USP Education Course: Bioassay/Method Developments · USP Education is now offering a hands-on...
1
Now available – Two highly characterized Reference Standards for residual host cell DNA: CHO genomic DNA and E. coli genomic DNA with the following benefits: Learn more and order highly sensitive and specific residual genomic DNA measurement method optional protein extraction procedure to minimize sample matrix effects no kit required primer and probe sequences provided flexibility in labeling oligonucleotides Standards NEWLY RELEASED: Residual Host Cell DNA Call for comments on the new General Chapter <1042> Cell Banking This chapter, which provides users with practical guidelines and current best practices regarding the clonal derivation, production, characterization and qualification, and resupply of cell banks used for manufacturing biological drug products, is now published in PF 44(6). The 90 day commenting period closes on March 31, 2019. Submit comments Share your comments on the following General Chapter revisions and help inform standards development by March 31, 2019: <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products: Additional sections have been added to address regulatory considerations and the impact of ancillary material quality on product quality. Other revisions include topics such as identification and sourcing, risk management, and ancillary materials residual level assessment and removal. <1046> Cellular and Tissue-Based Products: This chapter includes an overview of considerations for the development of cell- based advanced therapies and tissue-based products. Revisions have been made throughout the chapter such as changes to the chapter title, donor eligibility, potency, dose- defining assays, and administration to patients. <1047> Gene Therapy Products: Revisions to this chapter include removal of references to Pharmaceutical Compounding- Sterile Preparations <797>, changes to the definition of liposome, and updates to the FDA Guidance Documents list. Share your comments Call for comments: Submit your feedback before March 31, 2019 USP Education is now offering a hands-on bioassay laboratory-based course that focuses on USP General Chapters <1030>, <1032>, <1033> and <1034> along with laboratory execution of bioassay procedures. In this highly interactive course, participants will learn key concepts of in vitro bioassays, including use of relevant terminology, best practices, design, development, validation, post-validation, analysis, interpretation and reporting of results. It’s a great opportunity for those who wish to understand the best practices for analysis and consistent interpretation of data obtained from method development and validation. Scientists also gain hands-on laboratory experience and learn about the application of appropriate statistical tools for data analysis. Learn more Thursday, March 14, 2019 | 12:00 pm Eastern The webinar will focus on challenges related to measurement of process and product related impurities with a case study to illustrate the principles. Development of specifications within a product life cycle framework will be included with considerations that are helpful at each step. Regulatory and compendial guidance will be identified so that participants are aware of relevant references. A significant portion of the webinar will focus on challenges related to measurement of process and product related impurities with a helpful case study to illustrate the principles. The webinar will be led by Dr. Michael Verlander, a well-known expert in this field, who has successfully brought many synthetic peptides through the development and approval process. Register today USP Education Course: Bioassay/Method Developments USP-sponsored Webinar: Evolution of Specifications and Analytical Methods During Synthetic Peptide Drug Development Education Opportunities USP held their annual two day workshop on Therapeutic Peptides-Regulations, Standards and Quality on November 5-6, 2018. On the first day speakers from organizations such as- Eli Lilly, FDA, Polypeptide, MIT and Arecor covered topics pertaining to regulatory considerations, manufacturing and control strategy considerations, and analytical technology. On the second day speakers from Sanofi, USP, Hikma, Neon Therapeutics, Immatics and other organizations presented on bioassay topics. Topics included cell-based assays in compendial standards, bioassay and a phase-appropriate control strategy for synthetic therapeutic peptide APIs, peptide physical stability, and development of personal cancer vaccine NEO-PV- 01. Learn more Event highlights Peptides Workshop As part of USP’s focus on working with stakeholders in South Korea, USP conducted its first Biologics User Forum in Seoul, South Korea on November 13th, 2018. The forum was a half-day discussion on usage of USP standards and resources in the area of biologics. Strategic Customer Development Manager Mr. Ankush Sharma updated the attendees on USP’s analytical methods and General Chapters for recombinant therapeutics, USP Monographs and Reference Standards in proteins, peptides and blood products and USP’s future approach for standards for biologic products. Mr. Joseph Eaton, Senior Strategic Customer Development Manager, presented an overview of USP’s Monograph and Reference Standard development process. The forum was attended by more than 60 participants from more than 20 organizations. Korea User Forum The Protein and Peptide Therapeutics and Diagnostics Research and Quality Assurance International Workshop (PPTD) was held on October 10th, 2018 in Chengdu, China. PPTD was hosted by International Bureau of Weights and Measures, National Institute of Medicine and National Institutes for Food and Drug Control and covered three sessions: Drug Characterization, Research and QC for In Vitro Diagnostics, and Reference Standards & Regulation. The speakers came from domestic industry, academic and international organizations such as BIPM, JCTLM, USP, IFCC, NIST and NIBSC. Dr. Fouad Atouf, USP Vice President, Science – Global Biologics gave a presentation entitled, “Reference Standards for Peptides and Proteins, Value Assignment and Best Practices” as part of the Drug characterization and Quality Assurance session. PPTD attracted over 700 attendees from all over the world. PPTDS in China Regulatory considerations for personalized medicines are often related to complex scientific and implementation challenges that span the entire production and distribution process. In our current approach for developing standards for biologics—which includes personalized therapies—we are helping to meet some of these challenges by prioritizing the development of standards for raw materials, as well as performance standards, which apply to classes of biologics rather than individual products. Read more Blogs New blog: "Role of Standards in Personalized Medicine" View newsletters Read our other newsletters USP continues to lead the way in biologics with new Reference Standards, education opportunities and global outreach. Read all about our efforts to advance the field in this newsletter. In this issue: – Details on the newly released Reference Standards for measurement of residual host cell DNA – Upcoming education opportunities – New blog: "Role of Standards in Personalized Medicine" – Highlights from past workshop and meetings Contact Us | Code of Ethics | Legal Notices | Privacy Policy | Terms of Use | © The United States Pharmacopeial Convention Biologics at USP | Blog | Products | Biologics Standards | Newsletter | Executive Summaries |
Transcript of USP Education Course: Bioassay/Method Developments · USP Education is now offering a hands-on...
Now available – Two highly characterizedReference Standards for residual host cellDNA: CHO genomic DNA and E. coligenomic DNA with the following benefits:
Learn more and order
highly sensitive and specific residualgenomic DNA measurement methodoptional protein extraction procedure tominimize sample matrix effectsno kit requiredprimer and probe sequences providedflexibility in labeling oligonucleotides
Standards
NEWLY RELEASED: Residual Host Cell DNA
Call for comments on the new GeneralChapter <1042> Cell BankingThis chapter, which provides users withpractical guidelines and current best practicesregarding the clonal derivation, production,characterization and qualification, and resupplyof cell banks used for manufacturing biologicaldrug products, is now published in PF 44(6). The 90 day commenting period closes on March31, 2019.
Submit comments
Share your comments on the followingGeneral Chapter revisions and help informstandards development by March 31, 2019:
<1043> Ancillary Materials for Cell, Gene,and Tissue-Engineered Products: Additionalsections have been added to address regulatoryconsiderations and the impact of ancillarymaterial quality on product quality. Otherrevisions include topics such as identificationand sourcing, risk management, and ancillarymaterials residual level assessment andremoval.
<1046> Cellular and Tissue-Based Products:This chapter includes an overview ofconsiderations for the development of cell-based advanced therapies and tissue-basedproducts. Revisions have been madethroughout the chapter such as changes to thechapter title, donor eligibility, potency, dose-defining assays, and administration to patients.
<1047> Gene Therapy Products: Revisions tothis chapter include removal of referencesto Pharmaceutical Compounding- SterilePreparations <797>, changes to the definition ofliposome, and updates to the FDA GuidanceDocuments list.
Share your comments
Call for comments: Submit your feedback before March31, 2019
USP Education is now offering a hands-on bioassay laboratory-based course that focuses on USPGeneral Chapters <1030>, <1032>, <1033> and <1034> along with laboratory execution of bioassayprocedures. In this highly interactive course, participants will learn key concepts of in vitro bioassays,including use of relevant terminology, best practices, design, development, validation, post-validation,analysis, interpretation and reporting of results. It’s a great opportunity for those who wish to understandthe best practices for analysis and consistent interpretation of data obtained from method developmentand validation. Scientists also gain hands-on laboratory experience and learn about the application ofappropriate statistical tools for data analysis.
Learn more
Thursday, March 14, 2019 | 12:00 pm Eastern
The webinar will focus on challenges related to measurement of process and product related impuritieswith a case study to illustrate the principles. Development of specifications within a product life cycleframework will be included with considerations that are helpful at each step. Regulatory and compendialguidance will be identified so that participants are aware of relevant references. A significant portion of thewebinar will focus on challenges related to measurement of process and product related impurities with ahelpful case study to illustrate the principles.
The webinar will be led by Dr. Michael Verlander, a well-known expert in this field, who has successfullybrought many synthetic peptides through the development and approval process.
Register today
USP Education Course: Bioassay/Method Developments
USP-sponsored Webinar: Evolution of Specificationsand Analytical Methods During Synthetic Peptide DrugDevelopment
Education Opportunities
USP held their annual two day workshop on Therapeutic Peptides-Regulations, Standards and Quality onNovember 5-6, 2018. On the first day speakers from organizations such as- Eli Lilly, FDA, Polypeptide,MIT and Arecor covered topics pertaining to regulatory considerations, manufacturing and control strategyconsiderations, and analytical technology. On the second day speakers from Sanofi, USP, Hikma, NeonTherapeutics, Immatics and other organizations presented on bioassay topics. Topics included cell-basedassays in compendial standards, bioassay and a phase-appropriate control strategy for synthetictherapeutic peptide APIs, peptide physical stability, and development of personal cancer vaccine NEO-PV-01.
Learn more
Event highlights
Peptides Workshop
As part of USP’s focus on working withstakeholders in South Korea, USP conducted itsfirst Biologics User Forum in Seoul, SouthKorea on November 13th, 2018. The forum wasa half-day discussion on usage of USPstandards and resources in the area ofbiologics. Strategic Customer DevelopmentManager Mr. Ankush Sharma updated theattendees on USP’s analytical methods andGeneral Chapters for recombinant therapeutics,USP Monographs and Reference Standards inproteins, peptides and blood products andUSP’s future approach for standards for biologicproducts. Mr. Joseph Eaton, Senior StrategicCustomer Development Manager, presented anoverview of USP’s Monograph and ReferenceStandard development process. The forum wasattended by more than 60 participants frommore than 20 organizations.
Korea User Forum
The Protein and Peptide Therapeutics and Diagnostics Research and Quality Assurance InternationalWorkshop (PPTD) was held on October 10th, 2018 in Chengdu, China. PPTD was hosted by InternationalBureau of Weights and Measures, National Institute of Medicine and National Institutes for Food and DrugControl and covered three sessions: Drug Characterization, Research and QC for In Vitro Diagnostics,and Reference Standards & Regulation. The speakers came from domestic industry, academic andinternational organizations such as BIPM, JCTLM, USP, IFCC, NIST and NIBSC. Dr. Fouad Atouf, USPVice President, Science – Global Biologics gave a presentation entitled, “Reference Standards forPeptides and Proteins, Value Assignment and Best Practices” as part of the Drug characterization andQuality Assurance session. PPTD attracted over 700 attendees from all over the world.
PPTDS in China
Regulatory considerations for personalizedmedicines are often related to complexscientific and implementation challengesthat span the entire production anddistribution process. In our currentapproach for developing standards forbiologics—which includes personalizedtherapies—we are helping to meet some ofthese challenges by prioritizing thedevelopment of standards for rawmaterials, as well as performancestandards, which apply to classes ofbiologics rather than individual products.
Read more
Blogs
New blog: "Role of Standards in PersonalizedMedicine"
View newsletters
Read our other newsletters
USP continues to lead the way in biologics with new Reference Standards, education opportunities and global outreach. Read all about our effortsto advance the field in this newsletter.
In this issue:– Details on the newly released Reference Standards for measurement of residual host cell DNA– Upcoming education opportunities– New blog: "Role of Standards in Personalized Medicine"– Highlights from past workshop and meetings
Contact Us | Code of Ethics | Legal Notices | Privacy Policy | Terms of Use |
© The United States Pharmacopeial Convention
Biologics at USP | Blog | Products | Biologics Standards | Newsletter | Executive Summaries |
