From Cell Line to Clinic
4 Months Sooner with mAb Accelerator
The mAb Accelerator is designed to accelerate biopharma success by:
Early Investment: We commit resources upfront, helping our customers overcome early financial and operational barriers.
Risk Sharing: Syngene absorbs early technical and operational risk so our customers can advance their programs before certainty sets in.
Flexible Commercial Models: Stage‑based, biotech‑aligned payment structures minimize upfront spend and let you advance without straining capital.
Talk to our Technical Experts
The mAb Accelerator Program is created in response to a fundamental disconnect we repeatedly saw in early and mid‑stage biologics development i.e. innovation is moving faster than the systems supporting it. Across biotech and biopharma, we observed strong science being delayed, not because of technical limitations but because of organizational uncertainty, funding cycles, governance approvals, partner alignment, and portfolio decisions. These delays often occur before the most value‑creating work cell line development could even begin.
To address these challenges, Syngene introduces the mAb Accelerator Program, which initiates Cell Line Development immediately, so your molecule progresses while you secure approvals and funding. The program then advances your asset from Gene‑to‑GMP in as little as 9 months through an integrated end‑to‑end CDMO footprint across the U.S. and India. It is powered by SynWeave™ high‑titer CLD platform (7–12 g/L), FDA/EMA‑approved sites, and state‑of‑the‑art 2 KL and 4 KL single‑use bioreactors, totaling 50 KL of global single‑use capacity.
3 Core Problems mAb Accelerator Solves for Customers
mAb Accelerator Program is designed to help biopharma companies accelerate innovation by providing the lowest risk path to IND. It democratizes access to proven transposase-based cell line development, ensuring that scientific progress is driven by data and informed decisions rather than capital constraints.
Customer Problems | Syngene Solution |
|---|---|
a) Time Lost to Inaction • Cell Line Development (CLD) is often delayed while approvals, funding, or partnerships are finalized • These months create zero asset value, even though the program clock keeps ticking | a) Head Start That Actually Changes Outcomes By starting CLD immediately, customers gain up to a 4 month head start that translates into • Earlier access to strong IND package • Earlier clinical entry • Better leverage in partnering or fundraising discussions |
b) Concentrated Early Stage Risk • The highest technical and financial risk exists at the very beginning (CLD can represent 10-30% of pre-IND spending) • Traditional CDMO models shift this risk almost entirely onto the customer—with full upfront commitments | b) Risk Sharing by Design This is not acceleration through speed alone; it is acceleration through shared conviction. Customers move forward before certainty sets in, reducing timeline risk and increasing asset readiness. • Syngene absorbs early technical and operational risk • Customers gain progress without front loading exposure • The program signals confidence in the molecule, not just capacity availability |
c) Runway Pressure • Biotechs in particular face capital constraints that force them to choose between advancing science and preserving cash • This trade off slows progress and weakens negotiating leverage with investors or partners | c) Capital Sensitive, Flexible Commercial Models The program is structured around the biotech economics so that customers can preserve runway while still making real scientific progress. • Flexible, stage aligned payment structures • Spend aligned to meaningful development milestones • Reduced upfront financial pressure during the highest risk phase |
Distinctive features of mAb Accelerator
- Head‑start model: Rapid contracting with simple templates, resources available to begin CLD under 4 weeks from signature (saves up to ~4 months).
- Risk sharing: Syngene commits resources, capacity, and scientific effort upfront, absorbing early technical and operational risk alongside the customer.
- Flexible commercial models: Milestone based payments without upfront invoicing and clear visibility of raw materials, service and 3rd party costs. Flexible partnership models for longer work packages.
- Time to clinic: Gene‑to‑GMP in ~10 months with integrated DS and DP.
- Proven CLD platform: SynWeave™ 7–12 g/L.
- Global footprint: U.S. + India manufacturing with 50 KL SUB capacity and flexible scale up featuring 2 KL and 4 KL SUBs.
- Proven excellence: 150+ biologics programs| 25+ INDs | 250+ GMP batches
- Regulatory pedigree: FDA/EMA approvals across sites.
- ADC continuum: mAb + GMP bioconjugation under one roof to reduce supply‑chain friction.
- Fill‑finish at pace: capability up to 1M vials/day for clinical/commercial DP needs
- Sustainable operations: >80% green energy.
Gene to GMP in 9 Months
Our Gene to GMP program is more than a service, it’s a strategic alliance that aligns our capabilities with your goals. By supporting your cell line development program, we’re not just reducing your financial risk, we’re demonstrating our confidence in your molecule’s potential. Whether you’re a biotech startup or a global pharma leader, Syngene is committed to being your partner from bench to bedside.
Let’s take the first step together, because your success is our starting point.
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.
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