Table 1 Specifications for the GAP MCB
Assay | Specifications (acceptance criteria) | Test methods | Performed by |
|---|---|---|---|
Red cell pellet | > 50 μL of RBC pellet is required after thawing the 3D7 KAHRP-KO GAP MCB and centrifuging the RBC suspension | Measured using a calibrated pipette | QIMR-B |
Identification | Absence of kahrp gene | P. falciparum 3D7 KAHRP-KO GAP Verification | QIMR-B |
Percent parasitaemia | > 3% parasitized RBC ≥ 80% ring stage parasite | Malaria thin film smears | QIMR-B |
Percent viable (active cell frequency) parasites | ≥ 25% viable | Limiting dilution assay | QIMR-B |
Sterility | No growth | Microbial Contamination and Sterility Testing (SOP QC-11) British Pharmacopoeia (BP) 2015, Appendix XVI A: test for sterility | Q-Gen |
Endotoxin Testing | < 5 EU/mL | Lonza’s Limulus Amebocyte Lysate (LAL) PYROGENT™ Ultra Assay | Q-Gen |
Mycoplasma | No mycoplasma detected | Test for the detection of mycoplasma including qualification of the test article in accordance with European pharmacopeia, section 2.6.7 mycoplasmas | BioReliance |
Spiroplasma culture | Not detected | Test for the detection of agar cultivable Spiroplasma including qualification of test article in accordance with US Pharmacopeia < 63 > mycoplasma/spiroplasma testing | BioReliance |
HIV 1 and 2 | Not detected | Real time PCR assay for the detection of HIV I and HIV II in biological samples | BioReliance |
HTLV I and II | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of HTLV | BioReliance |
EBV | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
CMV | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
Hepatitis C Virus | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
Hepatitis B Virus | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
Human Parvovirus (B19) | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
West Nile virus (WNV) | Not detected | Real time PCR for the detection of WNV in biological samples | BioReliance |
Adeno-associated virus (AAV) | Not detected | Pinnacle Q-PCRâ„¢ assay for multiple serotypes of adeno-associated viruses (AAV) pathogen detection | BioReliance |
Human Herpes virus type 7 | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
Human Herpes virus type 6 | Not detected | Pinnacle Q-PCRâ„¢ assay for the detection of PCR for viral genome | BioReliance |
Retroviruses | Report Result | Evaluation of reverse transcriptase activity by ultracentrifugation and quantitative fluorescent product enhanced reverse transcriptase (QPERT) assay | BioReliance |
Quantitative transmission electron microscopy of sections for the detection of viruses, fungi, yeasts, bacteria and mycoplasmas (200 cell profiles) | No extraneous agents observed in the 200 cell profiles examined | Quantitative transmission electron microscopy of sections for detection of viruses, fungi, yeasts, bacteria and mycoplasmas (200 cell profiles) | BioReliance |
Presence of viral contaminants | Not detected | In vitro assay for the detection of viral contaminants using 3 detector cell lines | BioReliance |
Presence of inapparent viruses | Not detected | Test for the presence of inapparent viruses using suckling mice, adult mice, guinea pigs and embryonated eggs in accordance with FDA CBER guidance | BioReliance |