Moravek Corporate Profile

Moravek
Moravek
577 Mercury Ln
Brea, CA 92921
United States
Phone: Tel: (714) 990-2018
Fax: (714) 990-1824
Website: www.moravek.com/
Moravek is a leader in API GMP solutions, with the ability to prepare 14C and 3 H radiolabeled APIs for Phases 0, I, and II mass balance and microdosing (Phase 0 and Phase I) studies. We perform GMP synthesis, puri cation, testing, and QA release in compliance with FDA Phase 0, I, and II GMP guidance (ICH Q7 Section 19). In our GMP synthesis, puri cation, testing, and QA release processes, we analyze radiolabeled APIs that have been produced and puri ed under GMP conditions. These compounds are analyzed on qualified analytical instrumentation and are supplied with a complete batch record, which includes documentation of the synthetic, puri cation, and analytical processes from start to finish.

Company Description

Moravek is a leading provider of high-quality carbon-14 and tritium labeled compounds to researchers worldwide and is one of the most trusted contract development and manufacturing organizations offering radiosynthesis services. Moravek specializes in the custom production of GMP 14C-labeled APIs that are manufactured in compliance with U.S. Food and Drug Administration guidance ICH Q7 Section 19 and intended for use in early phase clinical trials. Moravek also offers non-GMP custom synthesis services and an extensive catalog of non-GLP radiolabeled (14C or 3H), stable-labeled (primarily 13C, 2H, and/ or 15N), and non-labeled compounds to suit a wide variety of research needs.

Company Background

In 1975, Moravek began offering custom carbon-14 and tritium labeling services. With decades of consistent growth and commitment to the manufacture of high-quality labeled compounds, Moravek is an exceptionally capable and responsive provider of radiolabeled, stable-labeled, and non- labeled compounds in support of both clinical and non-clinical research efforts.

Facilities

Moravek currently operates out of two locations on the west coast of the United States. The main facility in Brea, California is equipped with four ISO Class 7 cleanrooms and over 60 fume hoods. In order to meet the increasing demand for radiolabeling services, Moravek recently acquired and is currently developing a third location to include twelve ISO Class 7 cleanrooms and over 110 fume hoods.

Services & Capabilities

• Custom GMP manufacturing of 14C-labeled APIs
• Custom non-GMP manufacturing of radiolabeled (14C or 3H), stable-labeled (primarily 13C, 2H, and/or 15N), and non- labeled compounds
• An extensive catalog containing over 2,000 high-quality radiolabeled, stable-labeled, and non-labeled compounds intended to support non-GMP and non-GLP research efforts
• Analytical services, including NMR, MS, Headspace GC, HPLC, UHPLC, ICP-MS, XRPD, FTIR, Karl Fischer, and more
• Method transfer services
• Stability studies, including secure storage in Rees Scientific monitored environments
• Data generation and storage solutions compliant with 21 CFR Part 11, such as Agilent’s OpenLab Enterprise Content Management System
• Comprehensive logistics services, including worldwide shipping, temperature tracking, and chain of custody

Moravek
Moravek
577 Mercury Ln
Brea, CA 92921
United States
Phone: Tel: (714) 990-2018
Fax: (714) 990-1824
Website: www.moravek.com/

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