There is a continuing trend toward pharmaceutical companies developing highly active and highly targeted drugs that provide therapies for specific diseases and conditions. Many of these drugs are potent and therefore require complex chemistry and special facility requirements during their development. Pharmaceutical companies who decide to outsource the development and/or manufacturing of their potent drugs, APIs and compounds need to select a partner that posses the experience and special requirements to ensure their project’s success.

Cedarburg Hauser Pharmaceuticals has the experience and expertise with successfully developing and manufacturing potent compounds and potent APIs.

In addition to meeting the standard GMP requirements associated with manufacturing any API for use in clinical trials, we have the additional layers of operational complexity required to develop and manufacture potent APIs.

We have the processes and procedures to address…

Environmental Controls

Environmental containment issues and worker exposure limits – development and production suites with dedicated HVAC systems with single air pass and controls and cascading pressuring differentials between the labs and hallways to prevent cross-contamination

Laboratory Controls

Equipment cleaning validations at extremely low levels
Laboratory handling and control
Special laboratory equipment must be used, properly isolated and cleaned
Keycard security system

Material Handling Controls

Inventory management, control and disposal
Special handling requirements – receiving, transferring, packaging and shipping

Documentation

Special documentation surrounding the development, manufacturing, receiving and shipping of potent compounds and potent APIs

Training

All laboratory staff are thoroughly trained on working with potent compounds and hazardous materials
All receiving and shipping staff are rigorously trained on handling potent compounds and hazardous materials

Cedarburg Hauser has experience developing and manufacturing the following potent APIs…

Testosterone derivatives
Irinotecan conjugates
Paclitaxel and conjugates
Doxercalciferol
Becocalcidiol
Exemestane
Various client proprietary potent compounds

Next Steps…

If you are developing a potent drug / API we would like to talk with you about how Cedarburg Hauser can use our experience and expertise to help you make your project a success. This e-mail address is being protected from spambots. You need JavaScript enabled to view it now to discuss your project!