Virology Testing

Bovine Viruses

Study Design

In vitro detection of BVDV by cytopathic effect on indicator cell line susceptible to BVDV infection or by BVDV specific antibodies in IFA (immunofluorescence assay)
Sub passages on fresh indicator cells
Qualitative assay

Assay Duration: 21 days
Sample Requirement: Dependent on customer supplied product

Regulatory Compliance

9 CFR
EMEA/CVMP/743/00
European Pharmacopoeia

Custom Assays

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize bovine virus testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

Technical Library

Data Sheet

Adventitious Viruses

Study Design

In vitro detection of virus presence by cytopathic effects and/or adsorption of red blood cells to cultured cells, inoculated with test article
Sub passages on fresh indicator cells
Qualitative assay

Assay Duration: Cultivation period of 14 (EP) or 28 days (USP)
Sample Requirement: Dependent on customer supplied product

Regulatory Compliance

European Pharmacopoeia
ICH Q5A/Q5B
Center for Biologicals Evaluation and Research, FDA, Points to Consider in the Characterization of Cell Lines Used To Produce Biologicals (1993)

Custom Assays

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize adventitious virus testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

Technical Library

Data Sheet

Replication Competent Retroviruses

Study Design

Infectivity Assays

Inoculation (for bulk product) or cocultivation (for cell suspensions) with Mus Dunni cells or 293 cells and subsequent evaluation in the PG-4 S+L- assay

Supernatant Testing Assays

Supernatant assays include culture of supernatant on a permissive cell line [Mus dunni} for a minimum of 5 passages in order to amplify any potential RCR present. The amplified material is then detected in an appropriate indicator cell assay [e.g., PG-4 S+L- (1)]. All assays include relevant positive and negative controls to assess specificity, sensitivity and reproducibility of the detection method. Each lot of retroviral vector supernatant is tested for inhibitory effects on detection of RCR by using positive control samples that are diluted in vector supernatant.

Cell Testing Assays

Cell testing assays include 1% of the total cells or 108 (whichever is less) pooled vector-producing cells by coculture with a permissive cell line will remain in place. Co-culture assays should include culture with a permissive cell line [ex. Mus dunni] for a minimum of five passages in order to amplify any potential RCR present. The amplified material may then be detected in an appropriate indicator cell assay [e.g., PG-4 S+L- (1)]. All assays include relevant positive and negative controls to assess specificity, sensitivity and reproducibility of the detection method.

Assay Duration: 1 week without coculture; 5 weeks with co-culture
Sample Requirement: Dependent on customer supplied product

Regulatory Compliance

FDA/CBER Guidance for Human Somatic Cell Therapy and Gene Therapy (1998)
FDA/CBER Supplemental Guidance on RCR testing (2000)
EMEA/CPMP/BWP/3088

Custom Assays

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize replication competent retroviruses testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

Technical Library

Data Sheet

Ecotropic/Xenotropic Murine Leukemia Viruses

Study Design

Detection of Ecotropic Murine Leukemia Virus in the XC-Plaque Assay

Culture method for the detection of infectious Ecotropic Murine Leukemia Virus. Test can be performed either directly or after amplification on sensitive mouse cells.

A double phase assay:

First culture of specific cells that permit virus replication without cytopathic effect (CPE)
SC I cells are inactivated by UV irradiation
Rat cells that harbor a defective retrovirus are the detection system
Ecotropic virus sequences restore the rat virus to competence

Detection of Xenotropic Murine Leukemia Virus in the S+L- assay

Culture method for the detection of infectious retrovirus virus using either Mink S+L- assay of PG-4 S+L- assay. Tests can be performed either directly (quantitative) or after amplification on Mink Lung cells.
Assay cell line harbors a defective sarcoma virus that is restored to competence by co-infection with xenotropic virus
Results in uncontrolled cell proliferation

Assay Duration: 1 week without coculture; 5 weeks with co-culture
Sample Requirement: Dependent on customer supplied product

Regulatory Compliance

European Pharmacopoeia
ICH Q5A/Q5B
Center for Biologicals Evaluation and Research, FDA, Points to Consider in the Characterization of Cell Lines Used To Produce Biologicals (1993)

Custom Assays

We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize murine leukemia virus testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.

Technical Library

Data Sheet

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