Outcome-Driven Biologics CDMO. From Gene to GMP in 9 Months.
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.
INDs enabled
GMP batches
Global GMP* capacity
Why Syngene?
Gene to GMP in 9 Months
Accelerate development with our SynWeave™ platform and integrated capabilities that take your molecule from cell line to GMP supply in record time.
20+ Monoclonal Antibodies to IND
Proven track record of advancing biologics programs, enabling over 20 successful IND filings across multiple therapeutic areas
Global Regulatory Expertise
High Titers up to 12 g/L
50 KL GMP Capacity
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.
| Phase | Syngene Capabilities |
|---|---|
| Cell Line Development | SynWeave™ CHO platform, single-cell cloning, stable pool generation, and in-depth characterization |
| Process Development | Scalable upstream (USP) and downstream (DSP) processes with QbD and DoE-based optimization |
| Analytical Development | Comprehensive method development, qualification, and detailed product characterization |
| Viral Testing & Clearance | ISO 9001:2015 & OECD GLP-certified BSL-2 labs for robust viral safety, clearance, and testing |
| GMP Manufacturing | Dual-site drug substance (DS) and drug product (DP) manufacturing in the U.S. and India, with 50L–50,000L bioreactor capacity |
| Regulatory Support | IND 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.