Contact us at 1-800-477-4839 for Information/Pricing!

Radiolabeling Services

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

facility.

Testing

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)

*Spectrophotometers

*Refractive Index

*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

  • Aseptic fill

Past and Present Clients

DAXOR CORP.

 

Peregrine Pharmaceuticals

 

QOL Medical

 

Questcor Pharmaceuticals

 

NASA

 

Proxima Therapeutics

 

Boston Life Sciences

 

CYCLOTOPE

 

BERLEX

 

LSU, YALE, AMERSHAM

Northstar

Actinium Pharmaceuticals

Fred Hutchinson Cancer Center

Baylor Medical Center

Abott

LSU

Iso-Ray Medical

LSK/Utah

Actinium Pharmaceuticals/Memorial Slone Kettering

Iso Therapeutics

Clear Vascular

Cell Point/MD Anderson Hospital

RadioMedix

Bradmer Pharmaceuticals

AND MANY OTHER RADIOPHARMACIES

Contact us at 281-482-1231