Outcome-Driven Biologics CDMO. From Gene to GMP in 10 Months.

Partner with a global CDMO with
FDA/EMA-compliant facilities.
Book a Meeting

Powering Progress from Molecule to Market

At Syngene, we empower biopharmaceutical companies to bring large molecule therapies to life through our state-of-the-art biologics CDMO services. With over 30 years of experience, we deliver integrated, expert-driven solutions that accelerate development, ensure compliance, and turn breakthrough ideas into market-ready products.

150+
Successful projects
25+

INDs enabled

250+

GMP batches

50 KL

Global GMP* capacity

2 KL & 4 KL
SUBs across the U.S. and India
7-12 g/L
Titer with SynWeave Platform
>80%
Green power

Why Syngene?

Gene to GMP in 10 Months
From cell line to GMP supply—fast, integrated, reliable.
Accelerate development with our SynWeaveâ„¢ platform and integrated capabilities that take your molecule from cell line to GMP supply in record time.
20+ Monoclonal Antibodies to IND
A proven record of advancing biologics to clinic.
Proven track record of advancing biologics programs, enabling over 20 successful IND filings across multiple therapeutic areas.
Global Regulatory Expertise
Trusted by FDA, EMA, and PMDA for compliant pathways.
Global Regulatory Expertise (FDA, EMA, PMDA) End-to-end support backed by deep regulatory experience across leading global health authorities—ensuring compliance at every stage.
High Titers up to 12 g/L
Efficiency delivered with SynWeaveâ„¢ and N-1 perfusion.
High Titers up to 12 g/L Achieve consistent, high-yield production with SynWeave™ and N-1 perfusion processes—delivering efficiency and cost advantages.
50 KL GMP Capacity
Dual-site scale across the U.S. and India.
50 KL GMP Capacity Across U.S. and India Access large-scale, flexible manufacturing with dual-site GMP facilities designed for seamless global supply.

Your One-Stop Biologics CDMO:
From Cell Line to Commercial Supply

Syngene’s integrated capabilities ensure speed,
compliance, and scalability across every stage of the biologics development lifecycle.

PhaseSyngene Capabilities
Cell Line DevelopmentSynWeaveâ„¢ CHO platform, single-cell cloning, stable pool generation, and in-depth
characterization
Process DevelopmentScalable upstream (USP) and downstream (DSP) processes with QbD and DoE-based
optimization
Analytical DevelopmentComprehensive method development, qualification, and detailed product
characterization
Viral Testing & ClearanceISO 9001:2015 & OECD GLP-certified BSL-2 labs for robust viral safety,
clearance, and testing
GMP ManufacturingDual-site drug substance (DS) and drug product (DP) manufacturing in the U.S. and
India, with 50L–50,000L bioreactor capacity
Regulatory SupportIND documentation, CMC guidance, and seamless global tech transfer expertise

Powering Progress from Molecule to Market

Syngene’s global biologics network is designed to give you speed, flexibility, and confidence in scaling your programs.

Our expanded facility in Bayview, Maryland, adds 50,000L of single-use bioreactor capacity, dedicated monoclonal antibody (mAb) and recombinant protein production lines, and advanced infrastructure built to meet global quality standards.

Together with our state-of-the-art sites in India, we deliver end-to-end biologics services from early development to commercial manufacturing, backed by world-class compliance and operational excellence.

Certifications

Explore Our Capabilities

Gain a complete overview of Syngene’s integrated biologics services. From cell line development to commercial-scale GMP manufacturing, our capabilities brochure outlines how we accelerate timelines, ensure compliance, and deliver scalable solutions worldwide.

Download Brochure

Get in touch

To view or email, Please share your details view

Download PDF
Download PDF

Your browser does not support this function.

To download, Please share your details

To view or email, Please share your details view

To download, Please share your details