ALEXANDER M. KLUWER1, VALENTINOS MOUARRAWIS2
1. CEO, InCatT B.V., The Netherlands
2. Business development manager, InCatT B.V. The Netherlands

Abstract

Pharmaceutical innovation requires efficient production of active pharmaceutical ingredients (APIs) and the synthesis often involves one or more catalytic steps. Optimizing the catalyst and reaction conditions will result in improved product purity, yield, and safety and such optimization is often accompanied by significant cost reduction. Many companies do not have such capabilities for catalyst screening and optimization studies in-house, due to a lack of continuous need or limited resources to maintain a high-tech laboratory with high throughput testing equipment. In such case, a (pharmaceutical) company has to rely on Contract Research Organizations (CROs) for their catalyst research. Selecting an expert CRO involves assessing their effective communication, scientific knowledge, high throughput infrastructure, unbiased services, flexibility, and quality control. Addressing potential challenges with clear communication, prompt issue resolution, aligned goals, and adaptability is critical. Collaborating with an experienced CRO can accelerate market entry, reduce production costs, and drive competitiveness in the rapidly evolving pharmaceutical industry.

Developing new and innovative products is essential for staying competitive in today’s rapidly evolving pharmaceutical industry. Pharmaceutical companies must continuously innovate, developing novel therapies and improving existing treatments to meet the needs of patients. Central to this pursuit and making these new drugs available are the med-chem and process chemists, who rely on synthetic tools that allow them to efficiently access diverse structures of active pharmaceutical ingredients (APIs).

Very often, the manufacture of APIs involves at least one catalytic step (i.e. asymmetric hydrogenation, C-C couplings, etc.) in their synthetic route. Optimizing the existing catalytic process or replacing stoichiometric reactions with catalytic ones in the manufacturing process can lead to reducing costs and improving efficiency. Even small improvements in catalytic processes can lead to a significant difference in the final product, resulting in higher purity, increased yield, and improved safety.

Large pharmaceutical companies have their dedicated catalyst R&D departments running the required projects, however, there are numerous ...