SingleFlowEx Premium Antibodies - Always look on the bright side of Flow

   
   

EXBIO has developed a broad portfolio of single-color antibodies for flow cytometry (use in Clinical Research and Laboratory Developed Tests, now offered under our trademark SingleFlowEx.

SingleFlowEx reagents are specifically designed for use in 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).

 

Premium Antibodies (GMP)

Contract Research Organizations (CRO)/Pharma Industry and Clinical laboratories/Health Care providers require a high degree of quality assurance for 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 ISO 13485-certified manufacturing site, also registered as medical device Manufacturer with FDA.

Product Design

The design and development of SingleFlowEx reagents is conducted in defined steps. 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).

Lot-to-Lot Consistency and Reproducibility in performance

In order to produce accurate and reproducible results, laboratories require reagents that maintain their performance characteristics with minimum lot-to-lot variability and stable 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 (specificity staining patterns, MFI intensities and stain index by flow cytometry). New lots are always tested against previous (reference) lots to control for degree of variability.

Difference between Premium antibodies (GMP) and traditional research-use versions

Customers using our traditional research use only (RUO) reagents for their flow cytometry assays often ask what is so different with the SingleFlowEx reagents and what are the reasons to use preferentially the SingleFlowEx reagents for building their multicolor panels. Indeed, hybridoma cell line, fluorochrome material, and the basic working instructions/ manufacturing procedures for Premium antibodies (GMP) and traditional RUO reagents are the similar, as well as their application in flow cytometry.

It is the GMP regulation which makes the difference. Compared to traditional RUO products, SingleFlowEx reagents come with extensive documentation for traceability as well as stringent quality control testing. Full quality assurance (QA) review of the complete batch record (including bottling and labeling records) is performed prior to product release to the market. SingleFlowEx reagents therefore meet the essential safety and performance requirements to facilitate use in laboratory developed tests by accredited healthcare institutions in accordance with EU regulation (2017/746) on in-vitro medical devices (IVDR).