SingleFlowEx premium antibodies - Always look on the bright side of Flow
We developed the large portfolio of single-color antibodies for flow cytometry (pre)clinical analysis offered under our trademark SingleFlowEx.
SingleFlowEx reagents are specifically designed for use in laboratory-developed multicolor flow cytometry tests in order to examine samples derived from human body.
The versatility of multicolor flow cytometry tests affords outstanding power to be used in
- every stage of a drug or vaccine development program, from discovery, through to preclinical and into clinical testing (e.g. assess and understanding the immunogenicity and efficacy of a vaccine).
- development of clinically valid tests to make good healthcare decisions (e.g. diagnosis and follow up of primary immunodeficiencies, leukemias and lymphomas).
Good Manufacturing Practices (GMP)-premium antibodies
Either Contract research organizations (CRO)/pharma industry and clinical laboratories/health care providers require high degree of quality assurance for the purchased reagents in order to provide clinically valid test results. Therefore, SingleFlowEx reagents are designed and manufactured according to current Good Manufacturing Practices (GMP) in our FDA registered manufacturing site. Therefore, our products meet all the requirements on finished devices intended for in vitro examination of human specimens, including:
- Design controls (development of safe and effective product)
- Purchasing controls (monitoring of vendors and material quality)
- Production controls (testing, measuring, including validation activities)
- Product release (battery of stringent acceptance tests)
- Control of nonconforming product (including corrective and preventive action)
- Control of storage and distribution (ensuring product shelf life)
- Documentation (including design files, batch records, certificates of analysis)
- Personnel (highly qualified personnel receiving continuous training)
The integral part of the product design phase is the validation of each SingleFlowEx reagent in clinical laboratories directly by users, ensuring suitability to be used in robust and consistent flow cytometry tests developed in-house, also called Laboratory Developed Tests (LDTs).
Description of SingleFlowEx development and validation phases can be found HERE.
link na popis vývoje SingleFlowEx; v zásadě nějaká case study, optimálně pro nějaký zajímavý antigen, kde jsou hezká data z partnerské klinické laboratoře (třeba CD305 PE od Borského)
Lot-to-Lot Consistency and Reproducibility in performance
In order to produce accurate and reproducible results, laboratory requires reagents that maintain their performance characteristics with minimum lot-to-lot variability and reproducible fluorescence intensity over a time. It is known that monoclonal antibody conjugates are susceptible to variability that contributes to inconsistent results in assays using antibodies. We developed detailed working instructions and protocols that allow for the manufacture of SingleFlowEx reagents with excellent lot-to-lot consistency. Each new lot must pass stringent quality control specifications for physicochemical properties (absorbtion and emission spectra, homogeneity analysis by HPLC) and performance characteristics (staining patterns and MFI intensities by flow cytometry). New lots are also tested against reference lots to control for degree of variability.
Examples of Lot-to-Lot Consistency and Reproducibility in performance can be found HERE.
Bude tedy link na stránku/FAQ, kde budou data od vývoje o reprodukovatelnosti
Certificate of Analysis Specifications
Each lot of our GMP-premium antibodies comes with the electronic Certificate of Analysis (CoA) that documents the product specifications and Lot-specific information. Full QA review of complete batch record (including bottling and labeling records) is performed prior to product release on the market. CoA is generated as PDF file and sent by email upon request.