Develop a comprehensive control strategy ensuring the chemistry developed is readily scalable in a manufacturing environment
The foundation for all success in manufacturing begins with an open dialogue between research and development and manufacturing. From initial project onboarding until final product manufacture is complete, our development and manufacturing teams are aligned throughout the developmental process. Alcami’s product development teams are formed from a matrix of chemical research and development scientists, analytical scientists and process engineers. Phase-appropriate development through scientific excellence and the principles of Quality by Design is performed to develop a comprehensive control strategy ensuring the chemistry developed is readily scalable in a manufacturing environment.
Alcami customers understand that academically advanced scientists are essential to provide rapid and robust chemistry services to successfully support early preclinical quantities through full production at plant scale. We have established an experienced core of Ph.D. scientists to develop robust chemistry process controls. When combined with the engineering design controls from our process engineers and process characterization and detection controls developed by Alcami’s analytical scientists, your process will scale up right the first time. Because our development teams follow a project from the lab into the plant, we have the expertise to troubleshoot any possible issues that may arise during the scale-up phase.
Alcami’s reputation for providing solutions and expertise to solve our clients’ most difficult and challenging issues is unparalleled. Here are a few of the problems we consistently solve for our clients:
- Low overall yield or high dilutions
- Difficult removal of metals to ICH limits
- Removal of dangerous or hazardous reagents or intermediates
- Difficulty eliminating chromatography from an intermediate or API process
- Difficulty crystallizing an intermediate or API
- Inefficient equivalent loadings
- Fate and tolerance of impurities
- Critical Quality Attribute control
We have the equipment and expertise to incorporate design of experiments (DOE) for statistical evaluation of the design space. Through DOE, an experimental matrix is used to vary multiple parameters simultaneously to find the proven acceptable ranges as well as the optimum mid-point. This ensures a well characterized process with a high level of parametric control that results in successful scale up.
We also provide comprehensive synthetic research services aimed at scouting alternative routes to existing molecules. This can range from complete route development to targeted research on a single challenging step in a synthetic pathway.
Alcami can perform rapid throughput route scouting with automated parallel reactor platforms. This affords accelerated feasibility studies as well as gram quantities for preclinical compound evaluation. This gets you from concept to clinic faster.