The US Pharmacopeia (USP) has opened the USP Advanced Manufacturing Technology Lab in Richmond, Virginia as part of its launch of a suite of R&D analytical solutions.

These analytical lab services will support the efforts of drug manufacturers seeking to adopt advanced manufacturing technologies including pharmaceutical continuous manufacturing (PCM) as one way to help increase geographic diversity in pharmaceutical manufacturing and support medicines supply chain resilience.

Areas of focus will include (but not be limited to):

Drug assays, including stability-indicating tests

Methods to control impurities (including mutagenic, process, and unknown impurities, as well as residual solvents)

Cleaning validation

Purity analysis

Material isolation, identification, and characterisation

Spectrometric and other process analytical technology application

USP's focus on R&D analytical solutions and quality measurements specific to PCM is part of a broad range of activities designed to address the challenges of PCM adoption and help bolster medicines supply chain resilience.