Manufacturing site change

In April 2014, the manufacturing of TaqMan® Universal Master Mix was transferred from a Roche Molecular Systems manufacturing site to a Thermo Fisher Scientific manufacturing site.

This was a manufacturing location change only. The formulation of the components, such as the polymerase, has not changed.

The formulation for TaqMan® Universal Master Mix, including its components, is proprietary to Life Technologies, now part of Thermo Fisher Scientific. Previously, Roche Molecular Systems was contracted to manufacture TaqMan® Universal Master Mix, but this master mix formulation is now manufactured exclusively by Thermo Fisher Scientific.

Ensuring continuity to our customers

In recognition of the importance of these products to our customers’ protocols, we worked diligently to help ensure that the manufacturing change resulted in no changes to the product formulation or performance. Extensive testing was performed after the manufacturing transition, and these products were released to customers only after these studies demonstrated no discernible differences in fit, form, or function. These equivalency reports are available on the product web pages.

Changes to be aware of:

While the product, including part numbers, remains the same, the following describes what has been modified and improved as a result of the transition.

Packaging and shipping changes

  • The box and tube labels, lot number format, and product insert have been revised to reflect the transition.
  • The shipping conditions have been changed from dry ice to frozen gel packs to align with other master mix products.

Improvements

  • Additional QC testing
    Additional analytical and functional QC tests have been added to the manufacturing process. The new product Certificate of Analysis (CoA) includes these additional analyses, along with the original QC specification from Roche Molecular Systems.
  • Longer shelf life
    Shelf life has been extended from 1 year to 1.5 years.
  • Support for your cross-validation studies
    Many customers have already successfully cross-validated our change in manufacturing. To support laboratories through the transition and help ensure smooth and seamless conversion, customers can request and purchase lots of TaqMan® Universal Master Mix manufactured at a Roche Molecular Systems site for side-by-side comparison with TaqMan® Universal Master Mix made at a Thermo Fisher manufacturing site. The material manufactured by Roche Molecular Systems is in limited supply, and this offer will continue only while supplies last.

For customers located in the US and Canada, please call 1-800-955-6288, extension 41315, or email SpecialLotRequest@lifetech.com and specify “Roche-made lot” to purchase the Roche-made master mix. For other customers, please contact your local customer service representative.

Transition of inventory

We are in the process of completely transitioning our existing global inventory of TaqMan® Universal Master Mix from one produced by Roche Molecular Systems to one made at a Thermo Fisher manufacturing site. We estimate that this process will be complete in the next few months. During this period some customers may receive TaqMan® Universal Master Mix that was manufactured by Roche Molecular Systems. The formulation and performance of TaqMan® Universal Master Mix has not changed with the transition of manufacturing to the Thermo Fisher manufacturing site. This is a manufacturing location change only. The formulation of the components has not changed.

To request an exchange for TaqMan® Universal Master Mix made at a Thermo Fisher Scientific manufacturing site: For customers located in the US and Canada, please call 1-800-955-6288, extension 41315, or email SpecialLotRequest@lifetech.com and specify “Thermo Fisher Scientific-made lot” For other customers, please contact your local customer service representative.

TaqMan® Universal PCR Master Mix products impacted by the manufacturing site change include:

Product Name SKU
TaqMan® Universal PCR Master Mix,
1-Pack (1 x 5 mL)
4304437
TaqMan® Universal PCR Master Mix,
10-Pack (10 x 5 mL)
4305719
TaqMan® Universal PCR Master Mix,
10 Unit Pack (10 x 5 mL)
4318157
TaqMan® Universal PCR Master Mix,
1 Bulk Pack (1 x 50 mL)
4326708
TaqMan® Universal PCR Master Mix,
2-Pack (2 x 5 mL)
4364338
TaqMan® Universal PCR Master Mix,
5-Pack (5 x 5 mL)
4364340
TaqMan® Universal PCR Master Mix,
No AmpErase® UNG, 1-Pack (1 x 5 mL)
4324018
TaqMan® Universal PCR Master Mix,
No AmpErase® UNG, 10 Unit-Pack (10 x 5 mL)
4324020
TaqMan® Universal PCR Master Mix,
No AmpErase® UNG, 1 Bulk Pack (1 x 50 mL)
4326614
TaqMan® Universal PCR Master Mix,
No AmpErase® UNG, 2-Pack (2 x 5 mL)
4364341
TaqMan® Universal PCR Master Mix,
No AmpErase® UNG, 5-Pack (5 x 5 mL)
4364343

For Research Use Only. Not for use in diagnostic procedures.