Non-GMP / CGMP Manufacturing

Our non-GMP / CGMP manufacturing service offers the flexibility to accommodate your development strategy, with the ability to handle a wide range of batch sizes to meet your evolving needs. Leveraging our operational excellence and integrated testing capabilities, we provide a seamless journey beyond your Investigational New Drug (IND) application, ensuring a smooth and efficient path through the clinical trial process. Whether you require small-scale pilot batches or larger commercial-ready production, our experienced team is equipped to support you at every step, confidently helping you navigate the complexities of clinical manufacturing.

Non-GMP Clinical Manufacturing

We help generate toxicology study materials and evaluate processes for GMP scale-up manufacturing. To accelerate timelines while minimizing risks, we also offer a pool-based toxicology material generation service
  • Drug Substance
    • Material production in 50 L/200 L single-use bioreactor
    • AKTA process and UF/DF equipment to confirm scale-up and robustness of the entire downstream process
  • Drug Product
    • Aseptic manual filing for pre-clinical studies 2R-50R with flip-cap crimping

CGMP Clinical Manufacturing

Our small-scale manufacturing facility has the same best-in-class characteristics and equipment as our large-scale capacity for efficient scale-up manufacturing as the therapeutic progresses towards regulatory approval.

Drug Substance

Drug Product

  • • Filling rate: up to 600 vials/hr for DP#3 (up to 12,000 vials/hr for DP#1, up to 18,000 vials/hr for DP#2)
    • Filling range: 0.2 ml - 100 ml for DP#3 (0.1 ml - 100 ml for DP#1&2)

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