Notice of Manufacturing Site Transition
Notice of Manufacturing Site Transition for AmpliTaq® DNA Polymerase, AmpliTaq Gold® DNA Polymerase and a few other products on April 1, 2014
Beginning in April 2014, minor modifications will be made to AmpliTaq® DNA Polymerase, AmpliTaq Gold® DNA Polymerase, and a few other products. These modifications include transfer of manufacturing from a contract manufacturer in Branchburg, NJ to current Life Technologies manufacturing sites. In recognition of the importance of these products in existing protocols, Life Technologies has implemented appropriate QC testing of the products of our internal manufacturing processes and conducted extensive studies to demonstrate functional equivalency. These changes have been shown to have no effect on the overall functional characteristics of the products. Detailed information can be found below.
Products included in the manufacturing site change:
|N8080250||AmpliTaq Gold® DNA Polymerase||25,000 units (5 mL set)|
|N8080255||AmpliTaq Gold® DNA Polymerase with 10X buffer I
|N8080256||AmpliTaq Gold® DNA Polymerase with 10X buffer II and MgCl2||25,000 units|
What is being changed
Manufacturing of AmpliTaq® DNA Polymerase, AmpliTaq Gold® DNA Polymerase, GeneAmp® PCR Buffers, and the other products in the list above has transitioned from Roche Molecular Systems, a contract manufacturer in Branchburg, NJ, to Life Technologies manufacturing sites in Austin, TX and Carlsbad, CA, USA.
Boxes, tubes, labels, and product inserts have been revised to reflect the transition.
Source of raw materials
Change in source/vendor for some components (such as dNTPs).
Quality control (QC)
Following the transition of the manufacturing and QC of these products to Life Technologies, the COA will be updated to reflect the QC process.
What is staying the same
- Although the source of raw materials has changed, no changes have been made to product formulation.
- Each product configuration is available and orderable using the same catalog number at the same price.
- There is no change to the shipping conditions for any of the products listed above.
- We have implemented additional QC testing of the products of our internal manufacturing processes and conducted extensive internal studies to compare the performance of the products manufactured in-house to the products manufactured by our contract manufacturer, and these studies have demonstrated no discernible difference in performance.
- If you have any questions regarding this change, contact your local customer support or your sales representative.
- Please refer to the performance equivalency data for further details