Potent Compound Development & Manufacturing
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.
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