Integrated Biologics Partner

Discovery to Commercial

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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

Manufacturing Services

Mammalian (single-use systems)

Microbial

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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