-

Thermo Fisher Scientific Introduces QualTrak Biopharma qPCR Solutions to Streamline Biologics Development and Compliance

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

CARLSBAD, Calif.--(BUSINESS WIRE)--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.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Contacts

Media Contact Information:

Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com

Jen Heady
Phone: 413-237-5141
Email: jheady@greenough.biz

Thermo Fisher


Release Summary
Thermo Fisher Scientific launches QualTrak suite of qPCR biopharma offerings to help accelerate drug development .
Release Versions

Contacts

Media Contact Information:

Mauricio Minotta
Phone: 760-805-5266
Email: mauricio.minotta@thermofisher.com

Jen Heady
Phone: 413-237-5141
Email: jheady@greenough.biz

More News From Thermo Fisher

Thermo Fisher Scientific Launches CTS Detachable Dynabeads CD4 and CTS Detachable Dynabeads CD8 to Enhance Cell Therapy Development and Production

WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today unveiled the Gibco™ CTS™ Detachable Dynabeads™ CD4 and CTS Detachable Dynabeads CD8 (CTS Detachable Dynabeads)*. These latest products expand on Thermo Fisher’s CTS Detachable Dynabeads platform, which represents a new generation of cell therapy isolation and/or activation products that prioritize cell quality while also creating greater workflow control. Ultimately, these products can hel...

Thermo Fisher Scientific Opens Its First Electron Microscopy Demo Center in Taiwan

HILLSBORO, Ore.--(BUSINESS WIRE)--To support next-generation semiconductor and materials innovation, Thermo Fisher Scientific today announced the opening of its first electron microscopy demo center in Taiwan. This state-of-the-art facility, called a NanoPort, is strategically located in the region’s semiconductor manufacturing hub and designed to meet the area’s growing need for advanced analytical instruments and expertise. The new center is now one of six Thermo Fisher NanoPort facilities wo...

Thermo Fisher Scientific Opens New GMP-certified Ultra-cold Facility in the EU to Accelerate Advanced Therapies Development

BLEISWIJK, Netherlands--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, has opened a new clinical and commercial ultra-cold facility in the EU, expanding its clinical trial network in Europe to help accelerate the development of advanced therapies. The new current good manufacturing practice (cGMP) facility in Bleiswijk, Netherlands provides pharma and biopharma customers tailored, end-to-end support throughout the clinical supply chain for high-value therap...
Back to Newsroom