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Manufacturing and Custom Capabilities

Automated dispensing equipment

With a portfolio of more than 3,000 products covering the fields of genomics, protein analysis and expression, cellular analysis, drug discovery and genetic identity, Promega Corporation is a global leader in providing solutions and technical support to the life science, clinical, pharmaceutical R&D and forensic markets. Headquartered in Madison, WI, Promega has branches in 15 countries and more than 50 global distributors serving 100 countries.

Complete Technology Portfolio and Manufacturing Capability

Core Technologies

  • Integrated automation and instrumentation
  • Nucleic acid purification and detection
  • Amplification systems
  • Organic chemistry
  • Protein analysis
  • Bioluminescent assays
  • Enzyme purification
  • Human genetic identity products
Automated dispensing equipment

Automated dispensing equipment in an environmentally controlled facility

Full Manufacturing Capabilities

  • Flexible manufacturing and dispensing lines
  • Manufacturing within environmentally controlled spaces
  • Formulation and dispensing to requested volume specifications, including semi-automated filling for low-volume units
  • Automated packaging of ambient kits—vision systems to perform 100% inspection of kit components and label content
  • Separation of pre- and post-amplification processes
  • State-of-the-art bioprocess equipment for consistent, high-quality product

Our Expanding Manufacturing Facilities are Certified to Quality Standards that Ensure:

  • On-Time Delivery
  • Continuity of Supply
  • Consistent Product Performance
  • Reproducible Processes with Change Control
  • Product Design that Meets Your Specifications

A Commitment to Compliance

Strict quality standards and production requirements ensure on-time delivery of high-quality, performance-tested products. ISO certification is one example of our commitment to quality.

A Tradition of Quality

Certification to international quality standards (ISO) exemplifies our commitment to our clients, our business and to all those who rely on and benefit from the use of our products. You can be confident in our ability to manufacture products and components reproducibly and provide the required quality documentation.

  • Promega first certified to international standards for quality management systems in 1998.
  • The Promega Madison, USA facility, maintains ISO 13485 certification for the manufacture of products intended for in vitro diagnostic (IVD) use.
  • cGMP-compliant products are manufactured under strict controls to guarantee consistent, high-quality reagents.
  • Data output and sample tracking capabilities on our IVD nucleic acid extraction instruments meet 21 CFR Part 11 requirements for electronic records.
  • Currently 15 Promega facilities around the world have certified to either the ISO 13485 or the ISO 9001 standard.
The Feynman Center

This facility, The Feynman Center, completed in 2014, is a state-of-the-art cGMP manufacturing facility.

Experience in Product Development and Delivery

Promega has over 30 years expertise delivering reagents to life science researchers. In addition to our standard catalog products, we also contract manufacture products or components for other IVD or medical device manufacturers, including:

  • Clinical sample concentrator kits (DNA and RNA)
  • Components for laboratory-developed IVD tests
  • Amplification reagents and master mixes for molecular diagnostics

Promega Manufacturing Facilities

Our facilities meet or exceed quality standard requirements to ensure the on-time delivery of high-quality custom, bulk or specially designed products.

Complete Technology Portfolio and Manufacturing Capability

With customized kits and reagents you can spend more time on your research and less time getting ready. We offer custom services on an expansive line of products for genomics, proteomics, cellular analysis and high-throughput screening.

Customize what you need.

Start with an existing Promega product and change:

  • Volume, concentration or formulation
  • Kit components
  • Quality assurance testing to meet a specific application
Illustration of vials and flasks

Benefit From a Dedicated Team of R&D and Manufacturing Scientists to Create:

  • Novel reagents and technologies
  • Glycerol-free amplification reagents
  • Product formats optimized for high-throughput applications
  • Custom assays
  • Specialty enzymes
Benefit from a team of R&D and manufacturing scientists

Choose From a Complete Range of Dispensing and Packaging Options

  • Format: Specify dispensing needs from microliters to multiple liters
  • Container Size: Select from over 80 options of vials and containers
  • Labeling: Customize labeling with specific information
  • Packaging: Choose from heat-sealed or vacuum-sealed pouches and custom-designed boxes
  • Automated Format Options: Specify requirements for multiwell plate dispensing and cartridge options for automated platforms

Providing a Complete Solution: From Initial Inquiry to cGMP Manufacturing

A startup clinical diagnostics company had been recommending commercially available systems for RNA purification to prepare samples for testing in a molecular diagnostics assay to be marketed to clinical laboratories. However, the commercially available systems were not giving the desired results. They approached Promega about manufacturing an RNA purification system for them.

We provided test materials and offered suggestions for optimizing results. The components were manufactured to the customer's specification and specific components were sourced to meet the customer's needs for the finished kits. Promega's custom manufacturing team also worked to provide the required bottles, labels and packaging materials for the finished kits.

To meet the specialized requirements for getting a sample preparation kit to market, Promega provided multiple product lots to support the customer's development work and clinical trials, and helped the customer develop and implement a product-specific validation plan for cGMP manufacturing of the completed sample preparation kit.

This customer is now working with Promega on a new initiative to incorporate additional components for downstream analysis to create a sample-to-answer kit.

Simplifying Work in a Cost-Effective Manner: Customer PCR Master Mixes

A global molecular diagnostics company was developing a multiplex amplification-based clinical assay. Historically, the customer purchased Taq DNA Polymerase and dNTPs separately from another supplier to manufacture a master mix that was provided as a component in their kit.

We offered them an opportunity to customize a PCR master mix based on their formulation that would work well for a multiplexed PCR format at a competitive price per reaction.

Understanding that conditions need to be optimized with a new supplier, Promega formulated an evaluation batch of master mix specifically for testing and optimization purposes. The PCR Master Mix worked well in the customer's hands, even for difficult samples.

Promega capabilities allowed the manufacture of enough Master Mix for an entire year's supply in a single batch, allowing the customer to reduce the validation requirements for each newly requested shipment.

Furthermore, we were also able to accommodate prescheduled shipments of this single lot throughout the year, increasing the simplicity of the ordering process.

Custom Packaging Design Saves Valuable Time and Resources

A major research institution placed a large order for CellTiter-Glo® Cell Viability Assay reagents, which are traditionally shipped with the individual glass bottles each wrapped with bubble wrap. For customers ordering extremely large quantities (e.g., a year's supply), unwrapping each individual bottle can be tedious and time consuming.

The Promega Field Application Specialist for the account worked with the custom operations team in Madison, WI, to see if packaging could be customized for this large order to reduce packing materials, ensure safe delivery of product, and save the customer time at unpacking.

The operations team worked to design a new packaging configuration that met Promega's stringent packaging requirements and protected the product from damage, as demonstrated by testing using our in-house shipping equipment. As a result this large order shipped in the new packaging, and the customer was able to unpack the entire shipment in under an hour.

Manufacturing and R&D Team Up to Meet Customer Requirements for 1-Step qPCR Reagents

A global molecular diagnostics company wanted to improve their existing assay platform by offering easy-to-use lyophilized reagents in single-reaction units. Their existing supplier was unable to meet their formulation requirements, resulting in a frustrating and costly situation. Promega provided small-scale batches of lyophilization-compatible formulations for the reagents for the customer to evaluate, with the capability of cGMP manufacturing of larger scale batches for use in the finished product. Our R&D scientists worked with the customer's R&D group to optimize custom components, including GoTaq® polymerase and buffers their specific multiplex application. Within several months, cGMP-manufactured custom components were available for the customer.

Step 1
Initial inquiry about a Custom Request through the website, email or sales representative.
Step 2
Step 3
Consultation with cross-functional Promega team to discuss your request, specific requirements and determine the best options to meet your needs.
Assignment of Project Manager, Lead Scientist and team to manage your custom request.
Step 4
Step 5
If a custom formulation is needed, our staff will complete small scale manufacturing and testing of samples, optimization of reactions as required for your custom solution.
Large-scale manufacture and QC testing by our production staff.
Step 6
Step 7
Custom packaging and kitting as required.
Safe and on-time delivery of your custom solution.
Step 8
24/7 Technical Support.
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