Working to current GMP in an ISO and FDA licensed manufacturing facility clients have the reassurance offered by the technical abilities of experienced and well trained staff.
To be able to offer companies their own brand of reagents for Immunohaematology, Alba Bioscience can offer a wide range of monoclonal blood grouping antibodies, cell suspensions and control reagents in different formats. We provide ready to use finished reagents in vials or bulk quantities, as well as intermediates For Further Manufacturing Use (FFMU), all formulated to fulfil your requirements. Available in volumes that meet your needs. Please contact customer services to discuss.
Monoclonal Blood Typing Intermediate Products
Alba Bioscience provides blood typing intermediates For Further Manufacturing Use (FFMU) which are standardised cell culture supernatants from cell lines expressing human or murine monoclonal antibodies. These can be formulated into finished blood typing reagents by dilution, blending (if required) and addition of chemicals. Manufacturers can formulate fi nished reagents to suit their specific applications. All FFMU intermediates contain 0.1% (w/v) sodium azide as a preservative. Since these are derived from monoclonal cell lines, each batch will have similar potency and identical specificity. Potencies are assessed against a reference sample.
Ready to use Blood Typing Reagents
Based on our blood typing intermediates, Alba Bioscience has formulated a wide range of Blood Typing Reagents which will meet the requirements of the European Directive 98/79/EC. These reagents are offered as bulk quantities in different
fillings as well as standardised vials with droppers ready for labelling. Depending on the quantities required, Alba Bioscience can label these products in your own trade dress and assist with product and batch registration.
Anti-Human Globulin Reagents
We offer different monoclonal antibodies reacting with IgG or C3 as well as high quality blend products of rabbit and monoclonal origin. These reagents can be supplied as FFMU and as ready-to-use bulk.
Cell suspensions can be developed dedicated to the technique used. We offer 3% reagent red cells for use in manual tube techniques as well as 0.8% suspensions which can used in column agglutination technologies. Product range comprises of reverse typing cells, screening panels and antibody identification panels
Quality Control Reagents
Alba Bioscience was amongst the first manufacturers of a range of quality control reagents to be used during Immunohaematology testing procedures. Simulated Whole Blood Controls to be used as patient samples for the routine quality control on automated platforms can be developed according your specifications as well as sensitivity controls, weak IgG antibodies, to stress automated blood grouping systems. For proficiency testing Alba Bioscience provides EQAS (External Quality Assessment Samples) presented as Whole Blood Controls, serum samples, DAT samples and donor samples in different concentrations and specifications.