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Biologics CDMO Services for Early Phase Innovators across the US and India – Speed, Scale, and Scientific Strength
Accelerate your journey from Sequence to Vial with Syngene’s one-stop biologics CDMO platform – engineered for early-stage biopharma.
Why Choose Syngene as Your Biologics CDMO Partner?
Syngene is a global CRDMO offering end-to-end Biologics services for mammalian and microbial systems across modalities and therapeutic areas. We also offer Sterile Fill-Finish and Viral Testing services, making us a one-stop solution for all Biologics requirements – Target to Therapy!
At Syngene, we are committed to incrementally adding new layers of expertise to drive continued innovation. Solving our partners complex research and manufacturing problems, has been the hallmark of our success, and sustainable long-term relationships.
Speed to Clinic
- 9 weeks from DNA to Research Cell Bank
- Sequence to Vial in 10 months
High Titers, Scalable Yields
- Industry-leading titers of 6-12 g/L using SynWeave™ platform
- Scalable from 2L bench scale to 4000L GMP manufacturing
Deep Expertise, Tailored to You
- Manufacturing facilities approved across the US and India by US FDA, EMA, ANVISA and PMDA
- Proven experience with complex molecules: bispecifics, Fc fusions, and antibody fragments
Globally Integrated Capabilities
- Seamless tech transfer and project continuity across US and India with total SUB capacity of 50000 liters
- In-house bioanalytics, bioassays, viral testing and stability programs for full IND readiness
Your One-Stop Shop CDMO
Phase
Syngene Capabilities
Cell Line Development
SynWeave™ CHO platform, single-cell cloning,
characterization
Process Development
Scalable USP/DSP processes, QbD, DoE-based optimization
Analytical Development
Method development, qualification, characterization
Viral Testing and Clearance
ISO 9001:2015 & OECD GLP certified, state-of-the-art
BSL-2 laboratory
GMP Manufacturing
Drug substance and drug product, dual sites in the US
and India
Regulatory Support
IND documentation, CMC support, tech transfer
Ready to accelerate your mAb development?
Get the full overview of Syngene’s end-to-end CDMO services
Case Studies
Small Molecule Development and Manufacturing
Syngene offers chemical development, formulation, analytical, clinical development, and manufacturing services across small molecules, oligonucleotides, HPAPIs, and performance and specialty materials.
Clinical Development services
Syngene supports early-phase to late-phase clinical trials required for drug development programs across a wide range of therapeutic areas.
Biologics Development and Manufacturing
Syngene offers biologics development and manufacturing solutions for both mammalian and microbial systems. We also offer services from our sterile Fill-Finish facility and Viral Testing facility.
Discovery
Syngene offers integrated and standalone services across the drug discovery continuum, from Target Identification to IND enabling services.