USP Superior Manufacturing Know-how Lab Opens in Richmond, Virginia
ROCKVILLE, Md., Dec. 12, 2022 /PRNewswire/ — The U.S. Pharmacopeia (USP) in the present day introduced the opening of the USP Superior Manufacturing Know-how Lab in Richmond, Virginia as a part of its launch of a collection of R&D analytical options. These analytical lab providers will assist the efforts of drug producers searching for to undertake superior manufacturing applied sciences together with pharmaceutical steady manufacturing (PCM) as a technique to assist improve geographic range in pharmaceutical manufacturing and assist medicines provide chain resilience.
“Whereas presenting potential benefits, adopting new applied sciences comes with challenges. In the case of PCM, not all corporations have entry to the experience, sources, or capability to develop and qualify new in-line, at-line, and off-line analytical strategies required for the brand new manufacturing processes,” stated Dennis Corridor, USP Vice President, Superior Manufacturing Applied sciences. “USP’s analytical lab service choices can assist fill the hole, and help producers to additional drive innovation, include manufacturing prices, and optimize efficiencies in staffing and sources whereas facilitating market entry to high quality medicines made with PCM. Our facility in Richmond gives capability to assist these very important providers.”
“Lowering technical and coaching obstacles to adoption of superior manufacturing applied sciences like PCM will assist strengthen resilience by permitting medicines to be made in additional locations. This diversifies sources of provide and strengthens the medicines provide chain,” stated Ronald T. Piervincenzi, Ph.D., CEO of USP. “Our new analytical laboratory service choices prolong USP’s functionality to help producers contemplating the adoption of PCM, and can assist guarantee availability of trusted, high quality medicines made with PCM alongside these made with conventional batch manufacturing expertise.”
USP R&D Analytical Options
The brand new R&D analytical options will include analytical lab providers that leverage USP’s in-house scientific experience and state-of-the-art services on the USP Superior Manufacturing Know-how Lab in Richmond, in addition to USP’s headquarters facility in Rockville, Maryland. These capabilities can be used to characterize supplies, and develop and qualify strategies to assist guarantee the standard of medicines made with PCM. Areas of focus will embrace (however not be restricted to):
- Drug assays, together with stability-indicating checks
- Strategies to manage impurities (together with mutagenic, course of, and unknown impurities, in addition to residual solvents)
- Cleansing validation
- Purity evaluation
- Materials isolation, identification, and characterization
- Spectrometric and different course of analytical expertise purposes
For extra data on USP R&D analytical options, click on right here.
Lowering Boundaries To PCM Adoption
USP’s deal with R&D analytical options and high quality measurements particular to PCM is a part of a broad vary of actions designed to handle the challenges of PCM adoption and assist bolster medicines provide chain resilience.
Consulting providers supplied by Pharmatech Associates, Inc., a USP Firm, can assist producers via the decision-making course of and challenges associated to PCM adoption. Pharmatech Associates consulting providers – which function independently from USP’s standards-setting processes – present enterprise, technical, and regulatory methods, tools and course of design providers, in addition to workforce coaching to producers searching for to pursue PCM and different superior manufacturing applied sciences. For extra on Pharmatech Associates, click on right here.
USP can be working with companions and stakeholders to handle PCM data gaps via academic applications; create a web-based steady manufacturing Information Heart; and launch a circulation chemistry R&D lab to analyze novel routes of synthesis for energetic pharmaceutical components utilizing PCM and develop new analytical methods to make sure product high quality. As well as, USP is exploring the place there’s a want and alternative to develop new PCM tips, greatest practices, and high quality requirements. It’s our hope that this may finally assist stakeholders carry extra high quality merchandise to marketplace for the advantage of sufferers.
When successfully utilized, PCM has the potential to permit flexibility and effectivity in manufacturing; decrease manufacturing prices; lower environmental footprints; speed up manufacturing and scale-up in response to emergencies; and scale back potential high quality points via real-time monitoring. Consequently, the expertise has gained elevated consideration from business and policymakers lately as a technique to assist develop home manufacturing of important medicines within the U.S. and different nations, guard towards potential drug shortages, and strengthen the medicines provide chain.
For extra data on these and different USP actions geared toward bolstering the medicines provide chain and addressing ongoing vulnerabilities, click on right here.
Pharmaceutical Steady Manufacturing
PCM entails a steady circulation of supplies via a course of pipeline – through which two or extra unit operations are instantly related – and the sequential transformation of these supplies. The method output – reminiscent of an energetic pharmaceutical ingredient or drug product – is collected because the enter supplies are being fed in, and the whole course of occurs in a single facility.i To be taught extra about PCM, watch the video right here.
USP is an impartial scientific group that collaborates with the world’s high consultants in well being and science to develop high quality sources and requirements for medicines, dietary dietary supplements and meals components. By means of our sources, requirements, advocacy and schooling, USP helps improve the supply of high quality medicines, dietary supplements and meals for billions of individuals worldwide.
i Worldwide Council for Harmonisation guideline Q13 on steady manufacturing of drug substances and drug merchandise, 2021.
E-mail: [email protected]
SOURCE U.S. Pharmacopeia