Triptorelin, a peptide hormone that is used to treat advanced prostate cancer, is widely administered at almost 7.5 million doses globally in 2015*. While only one manufacturer is approved in the US, there are many manufacturers globally in various stages of development, so the development of a public standard to support the quality of this therapy has
• Triptorelin Acetate RS (catalog #1696131)
• Triptorelin Related Compound A (catalog #1696110)
• Triptorelin Related Compound B (catalog #1696128)
• Triptorelin Related Compound C (catalog #1696142)
USP expects to release these new Reference Standards for the first time later in the coming months. For further information about these standards and other USP proposals, please click on the link below.
* Source: IMS MIDAS data
To learn more about USP Reference Standards, please click on the following link.
During downstream recombinant bio-processing, biologics manufacturers must ensure adequate removal of process impurities such as residual DNA remaining from the host cell. USP is developing two new genomic Reference Standards to support residual host cell measurements from therapeutic proteins produced in either Chinese Hamster Ovary (CHO) or E.coli cells. These Reference Standards are associated with the validated qPCR methods which were detailed in the USP General Chapter <509> Residual DNA Testing proposed in PF42(5).
Download complimentary copy of USP General Chapter <509>
Help us continue to support the development and production of quality biotherapeutics with new quality standards. We welcome your donation of materials to be used to develop performance standards which monitor
While other parts of Asia are hubs for small molecule active South Korea has become a global leader in biopharmaceutical manufacturing. The following are just some of the ways that USP is engaging with stakeholders in South Korea to support their production of consistent, high-quality biotherapeutics.
An upcoming User Forum in November is the first of many opportunities for biopharmaceutical manufacturers in South Korea to collaborate with USP to address the challenges of consistency and quality in biologics production. Look for updates in the next newsletter!
This year, USP achieved a major milestone in China with its first Biologics workshop in China, with more than 250 attendees. Experts from USP, US FDA, NIFDC, local peptide manufacturers, local biopharmaceutical manufacturers & academia participated. Select senior leaders participated in a Stakeholder Meeting to discuss the need for quality standards for peptide impurities and expressed an interest in collaborating with USP on standards for impurities. After the workshop, USP staff visited the Taiwan FDA to discuss potential training and collaboration opportunities.
Technologies continue to advance at unprecedented rates, presenting new bioprocessing challenges. At the recent Bioprocessing Summit, leadership from USP’s Biologics team discussed quality-related topics important to the bioprocessing community.
USP’s VP of Biologics, Dr. Fouad Atouf spoke about
Dr. Maura Kibbey, Director, Global Biologics at USP, shared new initiatives in host cell protein analytical methods, including an update on USP standards to support characterization and measurement of specific host cell proteins (HCPs). To minimize safety concerns and ensure the quality of the drug substance, impurities such as HCPs must be cleared from recombinant biotherapeutics. HCP ELISAs can miss specific proteins that may persist, and therefore the use of orthogonal methods has increased. USP’s HCP Expert Panel developed General Chapter <1132> to describe best practices for measurement of HCPs.
Dr. Kevin Carrick, Director, Science and Standards, Global Biologics at USP, discussed strategies for monitoring impurities in biomanufacturing processes. Impurities range from process-related, such as host cell DNA, host cell proteins and particulates, to product-related, such as degradants, precursors and aggregates. Regardless of their origin, impurities must be monitored and controlled to ensure the quality of the drug substance and drug product. USP standards can be part of an effective approach for monitoring impurities.
This past May, USP and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) cosponsored a roundtable with analytical scientists and compendial representatives from eight major biopharmaceutical companies to discuss performance standards development. Performance standards are important to the industry as they support quality control, analytical development, process development and comparability of assays and materials between companies. Read more about the outcomes from the roundtable here.