BioPhorum is complementing its reach across industry partners to facilitate the harmonization of standards and best practice. We are delighted to present agreements with the following:
Through our rigorous science and the public quality standards we set, USP helps protect patient safety and improve the health of people around the world. USP is an independent, scientific nonprofit organization focused on building trust in the supply of safe, quality medicines. We are working to strengthen the global supply chain so that the medicines people rely on for health are available when needed and work as expected.
Collaborating for success
BioPhorum and U.S. Pharmacopeia sign a letter of intent to accelerate advances in biomanufacturing
In an environment where accelerated biopharmaceutical innovation is increasingly important, BioPhorum is enhancing its value by strengthening its voice of industry and producing consensus positions for regulations and standards development.
To offer more value to its members and industry while fostering collaboration, BioPhorum is engaging with partners to leverage each other’s capabilities and strengths through scientific, operational and regulatory alignment. For example, it is working with standards development organizations and pharmacopeias to accelerate innovation and the adoption of new technologies and scientific advances.
To this end, BioPhorum and U.S. Pharmacopeia (USP) have signed a letter of intent that outlines how the organizations will work together to advance scientific collaboration by harmonizing industry practices and incorporating these into pharmacopeial standards. This will, in turn, support the development, characterization and manufacture of biopharmaceuticals.
To achieve these objectives, BioPhorum and USP will collaborate in various ways. These include conducting joint scientific meetings and workshops to enhance awareness of challenges and best practices, and exchanging scientific experts to discuss advancing standardization.
The two organizations are already working on topics of mutual interest, including trace metals, rapid methods, bioassays and plasmid DNA used in CGT manufacture. For example, a BioPhorum/USP team delivered a successful webinar on trace metals in 2020.
Activities to date have helped establish where and how the two organizations can work together effectively. These include identifying collaborative activities such as author stimuli articles, undertaking joint knowledge-sharing workshops and experimental studies, and BioPhorum SMEs participating in USP expert panels and roundtables. The ultimate aim is to transfer long-term ownership and curation from BioPhorum to USP chapters.
“We view BioPhorum as a ‘voice of the industry’, particularly considering the collaboration’s ability to compress development lead times for new standards by several months,” said Fouad Atouf, Vice President, Science – Global Biologics for USP. “As one of the most prominent and forward-thinking global standard-setting organizations, we can strengthen our offering with the support of BioPhorum’s thought leaders and scientifically relevant content.”
As companies seek to include new technologies and methods within USP compendia to simplify their implementation, BioPhorum can facilitate this process by connecting industry with the standards-setting process. Darren Whitman, Director and a Founder of BioPhorum, added, “Formalizing our relationship with USP is a great step for both groups. The collaboration will allow us to leverage our unique capabilities and bring industry together faster and more effectively, for the benefit of all.”
Notes to editors
BioPhorum is a global collaboration of industry leaders and subject matter experts working in concert to pool knowledge, practices and ideas, which lead to results that effect change. BioPhorum’s mission is to create an environment where the global biopharmaceutical industry can collaborate and accelerate its rate of progress, for the benefit of all. Visit www.biophorum.com for more information.
USP’s mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. Visit www.usp.org for more information.
FPC@DCU – the Fraunhofer Project Centre for Embedded Bioanalytical Systems at Dublin City University – develops microfluidics-enabled “fit-for-industry” (f4i) solutions for decentralized testing of biosamples at high-technology readiness levels (TRLs).
To tackle the highly multidisciplinary challenges, FPC@DCU will actively seek technological collaboration with partners from industry, research institutes, academia, and end-user networks.
MTC (Manufacturing Technology Centre) was established to prove innovative manufacturing processes and technologies in an agile environment in partnership with industry, academia and other institutions. The MTC houses some of the most advanced manufacturing equipment in the world, creating a high quality environment for the development and demonstration of new technologies on an industrial scale. This provides a unique opportunity for manufacturers to develop new and innovative processes and technologies.