Radiolabeling Services:
Contract Drug Manufacturing
Labeling of your proteins/peptides/antibodies with your choice
of radioisotopes according to your specifications. Aseptic filling, terminal and sterilization,
lyophilization to include inert atmospheres.
FDA Validation Studies
Perform your validation according to your specifications andin accordance with
cGMP/GLP/USP and FDA regulations.
Testing
Perform your testing according to your specifications in accordance with
cGMP/GLP/USP and FDA regulations. Such test 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.
Contract Drug Manufacturing
FDA Validation Studies
Iso-Tex Diagnostics, Inc. is a manufacturing company based in Friendswood, TX
.
We are a FDA registered facility for the drug manufacturing
of radiopharmaceuticals and pharmaceuticals.
Iso-Tex Diagnostics, Inc. operates a cGMP
facility and is a contract manufacturer.
Key Benefits
*Multi-Curie Isotope License
*Controlled Substance License (DEA)
*Able to perform any type/size labeling requirement
Capabilities
*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
AND MANY OTHER RADIOPHARMACIES
Testing
Key Benefits
*Specialized staff
*All testing can be performed in house NO OUTSOURCING REQUIRED.
*cGMP facility
Capabilities
*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
