QualTrak Biopharma qPCR Solutions to Streamline Biologics Development

Offerings include TaqPath BactoPure microbial detection master mix to help ensure drug products are contaminant free

CARLSBAD, CA — Thermo Fisher Scientific today launched a new collection of qPCR biopharma offerings to help accelerate drug development to meet a growing demand for novel biologics. The QualTrak comprehensive suite of qPCR tools is comprised of a premium selection of trusted Applied Biosystems solutions, including QuantStudio 6 and 7 Pro Real-Time PCR Systems* and TaqMan and TaqPath master mixes and assays, to consistently and accurately support the biopharma industry from discovery to post-approval manufacturing.

"PCR-based technologies play an integral role across all phases of drug development, and biopharmaceutical developers and manufacturers need reliable tools to help them avoid wasting precious time and resources repeating and revalidating steps," said Santhosh Nair, vice president and general manager of qPCR at Thermo Fisher Scientific. "By tailoring our qPCR and dPCR offerings to the unique needs of biologic developers and CDMOs, we are helping to fill gaps and address critical consistency and compliance pain points in the development process."

QualTrak solutions come with readily available compliance documentation to reduce the time required to comply with internal quality systems and regulatory requirements. The carefully curated selection of high-quality qPCR master mixes, assays, instruments, and software are backed by world-class service and support to help simplify drug filings. To support post-discovery steps such as manufacturing QC and biodistribution where reliable results and regulatory compliance are critical, QualTrak TaqPath master mixes and assays are manufactured at an ISO 13485-certified, U.S. Food and Drug Administration (FDA) registered facility that adheres to cGMP manufacturing requirements and demonstrates exceptional lot-to-lot consistency.

With its vertically integrated supply chain and extensive logistics network, Thermo Fisher is positioned to support growing global demand for biopharma-specific qPCR solutions. In addition, for the first time customers can easily and quickly sign up to be notified of product changes without entering into a supply agreement.

QualTrak Portal

To complement the new offerings, Thermo Fisher is introducing a new downloadable app highlighting qPCR workflows and products for specific use cases across monoclonal antibodies (mAbs), vaccines, and cell and gene therapies development pipelines. Until now, scientists had to navigate multiple websites to find biopharma-specific qPCR products for their biologics development. With the launch of the first-of-its-kind QualTrak app, customers have a central location to find the products and services they need. The new, interactive portal can quickly identify suggested PCR steps based on therapeutic modality and development phase, expediting product selection.

Applied Biosystems TaqPath BactoPure Microbial Detection Master Mix**

To support biologic manufacturers' stringent quality control testing requirements, Thermo Fisher is also launching the Applied Biosystems TaqPath BactoPure master mix for consistent low-level microbial detection. This new qPCR master mix can detect as low as one copy of DNA per microliter from bacterial, viral, fungal, and mammalian sources, helping to ensure contamination-free drug products and accurate titers. Manufactured at an ISO 13485-certified and FDA-registered cGMP facility, BactoPure delivers superior lot-to-lot consistency and sensitivity, even in the presence of inhibitors.

The exceptional performance of the TaqPath BactoPure Master Mix also makes it a valuable tool for assay developers in infectious disease testing labs to identify bacterial, viral, fungal DNA, and antibiotic resistance markers in clinical research samples.

For more information about QualTrak qPCR biopharma workflows, please visit thermofisher.com/qpcr/biopharma

*For research use only. Not for use in diagnostic procedures.

**For laboratory use.