India 
USA
UK
South Africa
Australia
Philippines
Germany
Netherlands
Mexico
Brazil
Canada
Switzerland
Lupin Biotech’s CDMO offers expert biologic development capabilities, combining cutting-edge science, regulatory expertise, and state-of-the-art infrastructure to support our partners at every stage of the development lifecycle. Lupin ensures efficient and scalable solutions for Drug Substance (DS) and Drug Product (DP) development through our deep understanding of complex biologics and the experience of our development team.
Lupin’s Chemistry, Manufacturing, and Controls (CMC) expertise can ensure a seamless transition from early-stage development through to commercial manufacturing. Lupin provides:
End-to-end CMC development support, including regulatory documentation for INDs, BLAs, and marketing authorizations
Customised process development strategies for monoclonal antibodies (mAbs), fusion proteins, recombinant peptides/proteins, and antibody-drug conjugates (ADCs)
Analytical method development and validation for product characterization, comparability studies, and regulatory compliance
Comprehensive technology transfer capabilities, ensuring smooth scale-up from laboratory to commercial production
We provide high-yield, stable cell line development using mammalian and microbial expression systems, ensuring optimal productivity and quality, no matter your platform. Lupin has expertise in:
Microbial and Mammalian Expression Systems
Gene and Vector Design
Cloning and Transfection
Clone and Single-cell Screening
R&D and Master Cell Bank Maintenance and Characterization
Lupin’s upstream development expertise ensures efficient cell culture and fermentation strategies, optimizing yield, scalability, and product quality. Our services include:
Upstream Process Development
Media Design and Optimization
Process Characterization
Continuous Process Improvement
Mammalian Cell Culture Scale-Up Study: 15 mL to 50 L Scale
Microbial Fermentation Scale-Up Study: 20 mL to 50 L Scale
Lupin employs cutting-edge recovery and purification technologies to ensure high product purity and yield. Lupin provides:
Downstream Purification Process Development and Optimization
Re-folding Process Development and Optimization
Column Design and Optimization
Process Characterization
Process Improvement
Process Validation
Lupin’s formulation and drug product development capabilities ensure a scalable process, a stable product, and regulatory compliance for your biologic.
Formulation Process Development
Final Filtration & Fill-Finish Optimization
Excipient Range Studies
Process Characterisation
Process Improvement
Process Validation
Lupin offers a comprehensive suite of analytical development services to ensure your biologic meets global regulatory standards. We incorporate robust characterization methods, along with comparability assessment, and quality control strategies to ensure a complete
understanding of your product’s quality. Our advanced analytical capabilities include:
Analytical Method Development (HPLC, Spectrophotometric, Electrophoretic Modalities)
Functional Assay Development (ELISA And Cell-based Assays)
Method Qualification and Validation
Analytical support for process development, product as well as process characterization and comparability studies
We focus on data-driven process optimization to ensure high yield, consistency, and regulatory compliance with a focus on:
Binding Assay Development (Octet, SPR)
LCMS, MS/MS-Based Characterization
Method Qualification and Validation
Lupin Biotech’s CDMO is powered by a seasoned team of over 140 R&D professionals, including PhDs, postgraduates, and industry experts with extensive experience in biologics development:
Regulatory Expertise
Expert knowledge of global regulatory frameworks and requirements, ensuring smooth IND/BLA and other submissions.
Successful Track Record
Lupin has secured approvals from regulatory authorities around the globe.
- Marketing authorizations in the EU & Japan (Etanercept), India (Etanercept, Filgrastim, Pegfilgrastim & Ranibizumab), Canada (Etanercept and Pegfilgrastim) and a BLA filing for Pegfilgrastim in the U.S.
- Clinical trial applications across multiple (10) EU countries and 2 FDA IND approvals
- Regulatory submissions in Australia & Canada (Etanercept, approval in progress)
Scientific Excellence
Decades of experience in cell line engineering, process development, and large-scale biologics manufacturing.
Extensive experience interacting with FDA, EMA, HC, TGA, PMDA and other agencies
- FDA (U.S.): 7 BPD Type 2 consultations,
1 BLA , EMA (Europe): 7 Scientific Advice (SA) meetings 2 MAAs - PMDA (Japan): 4 consultation meetings
- Health Canada (Canada): 2 consultation meetings 3 MAAs
- TGA (Australia): 1 consultation meeting,
1 MAA
Lupin Biotech’s CDMO is powered by a seasoned team of over 140 R&D professionals, including PhDs, postgraduates, and industry experts with extensive experience in biologics development.
Expert knowledge of global regulatory frameworks and requirements, ensuring smooth IND/BLA and other submissions.
Lupin has secured approvals from regulatory authorities around the globe.
- Marketing authorizations in the EU & Japan (Etanercept), India (Etanercept, Filgrastim, Pegfilgrastim & Ranibizumab), Canada (Etanercept and Pegfilgrastim) and a BLA filing for Pegfilgrastim in the U.S.
- Clinical trial applications across multiple (10) EU countries and 2 FDA IND approvals
- Regulatory submissions in Australia & Canada (Etanercept, approval in progress)
Decades of experience in cell line engineering, process development, and large-scale biologics manufacturing.
Strong partnerships with biotech and pharmaceutical companies across the U.S., Europe, Japan, and emerging markets.
- FDA (U.S.): 7 BPD Type 2 consultations, 1 BLA
- EMA (Europe): 7 Scientific Advice) meetings, 2 MAAs
- PMDA (Japan): 4 consultation meetings, 2 MAAs
- Health Canada (Canada): 2 consultation meetings 3 MAAs
- TGA (Australia): 1 consultation meeting, 1 MAA
Lupin Biotech’s CDMO is your preferred strategic partner for biotherapeutic development. Whether you require process development, early-stage clinical manufacture or large-scale commercial production, Lupin has the expertise to bring your biologic to market successfully.