Contract Manufacturing of Highly Potent API’s

products-servicesDishman Netherlands B.V
December 13th 2013

Dishman Netherlands is a highly experienced and proficient provider of contract research and manufacturing (CRAM) services, skilled in handling Active Pharmaceutical Ingredients (APIs) including highly potent materials. Its contract manufacturing services are particularly applicable to companies up scaling from research to full production, particularly in the high potency products typical of oncology.

Capabilities
Dishman can carry out contract manufacturing at its modern certified and inspected facility at Veenendaal in central Holland. For high criticality orders, Dishman can produce to full cGMP standards with handling of high potency materials at its high containment High Potency (HiPo) production unit. The unit consists of six dedicated clean rooms with a scale of operation of up to 1 kg in addition to all standard laboratory facilities. It also accommodates three production lines.

The manufacturing operation has access to the same range of advanced technologies as Dishman’s contract research laboratory. These include:

• Continuous process saponification
• Stainless steel reactors
• Crystallization, drying, milling, mixing and solvent recovery apparatus
• Dedicated irradiation unit for photochemistry with second irradiation unit available for contract research and process development activities

Dishman also has a cGMP Quality Control laboratory, consisting of three zones with the latest state-of-the-art equipment for analyses, cleaning and sampling.

Consultancy
The company’s highly skilled activity transfer team has a proven track record of managing successful projects in liaison with customers. In particular, Dishman can provide a full synthesis route development and optimization roadmap through to full production, meeting all cGMP requirements and under inspection of relevant regulatory authorities.

Dishman offers a credible and cost effective opportunity to outsource manufacturing of Highly Potent APIs. The Dishman Group also offers HiPo APIs services from grams to commercial scale in Switzerland and India (under CARBOGEN AMCIS).

For more information about contract manufacturing of highly potent API’s, please contact Dishman NL directly