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 A New Approach to Early Phase Therapeutic GMP Manufacturing

For over 20 years, we’ve been industry leaders synthesizing high quality research and diagnostic grade GMP material, especially difficult and unusual constructs. Now we’re combining our expertise with a new state-of-the art GMP manufacturing facility to expand our services into mRNA and oligonucleotide therapeutics.

We offer single-batch or multiple-batch synthesis for IND-enabling tox studies and early phase clinical studies. With a wide variety of synthesis scales so that you can get just the amount of material you need for your particular study. Because we don’t require large scale synthesis, we can deliver your material quickly and at an affordable price. We provide drug substances plus supporting documentation to streamline the IND submission process and carry you through to clinical trials—saving you time and money.

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State-of-the-Art Facility

Our new, 2,000 square foot GMP facility is dedicated to manufacturing therapeutic products and is ISO certified by Lloyd’s Register. The controlled labs feature:
  • Validated ISO Class 7 and Class 8 clean rooms
  • Compliance with ICH Q7, CFR 210 and other phase-appropriate GMPs
  • Single pass, HEPA filtered air system
  • Routine monitoring for temperature, pressure, humidity and particle count
  • Fully gowned staff
  • Facilities, processes, equipment and computerized systems are validated (IQ/OQ) and maintained in a validated state
Available Products

Manufacturing of therapeutic grade material is available for:
  • mRNA
  • Long RNA
  • Oligonucleotides
  • Nucleotides & nucleosides
  • Aptamers

Getting Started with Therapeutic GMP Manufacturing

To begin discussions and obtain a quote for your project, please send us a request. We’ll start with an intake meeting, where we’ll discuss your project, expectations and timelines. From there, we’ll work with you to determine the most effective and efficient process for your particular project. Although we may customize each project to meet your specific needs, the basic steps are outlined below.

  • Information transfer
  • Technology transfer
  • Trial synthesis
  • Scale Up
  • Finalize process and documentation







 

 

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