R&D analytical solutions will include analytical laboratory services utilizing USP’s in-house scientific expertise and state-of-the-art facilities, including the USP Advanced Manufacturing Technology Lab in Richmond and USP headquarters in Rockville, Md.
USP Pharmacopeia (USP) has established the USP Advanced Manufacturing Technology Lab in Richmond, Va., as part of a suite of R&D analytical solutions to support advanced manufacturing technologies. It was announced that the opening such as continuous pharmaceutical manufacturing (PCM);
PCM is a continuous flow of materials through a process pipeline that directly connects two or more unit operations and is a continuous transformation of materials. A process output, such as an API or pharmaceutical product, is collected as input materials are added, and the entire process occurs in a single facility.
“Reducing technical and training barriers to adopting advanced manufacturing technologies like PCM will strengthen resilience by allowing drugs to be made in multiple locations. It will diversify sources of supply and strengthen the pharmaceutical supply chain,” said CEO Ronald T. Piervincenzi. USP said in a press release. “Our new analytical laboratory service will increase USP’s ability to assist manufacturers considering adopting PCM, and help ensure the availability of reliable, high-quality drugs made using traditional batch manufacturing techniques.”
R&D analytical solutions will include analytical laboratory services utilizing USP’s in-house scientific expertise and state-of-the-art facilities, including the USP Advanced Manufacturing Technology Lab in Richmond and USP headquarters in Rockville, Md.
Areas of focus that will be used to formulate materials and ensure the quality of pharmaceuticals made with PCM include:
- Drug testing, including tests that indicate stability
- Methods for controlling impurities (including mutagenic, process and unknown impurities as well as residual solvents);
- Sanitation confirmation
- Pure purity
- Isolation of material; Identification and Characterization
- Spectrometric and other process analysis technique applications.
USP focuses on specific R&D analytical solutions and quality metrics for PCM to help address the challenges of PCM adoption and strengthen pharmaceutical supply chain resilience.
In addition, USP to address PCM knowledge gaps through educational programs; Create an online continuous manufacturing knowledge center, open a chemical R&D lab to investigate synthesis routes for APIs using PCM, and develop new analytical techniques; Ensure product quality.
PCM is flexible and efficient in manufacturing; to reduce production costs; to cut environmental footprints; It has the potential to speed up and scale production in response to emergencies and reduce potential quality issues through real-time monitoring.
Source: PR Newswire
