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)
Drug Product cGMP Manufacturing

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

Get in Touch

    Kemwell Pharma