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GMP Manufacturing

Making GMP manufacturing seamless

Whether you are already in commercial production or want to set yourself up to scale from research to GMP-grade reagents, our experts will work with you to understand your goals and adapt to your processes. Our state-of-the-art ISO 13485:2016 certified facility is purpose-built to support your manufacturing needs, and we offer ready-to-use GMP-grade products for your convenience.

THE MODULAR MANUFACTURING DIFFERENCE TRANSITIONING FROM RUO TO GMP See our GMP-grade products

DISCOVER THE MODULAR MANUFACTURING DIFFERENCE

 

 

Where science and

engineering meet

Our unique modular manufacturing platform can be easily configured to make your custom GMP products on demand, allowing us to support emerging therapeutic modalities, like cell and gene therapy.

 

By combining the precision and flexibility of our platform with our rigorous quality management system, we can manufacture custom products quickly without compromising quality. Whether you are looking for standard solutions or complex formulations and formats, we make custom products at the scale you need when you need them.

State-of-the-art facilities

Purpose-built to support you from early-stage research through commercialization, our new ISO 13485:2016 certified facility features over 10,000 square feet of ISO 7 and 8 cleanrooms. Every detail was considered for production quality, efficiency, accuracy, and throughput. With cutting-edge automation, continuous production, and burst capacity for lot sizes up to 2,000 L, we can quickly turn around high-quality GMP-grade reagents that are tailor-made for your specific application.

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Built on industry expertise

Our facilities and QMS are designed by our team of experts who have decades of experience working in leadership positions across the global pharmaceutical industry. They are here to answer any questions, and help find the best solution for your specific application, offering their unique expertise in everything from optimizing reagent formulations to gene therapy bioprocessing scale-up.

Meet our experts

Made to your specifications

Our solutions are fully-customizable, from formulation to QC testing to documentation and labeling. Our on-site engineers continuously work to design formats that function seamlessly in your hands, in your facility, and with your systems. We can accommodate your proprietary containers and are developing filling systems that can adjust to your changing needs.

Our custom process

Transitioning from RUO to GMP

We understand the different challenges you face as you transition from RUO to GMP and have the manufacturing, technical, and quality capabilities to support you. Whether you need 1 L of a standard research grade product in a bottle or 200 L of a proprietary formulation in a single-use bag, we’ve designed our systems and processes to scale with your workflow.

 

If you are currently using research-grade products that you may need to transition to GMP in the future, we can help you plan by ensuring you are starting with the right reagents and processes to scale with ease. Our flexible RUO, RUO+, and GMP manufacturing grades can help you work efficiently and contain costs as you move through the clinical pipeline.

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Quality control you can count on

All GMP-compliant products are manufactured in our state-of-the-art facility in purpose-built cleanrooms ranging from ISO 5 to ISO 8.

 

  • We follow USP <71> sterility guidelines
  • Quality tests include pH, conductivity, density, osmolality, TOC, nitrate, protease, DNase/RNase, bioburden, and endotoxins, growth promotion
  • Side samples can be sent with each lot for your testing requirements, in appropriate formats
  • All products are sterile filtered into bottles, tubes, and single-use bioprocessing bags
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Start with the right raw materials

We go beyond industry testing standards to ensure we are working with high-quality raw materials that will meet your requirements. Over the past 27 years, we have established a default library of raw materials that we have extensively tested for performance and quality. We can also help source and test specialized raw materials to meet your needs.

 

  • By default, we use USP and multi-compendial grade raw materials
  • All incoming raw materials used in GMP-compliant manufacturing undergo identity testing in a segregated raw materials sampling suite
  • Dedicated animal-origin-free (AOF) and endotoxin-controlled facilities
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The stability data you need

We know it's critical to have stability data for all your reagents so you can ensure effectivity and meet regulatory requirements. Our experts can design and perform a tailored stability study to assign, or extend, a shelf life for your custom GMP-grade products or for your specialized raw materials.

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Explore our GMP-grade reagents

We offer pre-specified GMP-grade products for your convenience, and our team of experts is here to help tailor, and efficiently manufacture, the ideal product for your application. We can customize everything from formulation to format to quality control testing and labeling.

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Do you have a tight timeline?

Talk to us about our Express•Tek℠ Production services. We can expedite your turnaround with pre-ordered raw materials, prioritized manufacturing, and overnight shipping. With this unique service, we'll get your custom formulation into production in days instead of weeks, guaranteed.

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Let us be your media kitchen

Let us make your custom, high-end media. We have the flexibility and scale to meet your GMP manufacturing needs, saving you the expense of equipment and facilities and helping you get more value out of your team’s time and skills.

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OUR EXPERTISE

Add our expertise to

your team

With over 27 years of experience manufacturing critical reagents for bioprocessing,

bioproduction, vaccine production, and diagnostics, you can rely on

getting consistent formulations in the quantities you need.

Consistent quality

 

 

Our QMS is designed to ensure you get the quality reagents you need to create safe, effective diagnostic and therapeutic products. From raw material testing and process controls to finished goods testing and product release, we deliver end-to-end quality. 

GMP compliant

 

 

We have been ISO 13485 certified since 2016, serving large and small customers across the life science industry. From standard culture media, reagents, and water to proprietary formulations, we manufacture all our GMP-grade products using stringent quality controls.

Fast turnaround

 

 

Getting the critical reagents you need should never hold up your development or production. Whether you want 2 L or 2,000 L, we can manufacture your custom GMP-grade products in weeks, not months. 

 

we're custom by default

Don’t see what you’re looking for?

 

Talk to our team about our custom solutions. We can partner with you so you can count on one trusted supplier from RUO to GMP.  

LET'S FIND YOUR SOLUTION