About Us

Our Mission

To support worldwide clinical and non-clinical research efforts by providing high-quality radiolabeled, stable-labeled, and non-labeled compounds.

Our Products

Moravek offers the production of radiolabeled (carbon-14 or tritium), stable-labeled (primarily carbon-13, deuterium, and nitrogen-15), and non-labeled compounds.  

Production may be carried out at one of three quality levels listed below to suit a variety of projects and budgets. 

Quality Level 3
Quality Level 2
Quality Level 1

Quality Level 3 – GMP grade material suitable for use in humans

GMP grade material is manufactured for its intended use in early phase clinical trials following U.S. Food and Drug Administration guidance ICH Q7 Section 19. GMP production is carried out in a certified ISO Class 7 cleanroom and analysis is performed with qualified instrumentation. The Quality Assurance team designs, implements, and periodically reviews comprehensive standard operating procedures that govern all aspects of GMP manufacture. Extensive documentation, generated and reviewed by Quality Assurance, is provided certifying that the material is suitable for use in humans.

Learn More About GMP 14C-Labeled APIs

Quality Level 2 – GLP grade material not suitable for use in humans

GLP grade material is manufactured following standard operating procedures for many aspects of production, including cleaning of the fume hood and glassware as well as thorough documentation of the production process. Analysis of the final product is performed with qualified instrumentation and a Certificate of Analysis is provided listing the results of analysis.

Quality Level 1 – Non-GLP grade material not suitable for use in humans

Non-GLP grade material is manufactured without following standard operating procedures or any production process documentation requirements. Analysis is performed using non-qualified instrumentation and a Certificate of Analysis is provided listing the results of analysis. Non-GLP grade material is an economical option that is best suited for non-GLP and non-GMP research efforts that do not require extensive documentation.

Key Facts

Nearly unlimited custom manufacturing options

Moravek’s experienced radiochemists are skilled in a wide variety of chemistry techniques and are able to synthesize nearly any custom labeled compound. Additionally, Moravek has a license from the U.S. Drug Enforcement Administration and is able to manufacture and handle all Schedule I – V controlled substances.

Exceptional staff

Over 90% of Moravek’s growing staff of radiochemists hold advanced degrees in chemistry. Our Quality Assurance team members have many years of experience in GMP API manufacturing and provide the necessary training on our Quality System for all of our staff members. Our dedicated Proposal Development Coordinators will work with you to design an efficient campaign that meets your needs and a Project Manager will be assigned to your project to provide periodic updates and answer your questions.

State-of-the-art facilities

Moravek’s main facility has four ISO Class 7 cleanrooms available for GMP production. Moravek also has a well-equipped Quality Control laboratory, containing a broad range of qualified instruments suitable for use in the manufacture of GMP materials. Analytical data for GMP campaigns is stored using 21 CFR Part 11 compliant data solutions, such as Agilent’s Enterprise Content Management System and Rees Scientific’s Environmental Monitoring System. The entire facility is backed up by a Cummins 500-kW generator, eliminating any issues that would be caused by an interruption of power.

A growth mindset

Since its inception in 1975, Moravek has been continuously investing in personnel and facilities to meet an ever-increasing demand for radiolabeling services. Moravek recently acquired a new 32,000 square foot location and is currently building out additional laboratory and administrative spaces.

Moravek is proud to receive feedback via Quality Assurance audits from our valued clients, including some of the world’s leading pharmaceutical companies. Moravek implements feedback as needed from our clients’ audits as well as annual internal audits performed by our Quality Assurance team. We are always striving to improve our services.

Reliability backed by experience

  • Over 2000 custom syntheses with carbon-14
  • 99% custom synthesis success rate
  • Over 100 GMP 14C-labeled APIs

Our History

1975
Moravek begins offering radiolabeling services in City of Industry, California
1980
Moravek moves to its main facility in Brea, California
1995
Moravek is awarded the final of several Small Business Innovation Research grants totaling nearly one million dollars
2005
Moravek expands production by adding 18 fume hoods
2008
Moravek adds an additional 18 fume hoods and a second NMR
2009
Moravek builds its first ISO Class 7 cleanroom
2012 - 2013
Moravek adds its second and third ISO Class 7 cleanrooms. 
2020
Moravek adds its fourth ISO Class 7 cleanroom.
2021
Moravek acquires and begins developing a new 32,000 square foot facility with additional laboratory and office space.
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