Editorial: Analytical Testing - Contractors Take on the Challenge of Complex Molecules

Alcami contributed to a special feature in Drug Development and Delivery magazine titled "Analytical Testing- Contractors Take on the Challenge of Complex Molecules." The article highlights some of the analytical testing services that leading contractors offer aimed at the increasing complexities of today’s pharmaceutical pipelines.

Alcami: Playing a Role in Opioid Product Formulations

Alcami offers a range of services with extensive experience in development and validation utilizing various detection techniques. For peak identification specifically, mass spectrometry and NMR equipment, as well as standard characterization, are deployed. Moreover, Alcami has cleaning validation experience, particularly in its oral solid dose and sterile manufacturing facilities. Alcami also provides complete environmental monitoring and water analysis services. Alcami assists with API structural characterization, drug product formulation, and full-on method development/validation work in support of a product’s lifecycle and production. At present, Alcami has more than 265 products in its portfolio. Alcami’s API portfolio includes more than 90 clinical and 20-plus specialty commercial and generic products, and its drug portfolio encompasses more than 90 clinical and 65-plus specialty commercial and generic products.

Alcami’s current contribution to the bioanalytical and biopharmaceutical space focuses primarily on antibody, protein, and peptide evaluations featuring cell-based bioassays, residual DNA analysis, particle identification, and extractable/leachable programs. “In the biotech area, we have invested in technologies and capabilities, including new qPCR equipment,” says Director of Biotechnology for Alcami Vernon K. Dailey.

In the past year, one of Alcami’s standout achievements, according to Jason T. Spacek, Director of Commerical Development for Laboratory Services, Alcami, was an analytical testing partnership that led to a client’s successful submission of an opioid product. “As the opioid abuse epidemic worsens and becomes more prevalent in our communities, Alcami works to combat the crisis by employing an experienced abuse-deterrence team. This highly-skilled unit ensures opioid product formulations can stand up to the harshest abuse conditions and regulatory scrutiny.”