Validated Antibody Manufacturing
Fortis combines 50+ years of experience in custom antibody development and manufacturing with the ability to provide complete, end-to-end solutions for validated antibodies under our quality management systems that meet the requirements of the US FDA’s Quality System Regulation (QSR) (21 CFR Part 820) and ISO 13485.
Our processes specialize in producing small quantities (< 1g) of validated antibodies to support the early development of diagnostic assays or companion diagnostics for novel therapeutics.
A number of our development and production facilities are ISO 13485:2016 certified and been inspected by FDA for compliance to the QSR.
Why choose validated antibodies? Validated antibodies are crucial for generating accurate and reliable scientific results and can ensure the specificity, sensitivity, and reproducibility of the antibodies; thereby minimizing the risk of false negatives and false positives.
Why chose a supplier with a QSR compliant quality system and ISO 13485 certificate? Both the QSR and ISO 13485 provide a commitment to quality and continuous improvement. More importantly, adopting QSR and ISO 13485 provide a practical foundation for manufacturers to demonstrate that they have met the regulatory obligations in the US and around the world as well as demonstrate a commitment to the safety and quality of medical devices. Having both already in place puts you well on your way to commercializing your products.
Your project may start with:
- Any monoclonal antibody available in our catalog,
- A known DNA or amino acid sequence of an antibody of interest, or
- A custom monoclonal antibody development project.
As a validated antibody customer, you will receive complete documentation associated with the validation of your antibody, lot traceability, a certified supply chain, and validated manufacturing processes generated with the infrastructure from our QSR and ISO 13485.
Contact Fortis to discuss your QMS manufacturing needs.
Related Services
Fortis provides vertically integrated solutions for the diagnostics industry. We can provide additional raw materials for diagnostic manufacturing, diagnostic CDMO services, and GMP production of nanoparticles and bulk enzymes and master mixes.
By clicking “Acknowledge”, you consent to our website's use of cookies to give you the most relevant experience by remembering your preferences and to analyze our website traffic.
