Quality Control Procedures
Document# Title
QCP-001 Determination of pH
QCP-002 Physical Appearance of Bulk Drug Substance and Final Drug Product
QCP-003 Determination of Cell Concentration and/or Cell Viability Using a Hemacytometer
QCP-006 Restriction Enzyme Digest and Agarose Gel Analysis of DNA Fragments
QCP-007 Analysis of Bacterial Culture to Determine Antibiotic Resistance
QCP-008 Detection of Bioburden Contamination Based on USP <71> Sterility Testing
QCP-009 Protein Quantification Via BCA
QCP-010 Immunoenzymetric Assay for the Quantification of E. coli Host Cell Proteins
QCP-012 Spectrophotometric Assay for Determining DNA, RNA, and Viral Particle Concentration
QCP-013 LAL Test for Bacterial Endotoxin via KineticTurbidimetric Assay
QCP-017 Microscopic Characterization of Bacteria
QCP-020 Identity and Quantitation of Supercoiled DNA by Agarase Gel Analysis
QCP-021 Optical Density of a Cell Suspension
QCP-024 HPLC Method for the Quantitation of Plasmid DNA and RNA
QCP-025 Growth Promotion of Media Used for Sterility Testing
QCP-026 Preparation of scDNA HPLC Standards
QCP-028 Preparation and Shipment of Materials for Testing by Contract Facilities
QCP-029 Determination of Specific Gravity
QCP-030 Inspection of Sterile Product Vials, Pre- and Post-filled
QCP-031 Use and Interpretation of Biological Indicators Used to Asses Efficacy of Steam Sterilization
QCP-032 Determination of Filter Integrity
QCP-034 Preparation of Microbial Glycerol Stocks
QCP-035 SDS-PAGE Characterization of Proteins
QCP-036 Western Blot Characterization
QCP-037 Characterization of Proteins Via Isoelectric Focusing
QCP-040 HPLC Method for the Quanitation of Adenovirus Particles
QCP-041 dsDNA Quantitation Using PicoGreen
QCP-045 HPLC Method for Estimating Numbers of Adenovirus in Crude Samples
QCP-046 ELISA Assay for Benzonase Endonuclease
QCP-048 HPLC Method for Quantifying and Determination per cent Purity of Rnase 1
QCP-049 RiboGreen Residual RNA Quantitation Assay
QCP-050 Lentiviral RNA LTR TaqMan RT-PCR Assay
QCP-051 Viable Particulates Environmental Monitoring
QCP-052 Environmental Monitoring of Surfaces
QCP-053 Dynamic Environmental Monitoring
QCP-054 Non-Viable Particulates Environmental Monitoring
QCP-056 Bacterial Culture Growth and Harvesting to Yield Protein
QCP-057 Cell Counts of Bacterial Cultures
QCP-058 Spectroscopic Assay for Determining Protein Concentration
QCP-059 Identification of Listeria Species or L. monocytogenes via Morphological Analysis
QCP-060 Listeria Monoculture Assay
QCP-063 Analysis of Bacterial Culture to Determine Antibiotic Sensitivity
QCP-064 6-Well Plaque Assay for Adenovirus
QCP-065 Adenovirus Rapid Titer Assay
QCP-066 Immunoenzymetric Assay for the Quantification of HEK 293 Host Cell Proteins
QCP-068 Ammonium Identiy Test
QCP-069 Calcium Identity Test
QCP-070 Carbonate/Bicarbonate Identity Test
QCP-071 Chloride Identity Test for Non-amine Hydrochlorides
QCP-072 Phosphate Identity Test
QCP-073 Potassium Identity Test
QCP-074 Hepatitis E Virus TaqMan RT-PCR Assay
QCP-075 Kinetic Assay for Determining Specific Activity of a Protein via Absorbance and Conversion from Enzymatic
QCP-081 Modified Bioburden Testing
QCP-083 TOC Analysis of Swab and Rinse Samples for Cleaning Validation/Verification
QCP-084 Immunoenzymetric Assay for the Quantificatin of Human Fibroblast Growth Factor Basic (FGF Basic = FGF
QCP-085 Preparation of Blood and Body Fluids for Sterility Testing
QCP-086 HPLC Method for Determining FGF2 Purity
QCP-088 Protein Concentration Determined by Bradford Assay Using IgG Standard
QCP-089 MTT Assay to Determine the EC50 of FGF-2
QCP-090 HPLC Method for Quantifying FGF2
QCP-091 Prep/Shipment/Results Interpretation of G-Banding Analysis for Stem Cells
QCP-097 HIV p24 Assay for Detecting Lentivirus Associated p24 and free p24
QCP-098 Prep/Shipment/Results Interpretation of hESC Analysis for Cell Culture Reagents
QCP-103 Seeding Efficiency for Adherent Cell Lines
QCP-105 Initiation and Culturing of hESC fo rth ePurpose of Final Product testing
QCP-108 Procedure for Flow Cytometry Analysis of Mesenchymal Stem Cells
QCP-109 Protein Qualification via BCA Assay Method
QCP-111 EV71 TCID50 Titering assay
QCP-113 Modified Bioburden Testing Using Membrane Filtration
QCP-116 ELISA Assay to Determine Residual FBS (BSA)
QCP-117 Procedure for Immunopotency Assay of Mesenchymal Stem Cells
QCP-118 Procedure for Immunopotency Analysis of Mesenchymal Stem Cells
QCP-120 Procedure for Leukopak Preparation of PBMCs for use in Potency Assay of MSC
QCP-122 Procedure for Growing and Expanding Mesenchymal Stem Cells
QCP-123 Vero Cell Growth and Expansion Procedure