USP & Biologics & Biotechnology Manufacturers

This one-hour, live webinar will explain the approach that USP is taking towards glycoprotein glycan analysis, based on a combination of qualitative and quantitative standards; explain the content of the three general chapters: <1084>; <210> and <212> that are being developed; and describe the reference standards that are being developed. Learn more and register.

The USP Insulin Expert Panel is charged with identifying and qualifying an appropriate cell-based bioidentity test to modernize the current Insulin monographs. Ideally, the cell-based bioidentity test will demonstrate unequivocally insulin activity for insulin and the insulin analogues as suitable replacement of the current rabbit blood glucose test. A number of cell-based bioidentity methods are currently performed by different manufacturers in the market. If your organization has interest in supporting this important modernization effort,please contact Tom Sigambirs, Scientific Liaison, at tzs@usp.org.

The purpose of the simulator is to provide an easily-navigated, interactive medium in a familiar environment that illustrates many of the 4PL data analysis concepts and recommendations in the new suite of bioassay chapters, particularly <1034> Analysis of Biological Assays. It is also intended as a learning environment for scientists or statisticians who need to become more familiar with 4PL bioassay data analysis. Access simulator now.

• <1> INJECTIONS
• <85> BACTERIAL ENDOTOXINS TEST
• <88> BIOLOGICAL REACTIVITY TESTS, IN VIVO
• <467> RESIDUAL SOLVENTS
• <659> PACKAGING AND STORAGE REQUIREMENTS
• <1027> FLOW CYTOMETRY
• <1047> GENE THERAPY PRODUCTS
• <1084> GLYCOPROTEIN AND GLYCAN ANALYSIS-GENERAL CONSIDERATIONS
• <1113> MICROBIAL CHARACTERIZATION, IDENTIFICATION, AND STRAIN TYPING (New)
• <1116> MICROBIOLOGICAL CONTROL AND MONITORING OF ASEPTIC PROCESSING ENVIRONMENTS
• <1128> NUCLEIC ACID-BASED TECHNIQUES—MICROARRAY
• <1124> TRANSFER OF ANALYTICAL PROCEDURES
• <1180> HUMAN PLASMA
• <1226> VERIFICATION OF COMPENDIAL PROCEDURES 

• Calcitonin Salmon (20 mg), Item Number 1086210
• Calcitonin Salmon Related Compound A (20 mg) (N-acetyl-Cys(1)-calcitonin salmon), Item Number 1086210
• Calcitonin Salmon Related Compound B (0.34 mg) (calcitonin salmon-glycine), Item Number 1086221
• rGlucagon (2.94 mg) (recombinant Glucagon (Human)), Item Number 1294036
• Enoxaparin Sodium for Bioassays, Item Number 1235831
• rAlbumin Human (4.92 mg) (Recombinant Human Albumin), Item Number 1012595

• KDN (100 mg) (3-Deoxy-D-glycero-D-galacto-2-nonulosonic acid), Item Number 354852
• N-Glycolylneuraminic Acid (200 mg), Item Number 1294284
• N-Acetylneuraminic Acid (200 mg), Item Number 1612619

• UFH Molecule Weight Calibrant
• Fetal Bovine Serum
• rHuman Interleukin 4
• Filgrastim
• Octreotide Acetate
• Octreotide Acetate (non-cyclic) System Suitability Marker
• USP Oligosaccharide System Suitability Standards
• Protein A

• Biologics, Biotechnology Therapies Are Focus of USP Symposium on Drug Quality Standards (06–Sept–2011)
• US Pharmacopeia develops and improves its class approach for ensuring quality biopharmaceuticals(01–Mar–2011)
• USP is advancing efforts to develop guidance for evaluating bioassays. (01–Jul–2010)

• December 2011
• August 2011
• March 2011
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