting US IND trials, including Phase III manufacturing. 40+ customer audits, 3 QPs form EU, Mock PAI by ex-FDA auditor.

Biologics cGMP Manufacturing

High Quality Biologics cGMP Manufacturing

Drug Substance cGMP Manufacturing

Biologics cGMP Manufacturing

FACILITY

  • Multi-product, hybrid technology – SS & SUB, designed to purify high titer 5g/L @ 2000L, Best in class technology from Sartorius, Cytiva, Merck Millipore

CLINICAL MANUFACTURING

  • Clinical trial material supplied for trials in US and ROW up to 2000L scale

COMMERCIAL SUPPLY

  • Manufacturing one globally approved mAb at 2000L scale, 20+ batches per annum

BIOREACTORS

  • 80L 🡪 400L 🡪 2x2000L stainless steel bioreactors
  • 200L 🡪 1000L single use bioreactors

HARVEST

  • Harvest – Continuous centrifugation and/or lenticular filtration

PURIFICATION

  • Downstream – Multiple chromatography and TFF steps; pre- and post-viral segregation

CAPACITY EXPANSION

  • Provision to add up to 12000L bioreactor capacity (up to 6x2000L or 3x4000L)
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Drug Product cGMP Manufacturing

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Biologics cGMP Manufacturing
ASSURED QUALITY
Kemwell is an FDA and EMA compliant facility. Licensed to manufacture commercial DS and DP.
  • Flexible to support quick turnarounds and increase speed to clinic
  • Experience in supplying and supporting US IND trials, including Phase III manufacturing
  • Drug Substance- Up to 2000L scale
  • Drug Product– Lyophilized and Liquid Vials
  • 40+ customer audits, 3 QPs from EU, Mock PAI by ex-FDA auditor
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.

Biologics cGMP Manufacturing
  • 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 accomplishments since 2018 – 7 projects in process development, 6 clinical manufacturing campaigns including Phase III batches for US trial
  • Hybrid 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
About Us

Get in Touch

    [email protected]
    +91-8026982400
    Company
    Services
    Download Brochure
    Company
    Services
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