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
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Clone & Cell Line Development
Mammalian and microbial expression platforms, gene vector design, cloning, transfection and screening
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Process Development & Scale-up
From early-stage development at 10L to 2000L commercial-scale manufacturing
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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
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Regulatory Strategy & Filing Support
BLA submissions , plus scientific advice briefing book preparations
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Global Supply Chain & Distribution
Ensuring seamless commercialization across markets