Contact us at 1-800-477-4839 for Information/Pricing!
Labeling of your proteins/peptides/antibodies with your choice
of radioisotopes according to your specifications. Aseptic filling with terminal sterilization and
lyophilization to include inert atmospheres.
FDA Validation Studies
Perform your validation according to your specifications and in accordance with
cGMP/GLP/USP and FDA regulations.
Contract Drug Manufacturing
Use our FDA registered facility for the drug manufacturing
of radiopharmaceuticals and pharmaceuticals.
Iso-Tex Diagnostics, Inc. operates a cGMP
Perform your testing according to your specifications in accordance with
cGMP/GLP/USP and FDA regulations. Such tests include LAL (Gel Clot / Turbid metric), / Photometric Sterility
(Direct inoculation / Membrane filtration), HPLC, ICP, AA, Sterilization, Refractive Index,
Lyophilization, Bioburden, Polyacralimide Gel Electrophoresis, Spectrophotometers
and various others.
*LAL (Endotoxin) testing of radioactive and non-radioactive materials.
Gel Clot method or Turbidmetric (To include Inhibition enhancement testing)
*Sterility testing of radioactive and non-radioactive materials.
Membrane filtration and Direct inoculation methods (To include bacteriostasis/fungistasis)
*Bioburden in accordance with USP <61>
*Vitek - for automated bacterial identification
*ICP (Inductive coupled plasma) for determination of heavy metals
*AA (Atomic Absorption Spectrophotometer) for determination of heavy metals
*HPLC - High pressure liquid chromatography
*Lyophilization - to include inert atmospheres
*Terminal sterilization (Dry heat and Steam)
*Polyacralimide Gel Electrophoresis
*Animal facility to include Bio-Distribution studies
All testing can be performed on radioactive samples in house NO OUTSOURCING REQUIRED!
Key Benefits/Other Capabilities
Multi-Curie Isotope License
Controlled Substance License (DEA)
Able to perform any type/size labeling requirement
Over 50 years experience performing labeling of peptides, antibodies and antigenic materials
Class 100 - 10,000 cleanrooms
Dedicated labs for each individual production
Dedicated quantitative/qualitative testing equipment for each individual product
Able to perform sterility and endotoxin testing on radioactive and non-radioactive samples
Past and Present Clients
Boston Life Sciences
LSU, YALE, AMERSHAM
Fred Hutchinson Cancer Center
Baylor Medical Center
Actinium Pharmaceuticals/Memorial Slone Kettering
Cell Point/MD Anderson Hospital
AND MANY OTHER RADIOPHARMACIES