Rekom Biotech is committed to ensure the highest quality level in the design and manufacturing of our IVD reagents. Our products are designed, developed, manufactured and distributed according to our Quality Management System, that is certified by ISO 9001 and ISO 13485 standards. Our IVD reagents are always manufactured according to Standard Operating Procedures (SOPs) and undergo rigorous quality controls in our laboratories. You can check our system policy if you please.
We are authorised to work with genetic modified organisms (GMO), with the license number A/ES/19/I-22, issued by National Biosafety Commission.
We are registered as a Innovative SME.
Each lot is subjected to various quality controls:
As the determination of accurate extinction coefficients is straightforward, ultraviolet absorption spectroscopy is preferred over chemical methods, such as the Lowry or Bradford methods. The measurement of the protein concentration is performed with the theoretical extinction coefficient of the recombinant protein obtained from Gill and vonHippel, 1989.
However, for proteins that do not contain any Trp residues, experience shows that this could result in more than 10% error in the computed extinction coefficient. Therefore, we measure the protein concentration by using the colorimetric assay based on the interaction between Coomassie brilliant blue and the arginine and aromatic residues (Bradford Method) with a maximum absorption shift from 470 nm to 595 nm (Bradford, 1976).
Reproducibility analyses are performed by SDS-PAGE, SEC and ELISA assay. Excellent replicability of the production process.
Relative stability with immunoassay analysis at different ambient conditions is performed.
For recombinant proteins produced in Pichia pastoris, the N-glycosylation and O-glycosylation are analysed.
Our in vivo monobiotinylated antigens are analysed with a western blot assay with conjugated streptavidin (A) and several ELISA assays (indirect ELISA assay in streptavidin-coated microtiter plates, capture ELISA assay with the biotinylated recombinant antigen as detector and double-antigen-sandwich ELISA assay (B)).
As an internal quality control of an ELISA capture format, we also conjugate our antigens with peroxidase as internal quality control by using the biomarker as a developer. We perform a capture ELISA assay by using a commercial test and a double-antigen-sandwich ELISA assay.