A proven partner in accelerating biologics, from concept to commercial.
End-to-end CDMO services across the U.S. and India built on Speed, Scale and Stewardship.
A proven partner in accelerating biologics, from concept to commercial.
End-to-end CDMO services across the U.S. and India built on Speed, Scale and Stewardship.
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 across the U.S. and India. 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.
What We Offer
150+
Gene to GMP in 10 months
25+
20+ mAbs delivered to IND
250+
Regulatory expertise: FDA, EMA, PMDA
50 KL
Titers up to 12g/L using SynWeave™ + N-1 perfusion
2 KL &
4 KL
Up to 50KL GMP capacity
7-12 g/L
50L–4KL single-use bioreactors
>80%
500L microbial fermentors
Why Syngene Biologics
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
1M
Vials per day
Expertise Across the Spectrum
Our end-to-end services cover every stage of biopharmaceutical development and manufacturing—from cell line and process development to formulation, analytics, and validation. With a seamless, integrated approach, we bring your biologic products to life with speed, precision, and quality.
Regulatory Track Record
FDA, MHRA, and PMDA approvals for our manufacturing sites.
Successful Partnerships
25+ INDs enabled, fast-tracking clinical trial readiness.
Diverse Experience
140+ projects across multiple modalities delivered.
Efficiency & Quality
High titers, shorter timelines, no compromise on quality.
Syngene's Integrated Services Across the Drug Lifecycle
Our Offerings Across the Drug Lifecycle
Target ID, Validation and Lead Generation
Lead Optimization and Selection
Cell Line Development and Cell Banking (MCB/WCB)
Process Development, Analytical and Scale-up
GMP Supply (DS /DP) for Early-Phase Clinical Trials
Process Validation and Late-Stage Trials
Product Launch, and Commercial Manufacturing
Hit to Lead
Our Discovery Services provide drug candidates that have been screened and validated through our pre-clinical trials and humanized models
Gene to GMP
Our SynWeave™*
high-yielding cell line platform consistently provides 7-12 g/L titers using our process development capabilities in 10 months
Launch Ready
Our USFDA and EMA approved GMP facilities feature single-use bioreactors with capacities of 2,000 L and 4,000 L totaling 50,000 L designed to deliver economies of scale
Early Adopter
We are on the move with next generation technologies that reduce cost ($/g) by 50% using perfusion and continuous purification processing
mAbs | Bispecifics | ADCs | Biosimilars | Recombinant Proteins
One-Stop Shop for Biologics Development & Manufacturing
Capabilities Across Stages
Cell line / Strain development
Cell banking and characterization
Upstream process development
Downstream process development
Formulation development
Scale-up of DS and DP
Clinical and commercial manufacturing
Expertise:
Antibodies, ADCs, Bispecifics
Biosimilars, Recombinant proteins
Microbiome, Peptides, Growth Factors
pDNA, mRNA, More coming…
Infrastructure & Capacity:
End-to-end biologics capability across the US and India
700 L microbial GMP capacity with up to 500 L fermenter
1 million vials per day capability
50,000 L mammalian capacity with up to 4,000 L SUBs
Sequence to Vial in 10 months
Proprietary cell line development technology – SynWeave™
Our biologics offerings across the spectrum (DS and DP)
Mammalian
- 500 L 2,000 L and 4,000 L Single-use bioreactors
- Dedicated suites for multi-product handling
- Downstream Harvest (centrifuge or depth filtration)
- GLP-certified virus testing and clearance
USFDA, EMA, MHRA approved facilities
Microbial
- 200 & 500L Stainless Fermenters
- Continuous centrifugation
- 60 cm Chromatography
- Automated Tangential Flow Filtration (TFF)
Plasmid DNA & mRNA production system
DP Formulation
- Multi-product clinical line (vials / PFS¹)
- 1 million vials per day
- 12-50L Batch size
- Vial filling size (0.5ml – 10 ml)
- PFS filling size (0.3 – 1 ml)
Manual visual inspection, semi-auto labeling, manual packing