May 11, 2022 -- Thermo Fisher Scientific has launched a series of QualTrak quantitative polymerase chain reaction (qPCR) biopharma solutions to enhance the drug development process for biologics. The qPCR offerings include QuantStudio 6 and 7 Pro real-time PCR systems and TaqMan and TaqPath master mixes and assays. These innovations support biopharma companies developing these novel therapeutics over the course of the lifespan of the biologics.
This QualTrak suite contains efficient compliance documentation processes to ensure regulatory compliance during all stages of the manufacturing process. The QualTrak software also readily supports drug filings. The TaqPath master mixes and assays are manufactured according to current good manufacturing practice (cGMP) requirements in independent service organization (ISO) 13485-certified facilities, with high consistency between lots. Additionally, the QualTrak package allows customers to sign up for notification of any product changes without the need for a supply agreement.
To complement the QualTrak package, Thermo Fisher has also released a new QualTrak app, for integrated and streamlined access to all qPCR products used in biopharma. This interactive portal enables quick identification of PCR steps depending on the therapeutic modality and development phase, applying to the development of monoclonal antibodies, vaccines, and cell and gene therapies.
Furthermore, Thermo Fisher has launched its Applied Biosystems TaqPath BactorPure master mix for low-level microbial detection to provide products free of microbial contaminants. The master mix can detect as little as one copy of DNA from bacterial, fungal, viral, and mammalian sources with significant consistency and sensitivity.
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