Integrated Biologics partner – Discovery to Commercial
Following the EMA approval & zero 483 observations during the pre-approval inspection by US FDA, Syngene is ready to take up commercial operations. We offer integrated Biologics services across the drug discovery, development, and manufacturing continuum. Our work spans diverse modalities, including mAbs, bispecific, antibody fragments, recombinant proteins, subunit protein vaccines, mRNA, pDNA, etc.
Why Syngene for Biologics
30+ global customers with a team size of 360+ scientists
Global clinical and commercial supply capabilities
Robust program management for on-time and quality delivery
High titer through process intensification of up to 12 g/L
Experience in Human Health and Animal Health
Gene to GMP in 9 months
Development Services
- Cell line Development
- Developability Assessment
- Process Development
- Formulation Screening
- Analytical characterization and quality control
- Analytical method transfer or development followed by qualification
- Analytical method validation (ICH Q2R1)
- Viral testing and clearance studies
- Product Characterization:Â 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:Â Cell-based, non-cell based, in vivo, proliferation, inhibition, reporter gene, effector function, secondary signaling
- Stability studies:Â Exploratory, freeze-thaw, real-time, accelerated, and stress (forced degradation
Manufacturing Services
Mammalian (single-use systems)
- Scale:Â Multiples of 100L, 500L and 2000L
- Upstream: Shake flaks, 1-50L, ambr® 250L, perfusion ATF, Depth and polymeric filtration and centrifugation
- Downstream:Â Column Chromatography (IEX, Affinity, HIC, AKTA-Process, Explorers, and Purifiers). Up to 800 mm to 1 million columns with flow rates going up to 2000LPH
Microbial
- Scale:Â 200L and 500L stainless steel fermentors, 1000L refolding, 60cm column chromatography and 10 s.q.m tangential flow filtration
- Upstream:Â Continuous centrifuge, cell homogenizer
- Downstream:Â Chromatography systems, TFF systems
Sterile Fill-Finish facility
Syngene’s Sterile Fill-Finish facility is custom-built to meet market demand for small-scale, sterile drug products having short development timelines. As an integrated CRO/CDMO, we can formulate, fill, and finish your sterile products into pre-sterilized vials or pre-filled syringes for clinical supply. The facility offers drug product (DP) development and clinical manufacturing services for both biologics and small molecules.
Features
- Ready-to-use vials/PFS – liquid and lyophilized products (pre-sterilized vials and pre-filled syringes (PFS)
- Biologics, aqueous noncytotoxic and non-antibiotics
- Occupational exposure limit (OEL): ≥ 1 µg /m3 (noncytotoxic)
- Batch size of 500 to 25,000 vials (5L-50L)
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