Carbogen Amcis, a Switzerland-based pharmaceutical process development and active pharmaceutical ingredient (API) manufacturing company announced a new strategic collaboration with Eirgen Pharma, an Ireland-based company that specializes in the manufacturing of solid-dose high-potency products. The companies will work together to provide timely and flexible manufacturing of highly potent active ingredients and solid oral-dose products for the treatment of cancer.

"Due to the improved side-effect profiles of many new classes of highly potent API, more oral-dosage forms are being developed and product volumes are increasing. Carbogen Amcis' strategic alliance with Eirgen allows the company to provide the market with a combined service offering to reduce the number of management interfaces and improve the speed of drug development," said Charlie Johnson, high potency business manager for Carbogen Amcis. "We selected Eirgen Pharma as a preferred partner for its solid-dosage high-potency products. We value the company's strong reputation for providing quality service, using a state-of-the-art infrastructure and maintaining a strong emphasis on the safe handling of highly potent materials."

The strategic alliance with Carbogen Amcis will encompass integrated services, spanning from high-potency API supply to solid-dose packaging.

Carbgen Amcis offerings include categorization and OEL assessment, process research and development, analytical-method development and validation, manufacturing of GMP and non-GMP batches (for toxicology studies, clinical trials and commercial use), process scale-up, ICH stability studies, process validation and regulatory support.

Eirgen's offerings include formulation development, excipient-compatibility studies, specification development, pre-clinical supplies, clinical supplies and exhibit-batch manufacturing, assay and dissolution-method development as well as validation, degradation studies, cleaning verification, oral solid-dose manufacturing and packaging (tablets, capsules, bottles and blisters).

"The partnership will result in reduced time to market for our customers' highly potent drug products through streamlined project management" added Patsy Carney, managing director of Eirgen Pharma. "We're delighted to work with Carbogen Amcis, particularly as they offer our customers alternative sites for highly potent API manufacturing in India and Switzerland."