Syngene undertakes manufacturing of both small molecules and biologics.
Syngene has capabilities for current Good Manufacturing Practices (cGMP) manufacturing from benchtop volume to commercial scale. Since 2015, we have generated around 150 metric tons of materials for various projects. We offer end-to-end solutions from GLP-Tox batches to clinical supplies, scale up, launch and commercial manufacturing.
Key features of our small molecules facilities:
• Manufacturing of Regulatory starting materials (RSMs), APIs, HPAPI, NCEs & Novel advanced intermediates
• Broad range of reactors (stainless steel, glass lined, hastelloy) and capabilities to handle varied chemistries (asymmetry catalysis, halogenation)
• High potency expertise (cytotoxic, cytostatic compounds up to 0.1 μg/m³ – 8h OEL)
• Hydrogenator for highly acidic/basic reactions with capacity up to 4 KL volume and 20 bar rating
• High vacuum (< 10 Torr) & high temperature (140°C) distillations
• 12 KL cryogenic reactor operating within a temperature range of -90°C to 140°C
• PMDA (commercial) and USFDA (RSM) approved manufacturing facilities
Syngene is 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).
Our biologics Manufacturing facility caters to multi-product production campaigns simultaneously, based on single-use technology platform. It is designed to support clients during long -term commercial manufacturing campaigns. Our facility has a wide range of sophisticated and high-end equipment with rich experience in handling cell culture-based products.