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
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- Drug Substance
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- 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
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- Drug Product
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- 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
- sP1
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 40 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
- sP2
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 50 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
- sP1
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 40 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
- sP2
- FlaskCulture
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- 20 L (N-3) (nominal volume) Wave bioreactor
- 40 L (N-2) (w.v) Seed bioreactor
- 200 L (N-1) (w.v) Seed bioreactor
- 1000 L (N) (w.v) Production bioreactor
Drug Product
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- • 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)
