Molecular
Biology Services
The analytical method Nucleic Acid Techniques (NAT) is widely used
in the quality control of biological manufacturing and lot
release of drug product. Vitrology provides a wide range of Quantitative
Polymerase Chain Reaction (qPCR) testing services to meet your preclinical
and clinical requirements.
Vitrology’s
molecular biology experts were first to publish the
NAT validation and assay control system currently recommended in
the European Pharmacopoeia 2.6.21. (Nucleic acid amplification techniques)
and 2.6.7. (Mycoplasmas: Validation of NAT for the detection of
mycoplasma: guidelines). (Lovatt et al. 2002)
Each
Scientist has at least 10 years experience in setting the
current biopharmaceutical industry standards for the development
and validation of Platinum-grade high-throughput real-time quantitative
PCR (qPCR) assays . Vitrology provides US and PH.Eur. regulatory
compliant qPCR assays for a wide variety of applications. All qPCR
assays are performed on our ABI 7900HT using TaqMan technology,
in accordance to criteria required for maintaining 21CFR part 11
compliance. Our interactive IT system coupled with our ability to
condense our workflow onto high-density 384-well qPCR applications
provides enhanced assay turnaround times for our clients. With our extensive
knowledge of assay development and sample processing,
Vitrology is aiming to be the leading provider of services to the
biopharmaceutical industry.
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