Advanced technologies that allow the delivery of drug substances directly to the site of action – tumour cells, infected cells, damaged organs – rather than acting systemically are leading to drugs with increased safety and efficacy. This approach also enables the use of highly potent active pharmaceutical ingredients (HPAPIs) that previously were not reasonable candidates due to their toxicity to the patient when delivered using conventional approaches.
Pharmaceutical manufacturers are in need of capacity suitable for the safe production, storage and transport of a growing range of potent compounds
Consequently, the HPAPI market is growing faster than the overall API market, and the percentage of drug candidates classified as HPAPIs is increasing. Pharmaceutical manufacturers are in need of capacity suitable for the safe production, storage and transport of a growing range of potent compounds. Contract service providers – both contract development and manufacturing organisations (CDMOs) and CMOs – can help, but drug companies should only consider partnering with firms that have a history of successfully producing and handling HPAPIs and continually investing in the most advanced safety equipment, systems and processes.
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