From lab process to pilot process, CARBOGEN AMCIS develops a safe, scalable and robust pilot process. Depending on our clients’ need for support, we develop the release analytics, ensure the scalability and robustness of the process and solve any remaining technical or sourcing related issues.

Our goal: To provide a proven pilot process that can produce safely and efficiently the first batches of APIs to support clinical trials (up to Phase III).

At a minimum you can anticipate the following outcomes as a result of your input combined with our activities:

Input

• Lab process
• Quantitative analytical data (e.g. NMR, IR, UV, MS etc.)
• IPCs

Activities

• Evaluation of scalability and robustness of the process
• Technical issues
• Safety assessments
• Sourcing
• Analytical method development for release

Output

• GMP: Master Operation Record (MOR)
• GMP: validated method for release
• Preclinical GMP: detailed report
• Samples and/or references
• g to kg amounts