Syngene is at the Heart of Biologics, offering integrated services across the drug discovery, development and manufacturing continuum. 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.
A Valued Partner from Start to Finish
As a fully integrated custom biomanufacturer, our solutions include mammalian and microbial capabilities for clinical and commercial supplies. We have a strong track record in terms of both experience and know-how across mABs, bispecific, antibody fragments, recombinant proteins, glycoproteins, mRNA, microbial (E. coli and Pichia) and microbiome Live Biotherapeutic Product (LBP).
Quality at the Heart of Biologics
We have well-established Quality Management Systems and Document Management Systems with Electronic Records and Electronic Signature (ERES)compliant equipment. Our facility is also equipped to handle remote audits.
Our Biologic Manufacturing facility can cater to multi-product production campaigns simultaneously based on single-use technology platform. It is designed to support our clients during long term commercial manufacturing campaigns. We have a wide range of sophisticated and high-end equipment, and rich experience in handling cell culture-based products.
- Cell line Development
- Developability Assessment
- Process Development
- Viral reduction steps and clearance studies
- Product Characterization: Mass Spectrometry, LC-MS (Glycan and product variants), MALDI-TOF, MS/MS (Ion-trap), CD, Fluorescence, SPR (Biacore), PAMAS (sub-vis), Solo VPE, Flowcam, Maurice (cIEF), HIAC
- Bioassays : Cell based, non-cell based, in vivo, proliferation, inhibition, reporter gene, effector function, secondary signaling
- Stability studies: Exploratory, freeze-thaw, real-time, accelerated and stress (forced degradation)
- Formulation Screening
- Non-GMP lab-scale manufacturing
Our biomanufacturing facility in Bangalore, India, offers end-to-to end, multiple platform technologies and cGMP manufacturing capabilities for clinical and commercial supply. We employ protocol-driven, technology transfer processes to bring in projects from customers and seamlessly integrate them into our facilities. We have received successful regulatory inspections from all key regulatory agencies.
Upstream and Downstream Processing
Mammalian : single use systems
- Scale: 200L/500L and 2000L
- Upstream: Shake flaks, 1-50L, ambr® 250L, perfusion ATF, Depth and polymeric filtration and centrifugation
- Downstream: Column Chromatography (IEX, Affinity, HIC, AKTA-Process, Explorers and Purifiers). Up to 80mm column and 2000L PH flow rate.
- Scale: 200L to 500L (SS) fermentors, 1000L refolding, 60cm column chromatography and 10 s.q.m tangential flow filtration
- Upstream: Continuous centrifuge, Cell homogenizer
- Downstream: Chromatography systems, TFF systems
The demand for sterile fill-finish services has outpaced available capacity, leading to extended wait times and delayed clinical trials for sponsors.
Syngene’s Sterile Fill-Finish facility is custom-built to meet market demand for small-scale, sterile drug products having short development timelines. Our facility offers Drug substance and Drug product development and manufacturing both large molecules.