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General Biopharmaceutical Standards General Pharmaceutical Standards Lyophilization Process Understanding and PAT System Management, Implementation and Practice Terminology

General Biopharmaceutical Standards

E2097-00(2014) Standard Guide for Determining the Impact of Extractables from Non-Metallic Materials on the Safety of Biotechnology Products (Withdrawn 2022)

E1286-00(2006) Standard Guide for Identification of Herpes Simplex Virus or Its DNA (Withdrawn 2014)

E1532-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Use of Bisbenzamide DNA-Binding Fluorochrome (Withdrawn 2014)

E1536-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Bovine Serum by Large Volume Method (Withdrawn 2014)

E1873-06 Standard Guide for Detection of Nucleic Acid Sequences by the Polymerase Chain Reaction Technique (Withdrawn 2014)

E1759-95(2003) Standard Test Method for Isoaspartic Acid in Proteins: Method for the Determination of Asparagine Deamidation Products (Withdrawn 2003)

E1470-92(2006) Standard Test Method for Characterization of Proteins by Electrophoretic Mobility (Withdrawn 2014)

E2048-99(2006) Standard Guide for Detection of Nucleic Acids of the Mycobacterium Tuberculosis Complex and Other Pathogenic Mycobacteria by the Polymerase Chain Reaction Technique (Withdrawn 2014)

E1298-06 Standard Guide for Determination of Purity, Impurities, and Contaminants in Biological Drug Products (Withdrawn 2014)

E1531-00(2006) Standard Practice for Detection of Mycoplasma Contamination of Cell Cultures by Growth on Agarose Medium (Withdrawn 2014)

E1285-06 Standard Guide for Identification of Bacteriophage Lambda (λ) or Its DNA (Withdrawn 2014)

E1533-00(2006) Standard Practice for Indirect Detection of Mycoplasma in Cell Culture by 4`-6-Diamidino-2-2 Phenylindole (DAPI) Staining (Withdrawn 2014)

E1493-06 Standard Guide for Identification of Bacteriophage M13 or Its DNA (Withdrawn 2014)

General Pharmaceutical Standards

E3060-23 Standard Guide for Subvisible Particle Measurement in Biopharmaceutical Manufacturing Using Dynamic (Flow) Imaging Microscopy

Lyophilization

E3250-21 Standard Practice for Product Temperature and Equipment Pressure Instrumentation in Pharmaceutical Freeze Drying

Process Understanding and PAT System Management, Implementation and Practice

E2474-14 Standard Practice for Pharmaceutical Process Design Utilizing Process Analytical Technology (Withdrawn 2020)

Terminology

E2363-23 Standard Terminology Relating to Manufacturing of Pharmaceutical and Biopharmaceutical Products in the Pharmaceutical and Biopharmaceutical Industry