Beginning in early April, 2014, minor modifications will be made to the TaqMan® Universal PCR Master Mix and TaqMan® Universal PCR Master Mix, No AmpErase® UNG products. These modifications include transfer of manufacturing from Branchburg, NJ to Warrington, UK and changes in source/vendor for some raw material components.

In recognition of the importance of these products in existing protocols, we have implemented additional QC testing of the products of our internal manufacturing processes and conducted extensive studies to demonstrate functional equivalency. In our hands, these changes have been shown to have no effect on the overall functional characteristics of the master mix. Detailed information can be found below.

The following describes details of what has been modified and improved, and provides additional information about what has remained the same as a result of the transition.

Modified:

Manufacturing site

  • Manufacturing has transitioned from Branchberg, NJ (Roche Molecular Systems, third party manufacturer) to Warrington, UK.

Packaging

  • Box and tube labels, lot number format and product insert have been revised to reflect the transition.

Source of raw materials

  • Change in source/vendor for some components (such as dNTPs, UNG and AmpliTaq Gold® DNA polymerase).

Shipping

  • The shipping conditions for the TaqMan® Universal PCR Master Mix, No AmpErase® UNG products have been changed from dry ice to frozen gel packs to align with those of the TaqMan® Universal PCR Master Mix.

Improved:

  • Additional analytical and functional QC tests have been added to the manufacturing process to help ensure the continued high level performance of the product. The CoA has been modified to include the additional analysis.
  • The shelf life has been extended from 1 year to 1.5 years.

Additional Information:

  • Although the source of raw materials has changed, no changes have been made to the product formulation of these master mixes.
  • Each product configuration is available and orderable using the same SKU.
  • The original QC specification from Roche Molecular Systems is included on the CoA.

Functional equivalency:

We have conducted extensive internal studies to compare the performance of the master mixes manufactured in-house to master mixes manufactured by our contract manufacturer, and these studies have demonstrated no discernible difference in performance.  The functional equivalency reports will be made available on the product web pages.

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 a limited time, and beginning in early April 2014, customers can request to purchase Roche-made lots for side-by-side comparison with in-house made master mix to support laboratories through the transition and help ensure a smooth and seamless conversion. The in-house made master mix will be available for sale no earlier than April 2, 2014. For customers located in 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. The Roche-made material is in limited supply and this offer will continue while supplies last.

If you have any questions on this change contact your local customer support or your sales representative.