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Promega Corporation

Manufacturing, Custom + cGMP Capabilities

  • Chemistries for automation are tested in Promega labs

    Promega first certified to ISO standards in 1998. Currently all of our global manufacturing sites are ISO certified, ensuring high-quality, performance-tested product.

  • Artist rendering of the Feynman Center, Madison, WI

    The Promega Madison (USA) campus is the primary site for reagent manufacturing, dispensing and packaging as well as custom and contract manufacturing. It is also the site of a new state-of-the-art cGMP manufacturing facility, The Feynman Center.

  • Maxwell® CSC Instrument (only available in the US)

    Promega currently manufactures Class I Exempt Medical Devices (GPRs), CE-marked products for the European Market, and also produces IVD medical devices.

  • 330 liter fermentation vessel in the fermentation facility

    Manufacturing facilities include a fermentation plant and competent cell manufacturing labs. Fermentation volumes range from 20 to 2,500 liters, and the process is automated using programmable logic control (PLC) with batch data trending and history.

  • HPLC apparatus

    In the protein purification labs, the facility and staff purify milligram to kilogram quantities of proteins using affinity, ion exchange, and hydrophobic interaction chromatography methods.

  • Artist rendering of B-form DNA helix

    A team of highly skilled scientists manufacture DNA and RNA products using proprietary manufacturing and analysis methods. Our plasmid manufacturing process uses bioprocessing equipment in dedicated production labs.

  • Artist rendering of 3D protein structure of NanoLuc® Luciferase

    Our chemists synthesize a variety of specialized enzyme substrates including fluorophores and specialized luciferins for cell-based and reporter assays. Promega can manufacture bulk reagents from 0.5ml to 650 liters, and luciferase-based substrates can be lyophilized in batches up to 21,500 units.

  • Automated filling and capping of bottles in dispensing facility

    Customize any product. Change the volume, concentration or formulation, kit components, packaging or the quality assurance testing to meet a specific need.

  • People at a meeting

    Create a custom solution. Start with a dedicated team of R&D and manufacturing scientists and create novel reagents and technologies, glycerol-free reagents ready for further lyophilization, optimized high-throughput applications, or custom assays designed to meet a specific research need.

  • Dispensing technician in an environmentally-controlled space

    Genetic Identity products require unique manufacturing methodology. Staff handling these products, from bulk production through kit packaging are specially trained. Pre- and post-amplification processes are separated. Automated dispensing is used wherever possible to reduce the chance of human to product contamination, and bulk products are handled under controlled conditions.

  • A scientist uses a pipetter.

    The GloMax® Discover System multimode reader represents the perfect partnership of assay chemistries and instrumentation, providing laboratories a convenient, single-source solution for support for both instrumentation and reagents.

Map of Promega's locations worldwideWith 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 & 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 in an environmentally-controlled facility 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 certifications 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.
Artist rendering of the Feynman Center, Madison, WI This facility, The Feynman Center, due for completion in 2014 is a state-of-the-art cGMP manufacturing facility that will significantly increase Promega's capabilities.

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.

If you are interested in any of these or other options, please request information.

Customize What You Need

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
Dispensing technicians and equipment in a environmentally-controlled space

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 start-up 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 specifications 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: Custom 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.

Custom Capabilities Process

Manufacturing, Formulation and OEM Inquiries

Initial inquiry about a
Custom Request through the website,
email or sales representative.

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.

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.

Custom packaging
and kitting as required.

Safe and on-time delivery
of your custom solution.

24/7 Technical Support.

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Scientists at Your Service

Scientists at Your Service

We offer a range of services to help you succeed using Promega technologies. From product training to set up of automated systems and development of custom applications—our scientific support goes beyond the basics.

Ask us! We are here to help you.