A fully integrated biologics CDMO advancing therapeutic proteins from gene to commercial supply, within a single organization.
Shilpa Biologicals is a fully integrated biologics CDMO built to advance therapeutic proteins from gene to commercial supply within a single organization.
We support global pharma companies, biotech innovators and investors developing monoclonal antibodies, recombinant proteins and antibody-drug conjugates. Our model combines mammalian and microbial drug substance manufacturing, analytical characterization, drug product and fill-finish under one quality system.
Sponsors gain global regulatory standards, technical depth and the operational agility of a partner focused only on biologics. The result is shorter handoffs, controlled cost and a clear development path across clinical and commercial phases.
A WHO-GMP biologics manufacturer operating to ICH and PIC/S GMP quality systems, with an EU GMP-approved fill-finish line, built to the expectations of regulators across the US, EU, Canada, Brazil and Japan.
Two drug-substance platforms and full drug-product capability, delivered under one quality system from clinical batches to commercial supply.
CHO-based production for monoclonal antibodies and recombinant proteins.
ExplorePichia and E. coli fermentation for recombinant proteins and albumin.
ExploreMethod development, release testing and comparability aligned to ICH.
ExploreFormulation and aseptic fill-finish on an EU GMP approved line.
ExploreShilpa Biologicals partners with pharma and biotech teams developing biologic therapeutics for global markets. Share your molecule, target indication and development stage. Our technical team will outline a development and manufacturing path.
One organization, connected teams, no vendor handoffs.
A partner focused only on biologics: integrated capability, dual drug-substance platforms and global-market quality.
Partner with usOne partner from cell line to fill-finish, with development, manufacturing and testing under a single organization, so process knowledge stays intact from clinical batches to commercial supply.
WHO-GMP and ICH systems, PIC/S GMP and CDSCO compliance, and an EU GMP approved fill-finish line, with data built for filing across the US, EU, Canada, Brazil and Japan.
Global quality standards delivered with the cost efficiency of an integrated single-site operation, so affordability comes from efficient processes rather than any compromise on compliance.
Adaptive capacity and responsive timelines that scale in step with the needs of your program, with dedicated project management as a single point of accountability.
A single focus on biologics keeps our teams, facilities and quality systems aligned to large-molecule development and manufacturing, with no competing priorities for capacity.
Quality at Shilpa Biologicals is built into every process, not inspected in at the end. Manufacturing operates under WHO-GMP and ICH guidelines, supported by PIC/S GMP and CDSCO compliance. The aseptic fill-finish line holds EU GMP approval for sterile drug product destined for European markets.
Our quality systems cover method validation, batch release, environmental monitoring and stability programs aligned to ICH conditions. Documentation practices follow data integrity principles that support regulatory inspections and partner audits. Sponsors receive the technical records, comparability data and regulatory support needed for submissions across the United States, European Union, Canada, Brazil and Japan.
This quality foundation lets global partners outsource biologics development with confidence, knowing each batch meets the standards required for clinical use and commercial distribution.
Serving partners across the Americas, Europe and the Asia-Pacific, with dossiers and batch release supported market by market.
United States
Canada
Austria
Belgium
France
Germany
Italy
Netherlands
Poland
Portugal
Spain
Sweden
Switzerland
United Kingdom
Australia
Japan
South Korea
Brazil
Russia
IndiaCampus
Indonesia
Malaysia
Philippines
Thailand
Egypt
Israel
Kenya
Nigeria
Saudi Arabia
South Africa
Türkiye
United Arab Emirates
Argentina
Chile
Colombia
MexicoEverything sponsors ask about developing and manufacturing biologics with Shilpa. Can't find your answer?
Talk to our teamA fully integrated biologics CDMO manages every stage of biologic development and manufacturing within one organization. Shilpa Biologicals connects cell line and process development, mammalian and microbial drug substance production, analytical testing, drug product and fill-finish, removing vendor handoffs and protecting process knowledge from early development through commercial supply.
Two expression platforms support drug substance manufacturing at Shilpa Biologicals. Mammalian cell culture based on CHO produces monoclonal antibodies and recombinant proteins. Microbial fermentation using Pichia and E. coli produces recombinant proteins including human albumin. Both platforms scale from clinical batches to commercial volumes under a single quality system.
Global GMP standards govern manufacturing at Shilpa Biologicals. The site operates under WHO-GMP and ICH guidelines, with PIC/S GMP and CDSCO compliance. The aseptic fill-finish line holds EU GMP approval for sterile drug product. This framework supports regulatory submissions across the United States, European Union, Canada, Brazil and Japan.
End-to-end process ownership supports clinical and commercial supply at Shilpa Biologicals. The same development teams design, transfer and scale each process, which keeps technical knowledge intact. Sponsors move from early clinical batches to commercial production without changing partners, reducing comparability risk and protecting timelines across the biologic lifecycle.
Shilpa Biologicals is a fully integrated biologics CDMO that develops and manufactures complex biologic therapeutics for partners worldwide. The company operates as a single-source biologics contract development and manufacturing organization, taking molecules from early development through to commercial supply within one connected operation. This model gives sponsors a CDMO for biologics that combines scientific depth, global standards and operational agility under one quality system. Working with one organization across the program reduces the coordination, contract and timeline overhead that comes with managing multiple specialist vendors.
Shilpa Biologicals supports:
Programs span therapy areas such as oncology and immunology, where monoclonal antibodies, recombinant proteins and antibody-drug conjugates are central to modern biologic treatment.
The integrated CDMO model connects every stage of the biologic lifecycle, so process knowledge stays intact and vendor handoffs are removed. The same teams design, transfer and scale each process, which reduces comparability risk and shortens the path from development to dependable commercial supply.
The end-to-end model spans:
Dedicated project management coordinates technology transfer across these stages and gives sponsors a single point of accountability for the program.
Drug substance manufacturing runs across two expression platforms that together cover a broad range of biologic molecules:
This dual-platform capability lets Shilpa Biologicals support monoclonal antibodies, recombinant proteins, antibody-drug conjugates and biosimilar molecules. Each program is matched to the host system and process that suit its molecular profile and intended scale. Process design, scale-up and characterization stay connected across both platforms, which supports a consistent quality profile as a program grows. Biosimilars will be available commercially after relevant patent expiry.
Beyond drug substance, the CDMO completes the route to a finished biologic with formulation, sterile drug product and full analytical support:
These services support process changes, technology transfer and regulatory submissions throughout a program, which keeps a molecule moving without changing partners. Comparability and stability data generated through these services support both clinical progression and post-approval changes.
Quality and regulatory compliance sit at the center of the operation. Documentation follows data integrity principles that support regulatory inspections and partner audits, which prepares each program for submission in priority markets.
Certifications and standards include:
Priority markets supported include the United States, European Union, Canada, Brazil and Japan. For partners evaluating biologics CDMO companies on quality and trust, these credentials provide the assurance needed to outsource high-value biologic programs with confidence.
As a biologics CDMO company in India, Shilpa Biologicals combines global quality standards with the cost efficiency and operational agility of an integrated single-site operation. Biopharmaceutical contract manufacturing in India gives sponsors access to skilled scientific teams and qualified infrastructure at a structure that supports affordability without compromising regulatory rigor. The company focuses exclusively on biologics, which keeps its teams, facilities and quality systems aligned to large-molecule development and manufacturing. From novel monoclonal antibodies and recombinant proteins to antibody-drug conjugates and recombinant human albumin, Shilpa Biologicals supports partners advancing biologic therapeutics from early development to commercial market. Engagement models range from standalone process development, drug substance or fill-finish services to full programs that run from cell line through commercial release. Organizations comparing biologics CDMO partners for development, drug substance, drug product or commercial supply can engage Shilpa Biologicals as a fully integrated, affordable and globally compliant biologics CDMO.