As leading pharmaceutical companies continue to identify high potency APIs (HPAPI) and cytotoxic compounds as drug candidates to address critical healthcare needs, it has become a necessity to establish strong partnerships with suppliers that have the capabilities, regulatory infrastructure and experience to handle this special class of compounds. 

Cambrex has emerged as a leading supplier of contract development and manufacturing services for HPAPI and cytotoxic compounds with fully integrated development programs.  Cambrex facilities in Charles City, IA regularly handle potent compounds and generate toxicology lot quantities through full scale commercial quantities of HPAPI and cytotoxic APIs. 

Cambrex began manufacturing potent compounds in 1998 with the construction of a three story 2,380 sq. ft. HPAPI production facility in Iowa.  Additional R&D and kilo labs have supported continued growth of this offering at the Cambrex site in Iowa with the following capabilities:

At Cambrex, exposure control requirements are triggered by the occupational exposure limit (OEL) which is routinely calculated and assessed for APIs. OELs are grouped into one of four occupational exposure bands (OEBs) which define general health concerns, administrative requirements, monitoring strategy, and facility design criteria. At Cambrex the development of OELs and the assignment of OEBs are conducted by our occupational health professionals. In instances where toxicity and health effects information is still being developed, such as for developmental API's or intermediates, an initial OEB assignment is made without a specific OEL to ensure proper interim protection. Cambrex has the capabilities to manufacture APIs in all bands, including substances with OELs of 10 nanograms per cubic meter.

Many processes require containment to ensure that people and the environment are protected from exposure to the chemicals involved. It could be the product itself or any of the raw materials or intermediates being handled that exhibits toxic or highly potent properties. Many oncology products are highly potent and fall into this category.

Cambrex has facilities that handle highly contained processes under cGMP conditions. We currently offer commercial quantities of such products and provide development services as well. Our experience in this area has prompted us to expand our capabilities and build a new kilo laboratory to further increase our capacity for small-scale production and development.