In the future, a major challenge for CDMOs from an analytical testing perspective is the increasing cross-section of drugs designated as highly potent active pharmaceutical ingredients (HPAPIs) – to which both small and large molecules are susceptible. HPAPIs require special containment procedures, engineering controls, and a culture of diligence with respect to individual safety. Each part of the testing process must be handled with careful consideration to minimize the potential for exposure.
Alcami is a CDMO that offers fully integrated, comprehensive analytical testing to support technologies for every stage of development. Its laboratory services platform is comprised of analytical testing and development services for small molecule and biologics drug products, as well as specialized offerings such as elemental impurities, abuse deterrence, and extractables and leachables. In addition, formulations development scientists address challenges related to new chemical entities.
Because Alcami’s portfolio touches on all phases of development, advancements in technology and regulatory requirements are closely monitored. The industry has changed drastically over the years and analytical testing has evolved with it. Control of impurities, excipient selection, and packaging safety are a few examples where increased awareness has led to higher expectations of analytical testing capabilities to satisfy regulatory requirements.
Given that the manufacturing of biologics requires the characterization of the drug substance beyond the typical impurity profile of a small molecule drug product, biologics are particularly susceptible to changes in requirements. Thus, the demand for higher resolution, sensitivity, and accuracy of classic techniques such as chromatography, mass spectrometry, and electrophoresis is an analytical imperative.
The evolution of analytical testing is not limited to specific techniques or instrumentation. It also applies to regulatory guidelines such as data integrity, infrastructure like electronic notebooks, and automated sample tracking systems for a chain of custody. Regulatory agencies expect continuous recording of the materials so that their handling can be recreated during an audit or investigation. Tolerance to this high level of scrutiny is a key indicator of a robust analytical testing portfolio.
Alcami’s regulatory expertise was an advantage for a client that needed additional support to meet rigorous FDA requirements during an NDA review to get the product to market. Alcami’s Extended Workbench solution helped the client address accelerated clinical trial and commercial launch timelines by providing a full-time equivalent (FTE), comprehensive, and customized service program. The program was designed for release and stability testing of batches for specific analytical testing requirements.
With dedicated Alcami staff to the project, it granted the client additional flexibility, freedom, and consistent control over their outsourced laboratory needs, and the product has been launched nationwide.