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Your Trusted Partner in Biologics Development & Manufacturing

Lupin Biotech CDMO is a fully integrated biologics development and manufacturing organization, offering end-to-end solutions for biopharmaceutical companies worldwide. Lupin’s strong legacy in innovation combined with its scientific expertise, regulatory excellence, established infrastructure and state-of-the-art facilities for both microbial and mammalian based drug substances and drug products enable Lupin to serve global markets efficiently and cost-effectively.

Who We Are

Lupin is one of the world’s leading pharmaceutical companies, serving over 100 countries with a legacy of innovation, quality, and global supplies. Lupin’s Biotech CDMO division is backed by decades of experience in developing, manufacturing, and commercializing biologics, which makes Lupin an ideal strategic partner for biotech and pharmaceutical innovators.

Key Highlights

Decades of experience in biologics development and commercialization

World-class R&D and manufacturing facilities approved by FDA, EMA, PMDA, TGA, and Health Canada

Service offering in monoclonal antibodies, mAb fragents, fusion protiens, antibody-drug conjugates and biosimiliars

High quality and scalable manufacturing at best-in-class service costs, leveraging India based operations

Our Differentiation: Beyond a Traditional CDMO

Unlike traditional CDMOs, Lupin Biotech’s CDMO is a commercial-stage biologics company with direct experience in bringing its own biologics to market. Our scientists, regulatory teams, and manufacturing experts have successfully guided biologic molecules from cloning to global approvals.

End-to-End Biologics Development
  • Clone & Cell Line Development

    Mammalian and microbial expression platforms, gene vector design, cloning, transfection and screening

  • Process Development & Scale-up

    From early-stage development at 10L to 2000L commercial-scale manufacturing

  • Drug Substance (DS) Manufacturing

    Capabilities spanning monoclonal antibodies, mAb-fragments, fusion proteins, pegylated proteins, antibody-drug
    conjugates and biosimilars

  • Drug Product (DP) Manufacturing

    Flexible capacity for vials, PFS, autoinjectors, and lyophilization

  • Regulatory Strategy & Filing Support

    BLA submissions , plus scientific advice briefing book preparations

  • Global Supply Chain & Distribution

    Ensuring seamless commercialization across markets