GMP Radiosynthesis Services
In the development of drugs for human use, FDA requires that
absorption, distribution, metabolism, and excretion (ADME) studies
be conducted as Phase 1 investigations prior to more extensive
clinical trials. These ADME materials must be manufactured in
compliance with escalating Good Manufacturing Practice requirements
including well defined documented procedures, adequately controlled
equipment, and accurate and consistently recorded data from
production and testing. Consistent with the stage of clinical
development, the intent of these requirements also applies to the
synthesis of radioactive drug substances. This has compelled the
creative integration of escalating GMP with the many challenges
already inherent in radiosynthesis and analysis. Also, because of
the time sensitive nature of these expensive human studies, a
further demand facing organizations conducting in Phase 1 is the
adherence to strict and absolute deadlines. To assure compliance
and to help meet aggressive deadlines, our laboratories have
performed GMP* synthesis and analysis appropriate for Phase 1
studies for decades and have participated in the evolution of this
important service for the pharmaceutical industry.
As proof of our commitment to you, PerkinElmer is able to help you
meet this goal by offering GMP custom services including:
- Protocol Creation (synthetic protocol write-up)
- Custom Synthesis of the radioactive product
- Radiochemical Stability Testing**
- Special Packaging
- Analytical Services
- Radiochemical, chemical and chiral purity by HPLC
- NMR
- Mass Spectrometry
- UV-Vis Spectrometry
- Melting point
- Thin-layer chromatography
- Gas Chromatography
- Radio assays
*Consistent ICH Q7A, Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients, August, 2001, Section 19,
API's for Use in Clinical Trials. PerkinElmer Life and Analytical
Sciences has established a custom radiosynthesis process which
provides acceptable GMP compliance and the assurance of quality for
early drug studies.
**The purpose of radiochemical stability testing is to
provide an indication of how the purity of the radiochemical varies
with time under the influence of various temperatures during the
short period from time of synthesis to investigational use. The
study is not intended to establish an expiration date nor does it
replace a formal stability study for the drug product.