Our certified clean room facilities, ISO9001 quality management system and extensive R&D experience enable us to produce the highest quality products for pharma, molecular diagnostics and for life science research. At Fermentas we work closely with our partners at the R&D and production levels to provide value added customized solutions backed by the best possible support and service.

Technology Development and Custom Manufacturing

Our core competences are:

• Purification of native and recombinant proteins.
• Plasmid DNA preperation (pharmaceutical grade meeting FDA and EU guidelines, transfection grade & research grade).
  
• RNA production and purification.
• Process development.
• Protein, DNA and RNA ladders.
  
• in vitro protein evolution (reverse transcriptases and DNA polymerases).
• Pilot-scale fermentation & production of biomass.
• Processing of nucleic acids by enzymes.
  

Our capabilities include:

• Production according to IVD and GMP guidelines and for research use only (RUO).
  
• Standard and customized, ISO9001 compliant QC release methods.
  
• ISO13485 and GMP compliant documentation and standard documentation for RUO products.
• Custom formulations for over 700 standard products.
• Vialling, labeling and packaging according to requirements.
  

In addition, more than 700 Fermentas catalogue products are available for customization:

• protein, DNA and RNA ladders and markers,
• dNTPs, NTPs and modified nucleotides,
  
• DNA and RNA polymerases,
  
• DNA/RNA modifying enzymes,
  
• restriction enzymes,
  
• products for:
  
  • PCR, qPCR, RT-PCR,
    
  • molecular cloning,
    
  • nucleic acid purification,
    
  • protein purification and analysis,
    
  • molecular labeling and detection,
    
  • in vitro transcription,
    
  • transfection.

QUALITY You Can Count On

Products are manufactured in class D clean room facilities, qualified and certified as per EU directives and ISPE guidelines, which are prerequisites for GMP manufacturing.
Quality assurance is carried out according to ISO9001 quality and ISO14001 environmental management systems, guaranteeing batch-to-batch reproducibility.
Integration of our clean room and ISO systems ensures stability and the absence of contaminants in all of our products.
We welcome our partners to audit our state-of-art manufacturing facility in Vilnius, Lithuania.

Complete Process and Product Documentation

Development and manufacturing of every product is meticulously recorded and documented according to your requirements.
Products are supplied with a certificate of analysis detailing the conditions and results of quality assurance tests and upon your request with batch records allowing full traceability of all parameters.
NDAs, CDAs, TTAs and MTAs are provided upon request.

We welcome your requests by e-mail: oem@fermentas.com