Vitrology News Archive 2009

Vitrology Secures Investment to Support Enhanced Viral Safety Testing of Human Medicines

September 2009

Vitrology have secured additional investment and funding of approximately £500,000 for the support of additional service development, including the validation of enhanced nucleic acid detection systems for the viral safety testing of biopharmaceuticals, vaccines and genetic therapeutics. The company has already validated over one hundred molecular-based viral detection systems for a wide range of virus species of concern and this additional funding will allow enhancement of highly sensitive fluorescence-based detection systems for ensuring the safety of human medicines. This array of viral detection assays are commonly used in the lot release of vaccines and biopharmaceuticals and Vitrology continues to develop and enhance these services for our customers. In addition, our continuous and extensive partnership with Moredun Scientific at the Pentlands Science Park, brings the complementary skills for our clients, offering a complete testing solution for biopharmaceutical and vaccine manufacturing.

Vitrology Develops Highly Sensitive QPCR Test for the Detection of Vesivirus 2117 in Biopharmaceuticals

Recent press releases from a major biopharmaceutical company have reported a viral contamination in a bioproduction process. The virus was identified as a Vesivirus (Strain 2117). Vesivirus is a 32-40 nm non-enveloped RNA virus in the Calicivirus family (picture shown on the left). Virus contaminations such as this can interrupt production at manufacturing plants, and may result in extremely expensive processes to sanitize the facility. The Vesivirus impairs the viability of cells used in the biopharmaceutical manufacturing process, but is not known to cause infection in humans. The impact of this event to the biopharmaceutical industry is still unknown, and future regulatory requirements in response to this event will require the evaluation of mammalian-derived bio therapeutic products, and the raw materials for the detection of Vesivirus. To assist biotech companies in their evaluation, Vitrology have responded rapidly and developed a sensitive quantitative PCR screening test for the detection of Vesivirus 2117 RNA in the manufacturing process. The test may also be used to evaluate the capability of biological drug purification processes to remove or inactivate this potential viral contaminant.

Human “Swine“ flu and vaccine Testing

1st May 2009

As with other biologics, adventitious viral agents pose a significant risk to any cell culture influenza vaccine production process, as will be the case with Swine flu vaccine.

The selection of viruses to be tested depends upon the origin and history of the production cell line, virus vaccine seed and raw material used in the bioproduction process. The testing for the presence of human viruses is required when the vaccine seed virus is of human respiratory origin. Avian retroviruses are also of concern if the virus vaccine seed has had historical culture within eggs.

The regulatory acceptance of highly sensitive virus detection methods has depended on PCR assays that are validated to ICH guidelines. Assay validation parameters such as detection limit (DL), specificity, quantitative range, 95% cut-off and quantitation limit (QL) are described in ICH Topics Q2A & B (Validation of analytical methods) and European Pharmacopeia (Nucleic acid amplification techniques).

Vitrology offers a comprehensive array of adventitious agent testing services to test influenza seed stocks and viral harvests including:

• QPCR packages for bacterial, human, and avian viruses of concern, to ICHQ2 and Phar. Eur. 2.6.21 compliance
• QPCR packages for a range of swine and bovine viruses of concern, to ICHQ2 and Phar. Eur. 2.6.21 compliance
• Q & F-PERT assays for Retrovirus detection
• Sterility, Mycoplasma and In vivo adventitious agent assays
• Electron Microscopy and In vitro adventitious agent assays

For more details please contact us.   Further video press and video coverage can be found at the following links:

Press release:

http://news.bbc.co.uk/1/hi/scotland/glasgow_and_west/8025640.stm

Video Link :

http://news.stv.tv/home/91746-glasgow-scientists-work-on-swine-flu-vaccination