In Conversation with Terri McDonnell, Senior Program Manager, Promega Corporation

In Conversation with Terri McDonnell, Senior Program Manager, Promega Corporation

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With more than 450,000 square feet of manufacturing space, including cGMP facilities, Promega Corporation has invested in the development and maintenance of state-of-the-art, high-quality manufacturing facilities. Promega headquarters in Madison, WI, maintains certification to ISO 9001 and ISO 13485 standards, as well as ISO 18385, which focuses on minimizing the risks of human DNA contamination in products. Currently, 15 Promega facilities around the world are certified to ISO standards. Promega offers a range of custom manufacturing services, from simple changes in dispensed size to uniquely designed products specifically adapted for individual client needs. Each client works with a lead scientist and dedicated custom manufacturing team. Customizable amplification reagents—in particular, PCR master mixes—are a key area of focus for the company.

What experience does Promega have devel­oping and manufacturing PCR master mixes?

Promega has 40 years of experience in developing and manufacturing amplification reagents to suit our customers’ specific needs. We are a primary manufacturer of amplification components. Therefore, we control all aspects of product manufacturing, from raw materials through finished product. This level of control eliminates uncertainty in your supply chain. Our PCR master mix portfolio contains preformulated master mixes that cover a spectrum of PCR performance capabilities for endpoint, multiplex, real-time, GC-rich and inhibitor-resistant amplifications.

What options does Promega have for customizing master mixes if a catalog option is not quite right?

Promega has many options for customizing PCR master mixes to meet your unique application requirements. For example, the final product format can be changed to accommodate your specific needs. The product can be dispensed into small vials or large bulk bottles, with over 80 choices of vials and bottles. Product can be labeled according to your specifications, including any private label requirements you might have, e.g., with your company logo. Dispensed product can be packaged into almost any format, including packaging specifically designed for you. We have packaging engineers who can help you choose the product formats that work best for you.

In addition, your assay may require a change to the product’s concentration; the formulation of the product remains constant, but you are either changing the product to be more concentrated or more dilute. This customization option is available for any amplification reagent.

Off-the-shelf PCR master mixes can leave you on the edge of performance. We can work with you to identify an optimal master mix composition of buffer, enzyme, and MgCl2 that helps you achieve consistent amplification performance specific to your application. You can start with an existing Promega catalog master mix to optimize the composition of an amplification reaction on your own, or you can accelerate your development by starting with our PCR Optimization Kit. Further, we can partner with you to manufacture a PCR master mix you’ve developed but may not have the capabilities to bring to market. You can benefit from a customer-centered quality system without having to build it yourself.

Why is Promega the partner to choose for PCR Master Mixes?

Promega has dedicated manufacturing suites for amplification reagents, separated by pre- and post-amplification processes. Unlike many others providing amplification reagents, Promega is also a primary supplier of high-quality deoxynucleotide triphosphates (dNTPs). These dNTPs have greater than 99% triphosphate content and are typically provided at a concentration of 100mM in water at pH 7.5.

If you have used the PCR Optimization Kit to determine your optimal PCR master mix formulation, that 2X PCR Master Mix can be manufactured under cGMP and shipped to you within 10 days of our receipt of your order. Your custom, made-to-order master mix is assigned a unique part number, specifically for you, making reorder of that cGMP-manufactured master mix fast and simple. Tap into an established ISO 13485-certified quality system with product traceability and manufacturing controls that ensures your custom product is consistently and reproducibly delivered to you.

We have branches in 16 countries with more than 50 global distributors serving 100 countries to deliver your custom PCR master mixes safely and on-time. Our fully controlled, reliable, end-to-end supply chain—from inventory management to warehousing, order processing, and distribution—ensures accurate and timely product delivery. We are IATA certified and provide flexible shipping options, depending on your needs.

Finally, Promega prides itself on our superior customer and technical support. Global support includes sales, technical support, custom consultants, clinical collaboration managers, field support scientists, application scientists, strategic collaborations teams, scientific training, and instrument services. Your custom solutions team of experts remain available for assistance after your order is delivered.

Whom do I contact if I want a customized master mix?

It’s easy to get in touch with our team of custom manufacturing experts. Just go to or e-mail [email protected] and one of our scientists will be in touch to discuss your needs, address your challenges, and serve as your champion in finding a custom solution.