Highly Potent API Supply
Highly Potent APIs for Pre-clinical, Clinical and Commercial Use
There is increased demand in the market for highly potent API due to increased oncology research and more targeted treatments across several indications. This is why the Dishman Carbogen Amcis Ltd Group has invested in world-class capabilities to address the oncology and other highly potent compound therapy markets.
The Group has a strongly differentiated set of in-house capabilities in the HiPo API arena, underwritten by a consolidated project management capability to take customers from preclinical stages to commercial manufacturing of APIs I and clinical Ph2 parenteral dosage form capabilities.
Dishman Carbogen Amcis Ltd has invested around USD20 million at our Bavla India campus, creating a dedicated and segregated 4300 m2 state-of-the-art facility completed with development labs, kilo lab, and large-scale commercial plant. The plant incorporated global best practices in potent compound handling and was designed and constructed by an internal global team. The facility has scale capability from mg’s to high kg scale for manufacturing API at the highest potency levels.
Dishman Carbogen Amcis Ltd has extensive experience and substantial capability in helping customers bring highly potent drugs to patients. We facilitate the effective and safe development and routine commercial manufacture of APIs under cGMP, with upstream integration to intermediates and key raw materials (KRMs) to manage supply chain risk and product life cycle management. All capabilities are underpinned by a world-class occupational health system for product and personnel protection.
Our facility utilizes fully closed systems providing the high level of barrier containment required to manufacture highly potent products in a safe and ecologically protected manner.
- Experienced and highly skilled, dedicated workforce.
- FDA approved GMP facility
- R & D labs, kilo lab, and dedicated QA / QC facility
- We can handle an OEL below 1μg/m3 (containment down to category 4)
- 2 Independent manufacturing Cells (Cells α and β) of 3,200L each, with 630 to 1,600L vessels
- 5 to 200kg batch size
- Process transfer and manufacturing support labs
Fully contained operations
All containment facilities are designed based on a containment concept utilizing barrier isolation technology and Rapid Transfer Ports (RTPs) and a strict zone concept with pressure cascades, airlocks, and access controls. This allows the safe handling of highly potent compounds, including cytotoxics.
- 2 R&D Laboratories with isolators (containing an over-tray) under pressure cascade for the same specs/design of the chemical plant.
- All operations involving material handling are executed in isolators/glove boxes:
- charging of reactors
- discharging of filter dryers
- 3 HiPo material storage areas:
- Dedicated storage room for HiPo intermediates and raw materials Dedicated storage room for final products.
- Dedicated Cold Storage Room for potent products that need 2-8 conditions.
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