Our labs are by design, flexible and arranged to achieve optimal results
Alcami’s chemists and scientists have more than 30 years experience developing analytical methods and procedures to support drug development and manufacture. Equipped with First-in-Class lab and process analytical technologies, Alcami’s labs are by design, flexible and arranged to achieve optimal results in an efficient and timely manner.
Your Timeline is Our Timeline.
Alcami strives to set the standard for excellence in the contract development and manufacturing organization (CDMO) space. Our latest initiative for excellence is critical in any phase of the drug development process: timelines.
Alcami offers a broad range of analytical testing and related services including:
- Compendial monograph testing per the USP, EP, BP, JP, FCC, ACS
- Method transfer, verification and validation studies
- Drug substance reference standard characterization studies
- Analytical method development and validation studies for small molecules and biopharmaceuticals
- Active pharmaceutical ingredient characterization
- Heavy metals, trace metal impurities and elemental impurities testing
- Residual solvents as per USP <467>
- Container and closure system integrity testing
- Disinfectant qualification and disinfectant efficacy studies
- Element impurities per USP <232>, <233>