GMP Oligos

Oligos Etc. offers full GMP (Good Manufacturing Practices) handling for your special diagnostic or therapeutic grade oligonucleotide needs.  We provide scales of GMP oligos from 1micromole up to 100 grams and can provide your oligos in a timely manner.  Contact us to discuss your project, pricing, and timing.  We will work with you on design, process development, regulatory issues, and production.

When you order GMP oligos, Oligos Etc. will manufacture them under a controlled quality program designed to meet cGMP (current Good Manufacturing Practices) standards for pharmaceutical, in vitro diagnostics, and medical devices (e.g., 21CFR820, 21CFR210, and 21CFR211).  Features of our quality program include regularly scheduled internal audits to ensure compliance with these federal regulations, and ongoing training of personnel to communicate these requirements.  The manufacturing and Quality Control (QC) groups monitor and test the products throughout the manufacturing process to ensure that each product meets pre-defined acceptance criteria.  As a final release criterion, the Quality Assurance (QA) team reviews the product documentation to verify that the requirements of the quality program have been met.  QA will generate a Certificate of Analysis when all release criteria are satisfied.

All steps in the GMP process are carried out in a separate area of over 6,000 square feet with adequate equipment, facilities, and trained personnel.  These oligonucleotide products are routinely analyzed by High Performance Liquid Chromatography, Capillary Electrophoresis, and analytical Gel Electrophoresis (PAGE).  In addition, analyses for other tests relevant to customer specifications can be arranged when requested (e.g., NMR, MALDI-TOF, etc.).  For oligos intended as a component of in vitro diagnostic kits, each batch of oligonucleotide is tested before aliquoting for individual kits.

We at Oligos Etc. are extremely flexible in meeting the needs of our customers.  Should you have specific requirements for the testing of your oligonucleotides, we are willing to prearrange specified testing beyond our standard testing regime.