CHO Cell Line Platforms
Industry-standard CHO-S, CHO-K1 and CHO GS host systems engineered for metabolic stability, rapid growth and high expression titers (≥ 5 g/L).
Scalable mammalian cell culture solutions advancing mAbs and biopharmaceuticals from gene-to-clone development through commercial drug substance manufacturing.
At Shilpa Biologicals, we deliver end-to-end mammalian cell culture contract development and manufacturing organization (CDMO) services tailored for global pharmaceutical and biotechnology innovators. Operating out of our advanced biomanufacturing facility in Dharwad, Karnataka, India, Shilpa Biologicals provides flexible, cGMP-compliant solutions across all phases of biologics drug substance manufacturing.
Whether your molecule requires early-stage gene-to-cell line development, high-titer process optimization, or large-scale clinical and commercial production, our integrated team combines host cell expression technologies with single-use bioreactor systems to guarantee yield, consistency and regulatory speed.
Developing modern biopharmaceuticals demands robust expression systems paired with precise process parameters. Shilpa Biologicals maintains a backward-integrated architecture that spans from molecular engineering to commercial bulk drug substance manufacturing.
One campus, one quality system, one technology transfer to manage.
Developing modern biopharmaceuticals demands robust expression systems paired with precise process parameters.
Industry-standard CHO-S, CHO-K1 and CHO GS host systems engineered for metabolic stability, rapid growth and high expression titers (≥ 5 g/L).
Specialized expression utilizing HEK293 (human embryonic kidney) and SF9 (insect cell culture via baculovirus) for difficult-to-express proteins and viral vectors.
Tailored promoter selection, codon optimization, vector design and stable clone isolation to maximize specific productivity.
Rapid media and feed screening using Ambr® 15mL Micro Bioreactors and shake-flask screening arrays.
Bench-top 2L and 10L glass bioreactors used to establish design spaces through Quality by Design (QbD) and Design of Experiments (DoE) principles.
Robust execution across Fed-Batch, High-Density (HD) Fed-Batch and continuous Perfusion modes for sustained cell viability and high product yields.
Shilpa Biologicals offers tailored cGMP biomanufacturing solutions designed for USFDA and EMA compliance.
Engineered to maintain structural integrity, control glycosylation and eliminate product-related impurities at every step.
Vector design, CHO-K1/GS transfection, clone isolation, monoclonality confirmation and cGMP Master/Working Cell Bank (MCB/WCB) production.
PurposeEstablishing a genetically stable, high-titer seed train.
Expansion via shake flasks to 20/50 RM bioreactors, leading into 50L, 200L, 1000L or 2000L Single-Use Bioreactors (SUBs).
PurposeMaximizing cell density and product yield in fed-batch or perfusion mode.
Primary cell separation using depth filtration systems with 9.6 m² holder capacity per stream.
PurposeRemoving intact cells and cell debris while maintaining high product recovery.
Multi-column chromatography (up to 600 L/Hr capacity) and Tangential Flow Filtration (TFF, 0.5–5 m²).
PurposeCapturing target protein and purifying out host cell proteins (HCP) and DNA.
Low pH or detergent viral inactivation coupled with orthogonal nanofiltration in segregated pre/post-viral zones.
PurposeEnsuring bio-safety compliance with global regulatory guidelines (ICH Q5A).
Final Ultrafiltration/Diafiltration (UF/DF) formulation into bulk mammalian biologics stored in walk-in cold environments.
PurposeLong-term stability maintenance under controlled cold-chain conditions.
Optimized nutrient feeding strategies designed to extend cell longevity, prevent toxic metabolite accumulation (lactate and ammonia) and deliver reproducible glycosylation profiles.
Ideal for unstable recombinant proteins or high-density applications requiring constant media exchange and continuous product harvest, utilizing cell retention technologies.
Automated multi-step chromatography configurations including Protein A/G affinity, Anion/Cation Exchange (AEX/CEX) and Hydrophobic Interaction Chromatography (HIC).
Dedicated, physical airlock separation between pre-viral and post-viral purification streams to eliminate cross-contamination risks.
Process controls operating with 21 CFR Part 11 compliant automated data management platforms.
Shilpa Biologicals provides mammalian CDMO services engineered to accommodate complex protein architectures. Our mammalian manufacturing capabilities extend across the following therapeutic categories:
We offer cell line and upstream platform strategies for monoclonal antibodies (mAbs), biosimilar mAbs and bispecific constructs. Process optimization ensures correct heavy-and-light chain pairing while mitigating aggregate formation during downstream steps.
Complex molecules such as Fc-fusion proteins, recombinant blood factors and hyper-glycosylated proteins require careful culture environment control. Our single-use bioreactor systems maintain stable dissolved oxygen (DO), pH and temperature parameters to ensure proper glycan profiles and target biologic activity.
For advanced applications, including recombinant enzymes and antibody-drug conjugate (ADC) protein backbones, Shilpa Biologicals delivers precise manufacturing protocols backed by comprehensive characterization.
Our biomanufacturing facility in Dharwad, India, is built to support clinical development and commercial supply.
| Facility parameter | Stream 1 | Stream 2 |
|---|---|---|
| Footprint area | Stream 1Up to 2,000 Sqm dedicated DS area. | Stream 2Up to 2,000 Sqm dedicated DS area. |
| Bioreactor hardware | Stream 11000L, 200L, 50L Single-Use Bioreactors (SUBs). | Stream 22000L, 200L, 50L Single-Use Bioreactors (SUBs). |
| Seed train equipment | Stream 120L / 50L Rocking Motion (RM) bioreactors. | Stream 220L / 50L Rocking Motion (RM) bioreactors. |
| Clarification system | Stream 1Depth filtration holder capacity up to 9.6 m². | Stream 2Depth filtration holder capacity up to 9.6 m². |
| Downstream flow rates | Stream 1Chromatography systems at 1200 mL/min, 60 L/Hr, 600 L/Hr. | Stream 2Chromatography systems at 1200 mL/min, 60 L/Hr, 600 L/Hr. |
| Filtration capacity | Stream 1TFF holder capacity: 0.5 m² and 5 m². | Stream 2TFF holder capacity: 0.5 m² and 5 m². |
| Total facility DS capacity | Capacity8,000 Liters (2 × 2000L + 4 × 1000L active SUB infrastructure). | ExpansionDesigned for future expansion up to 16,000 Liters. |
We seamlessly transfer mammalian bulk drug substance directly into our automated fill-finish suites for Pre-Filled Syringes (PFS) and vial filling.
For multi-format vials and Pre-Filled Syringes (PFS).
Capable of storing over 1,000,000 vials and bulk drug substance containers securely.
Shilpa Biologicals operates state-of-the-art biomanufacturing facilities governed by an integrated Quality Management System (QMS). Our infrastructure operates under strict CDSCO regulations, holds WHO GMP certification and is engineered to maintain compliance with USFDA, EMA, ANVISA and PIC/S standards.
Analytical Method Development (AMD) and Quality Control (QC) platforms ensure that Critical Quality Attributes (CQAs) are systematically measured and controlled throughout production.
In-house testing capabilities include SEC-HPLC, CEX/AEX, LC-MS/MS glycan mapping, host cell residual DNA qPCR, and cell-based functional potency assays.
Regulatory affairs teams provide end-to-end support for IND (Investigational New Drug) and BLA (Biologics License Application) dossier compilation.
Shilpa Biologicals provides a fully backward-integrated mammalian CDMO platform spanning gene-to-clone development through commercial drug substance manufacturing. Operating 8,000L of single-use bioreactor capacity across dual independent 2,000 sqm streams, we deliver scalable fed-batch and continuous perfusion processes.
Headquartered in Dharwad, India, we serve biopharmaceutical partners globally, backing our operations with WHO GMP certification and strict USFDA/EMA compliance alignment to derisk international regulatory pathways while accelerating market timelines.
What partners ask before starting a mammalian cell culture program with us. Can’t find your answer?
Talk to our teamShilpa Biologicals provides CHO-S, CHO-K1, CHO GS, HEK293 and SF9 host cell platforms. We support both client-provided cell lines and custom clone development projects starting from vector design through Master Cell Bank (MCB) preparation.
Our facility features 20L/50L Rocking Motion (RM) seed bioreactors, alongside 50L, 200L, 1000L and 2000L Single-Use Bioreactors (SUBs). Total operational Drug Substance capacity stands at 8,000 Liters, with plans to expand to 16,000 Liters.
Yes. Shilpa Biologicals supports Fed-Batch, High-Density Fed-Batch and Continuous Perfusion operational modes tailored to product stability and harvest requirements.
Bio-safety is maintained through orthogonal viral clearance validation. This includes low-pH or detergent-based viral inactivation, nanofiltration and physical separation between pre-viral and post-viral purification zones within our 2,000 sqm DS streams.
Yes, Shilpa Biologicals is an integrated CDMO offering end-to-end services. We seamlessly transfer mammalian bulk drug substance directly into our automated fill-finish suites for Pre-Filled Syringes (PFS) and vial filling.
Accelerate your mammalian cell culture project with a flexible, high-capacity biomanufacturing partner in India. From gene-to-clone development to commercial drug substance release, our experts are ready to deliver.
Share the molecule, the host platform and the scale you are planning for. Our technical team will come back with what is possible on cell line development, drug substance manufacturing and fill-finish.
Shilpa Biologicals is a fully integrated mammalian cell culture CDMO in India, delivering end-to-end biologics drug substance manufacturing services to pharmaceutical and biotechnology companies across the globe. Operating from an advanced cGMP biomanufacturing facility in Dharwad, Karnataka, Shilpa Biologicals provides scalable mammalian manufacturing solutions spanning gene-to-cell line development, upstream and downstream bioprocessing, drug substance production and integrated drug product fill-finish. Our mammalian CDMO services support partners across the United States, European Union, Canada, Brazil, Japan and other regulated markets with the technical rigour and regulatory alignment that global submissions demand.
A mammalian cell culture CDMO is a contract development and manufacturing organization that specializes in developing and producing biopharmaceutical drug substances using mammalian expression systems such as CHO (Chinese Hamster Ovary), HEK293 and other host cell platforms. Mammalian cell culture manufacturing is critical for producing complex therapeutic proteins including monoclonal antibodies, bispecific antibodies, Fc-fusion proteins, biosimilars and recombinant proteins that require post-translational modifications such as glycosylation for clinical and commercial efficacy. Shilpa Biologicals operates as a mammalian CDMO in India, providing these specialized cell culture manufacturing capabilities to global innovators who require cGMP mammalian drug substance production backed by robust analytical characterization and regulatory filing support.
India has established itself as a strategic destination for mammalian biopharmaceuticals manufacturing. International pharmaceutical companies increasingly partner with Indian biologics CDMOs for mammalian cell culture for biopharmaceutical production for the following reasons:
Shilpa Biologicals is a subsidiary of Shilpa Medicare Limited, a publicly listed pharmaceutical company with over three decades of proven success in drug development, regulatory approvals and global supply across 50+ countries. This parentage provides Shilpa Biologicals with access to established quality management systems, deep regulatory expertise and robust operational infrastructure that underpin every mammalian CDMO engagement. As the dedicated biologics arm of the Shilpa group, Shilpa Biologicals brings this legacy of pharmaceutical excellence to the mammalian biopharmaceuticals space, combining heritage and innovation to serve global CDMO partners.
Shilpa Biologicals operates a purpose-built mammalian biomanufacturing facility in Dharwad, India, equipped with single-use bioreactor technology and independent drug substance manufacturing streams. Core capabilities for mammalian cell culture manufacturing include:
Shilpa Biologicals operates under an integrated Quality Management System (QMS) designed to meet the highest international regulatory standards for mammalian biologics manufacturing. Our biomanufacturing facility maintains the following certifications and compliance alignments:
In-house analytical capabilities including SEC-HPLC, LC-MS/MS glycan mapping, host cell residual DNA qPCR and cell-based potency assays support comprehensive drug substance characterization at every stage of the manufacturing process. Regulatory affairs teams at Shilpa Biologicals provide end-to-end support for IND and BLA dossier compilation, helping global partners navigate regulatory pathways across the US, EU, Brazil, Japan and other target markets.
For pharmaceutical and biotechnology companies seeking a reliable mammalian CDMO partner in India with global regulatory alignment, Shilpa Biologicals delivers the technical depth, facility scale and quality infrastructure required to advance biologics programs from early development through commercial supply. Whether the requirement is mammalian cell culture for biopharmaceutical production at clinical scale or full commercial biologics drug substance manufacturing, our integrated biomanufacturing platform in India is designed to accelerate your path to global markets. Contact Shilpa Biologicals to discuss your mammalian CDMO requirements.