![Service Offering
In vitro testing for adventitious virus is used/required at a
number of different points in the production of products
derived from growth in mammalian cell culture. Typically,
Master and Working cell banks, End of Production cell
banks, and bulk harvests are tested and tests are designed
to detect a broad spectrum of potential contaminants as
well as species specific and retroviruses which may require
more specific tests.
Benefits of BioOutsource in vitro testing
service include:
• Fully GMP compliant facility and services (inspected by
the MHRA in March 2008).
• Compliance with the following regulatory guidance:
– European Pharmacopeia Guidelines 2.6.16:
Tests for Extraneous Agents in Viral Vaccines for • Primary cell lines also available on request for
Human Use specialist requirements
– Q5A (Viral Safety Evaluation of Biotechnology • Qualification of Limit of Detection of specific viruses
Products Derived from Cell Lines of Human or dependant on sample type; typical sample detection
Animal Origin – 1997) already achieved is between 10-1000 TCID50
– Points to Consider in the characterization of cell
lines used to produce biologicals” (FDA, CBER,
1993
Sample Requirements
The client will provide sufficient sample for analysis.
• Validated and characterised detection cell banks
including – the human diploid cell line MRC-5, the Using the BioWeb, online sample submission eliminates
Human cells line HeLa, the primate cell bank Vero, the potential for errors with sample receipt.
Chinese Hamster Ovary cells, Bovine cell line [Madin Product samples: Raw materials of animal origin, bulk
Darby Bovine Kidney], Porcine cell line [Primary Porcine harvest and in-process samples.
Kidney cell line], Mouse cells [SC-1], the canine cell
line [Madin Darby Canine Kidney] Control samples: Qualification samples typical of the
testing matrix.
• Validated Haemagglutination and Heamadsorbtion
end points
Reporting of Results
• Validated and characterised control virus banks
including – Adenovirus, Herpes Simplex type 1 virus, All reports and laboratory data are available on line using our
parainfluenza virus, Influenza virus and, Reovirus Type BioWeb web based interactive tool following completion of
the assay. The Final Report can be custom designed to the
• Extensive experience of handling a variety of Test sponsor’s requirement using any format.
Materials requiring appropriate sample preparation
High Speed turnaround of studies – Sample receipt to final
• Production, assessment and qualification of neutralising certificate of analysis within one week of study completion.
antiserum available for live virus vaccine testing
BioOutsource Ltd • Units 3/4 Technology Terrace • Todd Campus • West of Scotland Science Park • Glasgow • G20 0XA
tel: +44 (0)141 946 4222 • email: info@biooutsource.com • web: www.biooutsource.com](https://image.slidesharecdn.com/biooutsourcevirustesting-110902112243-phpapp01/85/Bio-outsource-virus_testing-2-320.jpg)
Bio outsource virus_testing
- 1. BioOutsource – in vitro Virus Safety Testing The potential for virus contamination in biologic products and vaccines produced using mammalian systems is one of the major concerns of any production process. Accidental (adventitious) contamination can be introduced at any step through a variety of means including operator error, GMP breakdown or through the use of contaminated reagents such as starting raw materials of animal origin. BioOutsource has developed and validated a comprehensive range of in vitro virus detection assays that can be to test for the presence of viruses in a variety of different product types. Currently, BioOutsource provides GMP testing services for batch release in the USA and Europe. Expertise, Quality, Communication BioOutsource’s service in adventitious virus testing is BioOutsource extensive validation package provides a based upon a strong understanding of virology and many detailed report on the validation of the assays to ICH years of experience in virus safety testing for a wide guidelines and is available to all clients to use as part range of products from monoclonal antibodies to live of their regulatory submission; facilitating regulatory virus vaccines and gene therapies. approval for the GMP compliant batch release of their product. BioOutsource’s facilities and services have been inspected by the UK MHRA and are GMP compliant. All BioOutsource’s clients benefit from the industry- Virus safety testing is carried out in compliance with GMP leading BioWeb technology which has been developed and with the following regulatory guidance: to allow our clients unprecedented access to study documentation and data. Through the BioWeb our clients • European Pharmacopeia Guidelines 2.6.16: Tests for have 24/7, on-line access to their studies which allows Extraneous Agents in Viral Vaccines for Human Use early access to results, informed decision-making and • Q5A (Viral Safety Evaluation of Biotechnology effective project management. Products Derived from Cell Lines of Human or Animal Origin – 1997) • “Points to Consider in the characterization of cell lines used to produce biologicals” (FDA, CBER, 1993)
- 2. Service Offering In vitro testing for adventitious virus is used/required at a number of different points in the production of products derived from growth in mammalian cell culture. Typically, Master and Working cell banks, End of Production cell banks, and bulk harvests are tested and tests are designed to detect a broad spectrum of potential contaminants as well as species specific and retroviruses which may require more specific tests. Benefits of BioOutsource in vitro testing service include: • Fully GMP compliant facility and services (inspected by the MHRA in March 2008). • Compliance with the following regulatory guidance: – European Pharmacopeia Guidelines 2.6.16: Tests for Extraneous Agents in Viral Vaccines for • Primary cell lines also available on request for Human Use specialist requirements – Q5A (Viral Safety Evaluation of Biotechnology • Qualification of Limit of Detection of specific viruses Products Derived from Cell Lines of Human or dependant on sample type; typical sample detection Animal Origin – 1997) already achieved is between 10-1000 TCID50 – Points to Consider in the characterization of cell lines used to produce biologicals” (FDA, CBER, 1993 Sample Requirements The client will provide sufficient sample for analysis. • Validated and characterised detection cell banks including – the human diploid cell line MRC-5, the Using the BioWeb, online sample submission eliminates Human cells line HeLa, the primate cell bank Vero, the potential for errors with sample receipt. Chinese Hamster Ovary cells, Bovine cell line [Madin Product samples: Raw materials of animal origin, bulk Darby Bovine Kidney], Porcine cell line [Primary Porcine harvest and in-process samples. Kidney cell line], Mouse cells [SC-1], the canine cell line [Madin Darby Canine Kidney] Control samples: Qualification samples typical of the testing matrix. • Validated Haemagglutination and Heamadsorbtion end points Reporting of Results • Validated and characterised control virus banks including – Adenovirus, Herpes Simplex type 1 virus, All reports and laboratory data are available on line using our parainfluenza virus, Influenza virus and, Reovirus Type BioWeb web based interactive tool following completion of the assay. The Final Report can be custom designed to the • Extensive experience of handling a variety of Test sponsor’s requirement using any format. Materials requiring appropriate sample preparation High Speed turnaround of studies – Sample receipt to final • Production, assessment and qualification of neutralising certificate of analysis within one week of study completion. antiserum available for live virus vaccine testing BioOutsource Ltd • Units 3/4 Technology Terrace • Todd Campus • West of Scotland Science Park • Glasgow • G20 0XA tel: +44 (0)141 946 4222 • email: info@biooutsource.com • web: www.biooutsource.com