Therapeutic cGMP Manufacturing

We offer single-batch or multiple-batch synthesis for IND-enabling tox studies and early phase clinical studies in dedicated GMP manufacturing facilities. With a wide variety of synthesis scales so that you can get just the amount of material you need for your particular study. We provide drug substances plus supporting batch records to streamline the IND submission process and carry you through to clinical trials.

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State-of-the-Art Facility

Our 2,000 square foot cGMP manufacturing facility is available for therapeutic products and is ISO certified by Lloyd’s Register. The controlled labs feature:

  • ISO Class 7 and Class 8 clean rooms
  • Compliance with ICH Q7, Section 19 cGMPs
  • Single pass, HEPA filtered air system
  • Routine monitoring for temperature, pressure, humidity, and particle count
  • Fully gowned staff

Getting Started with Therapeutic cGMP 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

Available Products

Manufacturing of therapeutic grade materials is available for:

  • mRNA
  • Long RNA
  • Oligonucleotides
  • Nucleotides and nucleosides
  • Aptamers

Inquire About Therapeutic Manufacturing

To begin discussions and obtain a quote for your project, please send us a consultation request.

Request a Consultation