As drug substance molecular complexity continues to increase, flow chemistry is becoming an essential enabling technology. Explore how flow chemistry facilitates the integration of complex synthetic methods, previously confined to research laboratories, into clinical and commercial production of Active Pharmaceutical Ingredients (APIs).
A recent project applied process improvement methodology to the process validation step. The approach defined manufacturing parameters without the expense of surplus experimentation and identified process improvements that provided an optimized, robust process in addition to an economic advantage.
The COVID-19 pandemic demanded significant pivots, and technology became critical for continued regulatory operations, including carrying out virtual inspections to assess drug safety and adherence to GMP. Key decision-makers in pharma and biotech companies were surveyed to assess their views on undertaking regulatory processes virtually.
Continuous manufacturing is becoming increasingly integrated with batch processing, resulting in a hybrid manufacturing process. Discover the exciting developments in continuous manufacturing and learn how leveraging this innovative technology can help improve manufacturing processes and discover new clinical candidates.
Storing, handling, and distributing scheduled materials requires special consideration, and partnering with an experienced manufacturer is crucial for navigating strict regulatory pathways. Cambrex holds US Drug Enforcement Agency (DEA) licenses for process research, development, manufacturing, and importation of Schedule I to IV controlled substances.
