Patrick Gay , manager of PR & D , and Julien Perron , senior chemist , at Carbogen Amcis , explain why investments in advanced GMP kilo lab facilities are essential
Beyond the lab : Efficient strategy for kilogram-scale HPAPI handling
Patrick Gay , manager of PR & D , and Julien Perron , senior chemist , at Carbogen Amcis , explain why investments in advanced GMP kilo lab facilities are essential
Highly potent APIs ( HPAPIs ) are pharmacologically active compounds that elicit a biological response at a very low dose . A compound is generally classed as highly potent if it has an occupational exposure limit ( OEL ) of ≤100 µ g / m 3 . These substances are used in formulations for high-potency drugs , especially those specifically targeting diseased cells .
About 30 % of the products under development are HPAPIs and an increasing number of molecules have complex structures . HPAPIs are crucial in drug development , notably in oncology . These compounds are known to have high activity even at low dosage , requiring special care for handling and manufacturing .
According to Persistence Market Research projections and Mordor Intelligence , the HPAPIs market is projected to expand significantly at a CAGR of 10.9 %, reaching a valuation of $ 65.1 billion by 2033 , up from $ 26.85 billion in 2024.1 , 2 The key drivers are the high demand rising in chronic diseases such as cancer , resulting from the growth in population .
The biggest growth is expected to be in the US , followed by the EU . The expectation is this rate will continue to rise along with the increasing number of niche products , such as linker payloads . In some analyses , HPAPIs could eventually become 40-50 % of all approved drugs .
Need for safety measures
Because of their high activity and corresponding low daily dose , the required amount of HPAPI for early
Walk-in fume hood fully integrated with a glovebox
stages is typically small , usually at the kilogram scale . Manufacturing HPAPIs for development projects and the production of small (< 1 kg ) GMP batches entails a certain number of constraints and required expertise .
HPAPI handling requires safety measures to be taken to protect workers , including category-specific measures to control occupational hygiene . In addition , specific GMP risks for patient safety must be considered .
Swiss CDMO Carbogen Amcis handles HPAPIs for development projects and production of small GMP batches , especially at the Vionnaz site . When assessing substances , the company uses occupational exposure bands ( categories ) from 1 up to 5 .
Substances that are assigned to Category 3 and above ( OEL3 < 10 µ g / m 3 ) are designated as ‘ highly active ’ or ‘ highly potent ’. These substances must be handled with suitable containment measures . Solid handling in particular must be conducted in HP laboratories exclusively , using fit-forpurpose fume hoods .
Recent additions
In 2023 , to respond to increasing demand for HPAPIs , Carbogen Amcis upgraded a lab-scale HPAPI production facility to handle batches ranging from 100 gm to 1 kg . Our safety protocols and handling procedures adhere to the highest standards , ensuring adequate containment down to an OEL of 10ng / m 3 .
The facility features a walk-in fume hood ( WFH ) fully integrated with a glovebox ( both pictured ) for safe HPAPI processing . Both are fully qualified .
The fume hood is designed for liquid handling within an ATEX-compliant environment and accommodates two 20-litre reactors . 3 Positioned behind the glovebox , it includes pass-through connectors for secure liquid transfer between the two systems . The
22 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981