June 26, 2017

Process Chemistry

The following services are offered, using classical and modern synthetic methodologies such as chiral synthesis, transition metal-mediated cross coupling reactions and biocatalysis using commercially available enzymes (currently limited to hydrolytic enzymes such as lipases, hydrolases, and proteases, which do not require co-factor recycling):

Route scouting, process research:

We run parallel reactions to screen for reactivity and to identify alternative reactions and parameters that can be used as a starting point to design and develop more practical, safer, and cost effective routes to APIs and intermediates.

Process development and optimization:

A baseline assessment of the existing synthesis route is quickly executed to identify the weak points in the synthesis or process and define the main areas that require the most resources. In this way, efforts are expended in a balanced and efficient manner to tackle the most important development areas first. A demonstration lot is produced as needed to verify the new or improved process. Modern methodological tools such as the Design of Experiments (DoE) are used when appropriate to cover a wide experimental space with the minimum number of experiments, and thus expedite the process optimization and deliver a robust process. Safety considerations are built into the process as needed.

Critical processing parameters (CPP) evaluation:

For late stage development programs slated for process validation, we offer comprehensive CCP evaluation services that can be used as a basis to establish a robust process that can be validated. Such studies can be conducted using a DoE methodology if needed.

Technology transfer:

We offer detailed technology transfer packages for scale-up or production at third party manufacturing facilities. Furthermore, we understand that steady interactions and clear communication between key stakeholders, subject matter experts and leadership from all parties are necessary to facilitate the transfer of a new process, and so we closely work with our customers and the third party manufacturer to ensure all details necessary for a successful transfer are captured and clearly communicated.