cGMP manufacturing of oligonucleotides and antibodies for diagnostic assays

Choosing a reliable and knowledgeable manufacturing partner early in the assay development program is a key step towards the successful launch of your diagnostic assay. EUROGENTEC maintains a proven track record of manufacturing the widest range of oligonucleotide modifications in the industry. We take pride in our SPF animal facility and our wide offering of monoclonal and polyclonal antibody programs for immunoassay applications.

Diagnostic oligonucleotide services

• Design of oligos for feasibility phase of R&D
  
• Manufacturing of cGMP oligos with a Quality Management System compliant to FDA 21 CFR Part 820 and the ISO132485:2003 quality standards for medical devices.
  
• Stability testing of oligos during validation phase of R&D
  
• Analytical Quality control of oligos, including:
  • MALDI-TOF or ESI Mass Spectrometry
  • HPLC and capillary gel electrophoresis
  • Direct oligo sequencing using enzymatic cleavage and MALDI-TOF
    
• Enzymatic tests for DNA-enzyme conjugates
  • Probe/dye activity, e.g.: fluorescence, signal-to-noise ratios, denaturation and melting profiles, bioburden
    
• Product delivery:
  • Customized mixtures of individual oligonucleotides
  • Conjugated oligonucleotides (HRP, AP, synthetic peptides, proteins)
  • Filling (lyophilized or in solution with customized buffers) and labeling according to customer needs.
  • Customized packaging and labelling
    
• Filling in dedicated room with HEPA air filter

Oligonucleotide manufacturing solutions

Three manufacturing processes are offered that are appropriate and optimal in quality and cost-effectiveness for each phase of product development and product launch. 
RESEARCH manufacturing is performed according to our standard process (ISO 9001:2000 certified), oligos are optimized for feasibility phase of R&D. 
The DIAGNOSTIC-Light process is proposed for prototype and validation phases of R&D. Manufacturing is compliant to FDA 21 CFR Part 820 and the ISO132485:2003 quality standards; documentation is condensed, thereby minimizing your costs. 
The DIAGNOSTIC process is proposed for R&D validation phase and product launch. 
Manufacturing is compliant to FDA 21 CFR Part 820 and the ISO132485:2003 quality standards; a full documentation package is maintained.

Diagnostic antibody services

Monoclonal antibody production

• In vitro production to gram scale
• ELISA testing
• Antibody labelling
• Antibody purification
• Custom hybridomas from Rat & Mouse

Polyclonal antibody services

• Polyclonal rabbit facility is SPF; capacity in 2007: > 4000 litres of serum
• Custom antibody protocols
• Specialized in the specific detection of modified antigens
• Other animals: mouse, rat, guinea pig, chicken, goat, sheep, horse, cow, llama
• Total IgG purification, specific IgG affinity purification, antibody labelling, ELISA testing, fragmentation, Methyl, Acetyl, Phospho-specific custom antibodies
• Unique Speedy program, offering a 28-day protocol in contrast to traditional 87-day protocols

For contact information, please refer to the Help & Technical Support page.