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Manufacturing Grades

Get set up to scale with

our flexible manufacturing grades

 

Not having the right manufacturing grade at the right time can slow you down by causing issues with your process or technology transfer. That's why we offer a spectrum of manufacturing grades to give you flexibility in the early stages of your process development while setting you up for a seamless transition to commercialization.

Our unique RUO+ offering combines research-grade flexibility with clinical-grade production. Manufactured in the same facilities and using the same equipment as GMP-grade products, RUO+ is an efficient and cost-effective solution that provides comparable quality without the added documentation and testing requirements that GMP demands.

Our most flexible option, designed to efficiently support your early-stage research and product development while ensuring you get results you can trust.

For those moving into process development or entering preclinical trials, RUO+ offers a flexible and cost-effective solution that sets you up for a seamless transition to GMP.

If you are engaged in commercial production, GMP-grade products will meet your rigorous manufacturing and documentation standards.

Seamless scale up

We make it easy to move through the clinical pipeline

Accelerate your breakthroughs with off-the-shelf RUO solutions during discovery, then transition to custom RUO+ production for preclinical trials.

 

When you are ready to transition to GMP-grade products for commercial production, we can perform additional testing and provide the documentation needed to meet your requirements.

Find out if RUO+ is right for you
Our RUO+ manufacturing grade shares the most critical production steps with GMP-grade products. This helps minimize risk and streamline your transition to GMP, while increasing flexibility and containing costs.  
 

  • We use the same validated equipment, processes, and utilities for both RUO+ and GMP production, including raw material sources and quality control, lot and process traceability, and document and process control.

  • Products can be manufactured in animal-free and endotoxin-controlled facilities.

  • We offer on-floor quality oversight for every batch (IPQA).

Talk to our experts today

Explore our products

We offer a wide variety of off-the-shelf formulations in a range of formats. All our products are also fully customizable—our experts can help find the ideal fit for your application and efficiently manufacture your custom solution.

Start your custom order