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Standards
Triptorelin

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 high potential for utility by the industry. USP has collaborated with a sponsor to develop a new monograph, Triptorelin Pamoate, which has been published in Pharmacopeial Forum PF43(3). In line with USP’s mission of promoting public health and ensuring quality of medicines, the the monograph includes multiple orthogonal identification methods as well as multiple chromatographic methods to determine content and impurities. In parallel to publication of the monograph, USP has completed collaborative testing of four new Reference Standards that support the monographs, the API, and three related impurities.

•  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

New Reference Standards

 

To learn more about USP Reference Standards, please click on the following link.

 

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Residual DNA Reference Standards

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>
Donation of materials for development of performance standards for biologics

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 performance of analytical methods and manufacturing processes. We are particularly interested in donation of purified host cell proteins that may be used to support characterization and quantitation of host cell proteins that may be present in a therapeutic product. Please contact USP to determine if your materials can be used for development of performance standards. In addition to contributing to public standards and public health, your donation will also be recognized by the USP Donor Recognition Program.

 

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Feature
USP’s focus on Biologics in South Korea

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.

  • Early in 2018, USP met with Korean regulatory agency-Ministry of Food and Drug Safety, Korea Drug Research Association, and Korea Health Industry Development Institute as well as local biologics manufacturers to explore collaborative opportunities.
  • This past May, Ranjan Chakrabarti, Vice President and Head of Global Biologics Lab and Standards, spoke on the “Role of Standards for Bio Therapeutics and USP Approach” at the 7th Annual Biologics Manufacturing Korea 2018.
  • 28 participants from more than 15 biopharmaceutical companies participated in a science forum in June 2018
    to discuss USP’s plans in the areas of vaccines, peptides, monoclonal antibodies (mAbs), and Heparin.
  • Later in June, Ron Piervincenzi, USP’s CEO, conducted a presentation on the USP Perspective in Biologics during the plenary session of the 2018 Global BIO Conference.

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!

 

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News
China Peptide workshop: April 2018

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.

CASSS
As more cell therapies fill the development pipeline, establishing standards is increasingly critical to ensure consistent quality for patients. Standards and quality for cell therapies were key topics at the inaugural 2018 CASSS Cell & Gene Therapy Products Symposium. USP’s VP of Biologics, Dr. Fouad Atouf, spoke on the importance of the quality of raw materials in manufacturing of advanced therapies and Dr. Rebecca Potts, USP Associate Scientific Liaison discussed recent developments in standards for cell therapies.  
Bioprocessing Summit

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 application of standards and best practices for advanced therapies as well as strategies for evaluating critical components of a cell therapy manufacturing process. In addition to the need for risk assessment strategies for qualification of raw materials and cell culture supplements, excipients and other formulation components must meet the required quality to ensure consistency in manufacturing and subsequently the quality and safety of finished cell therapy products.

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.

 

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USP IFPMA Roundtable on Performance Standards Development

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.

 

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