BIO SB

Bio SB is a biotechnology company with core competencies in research and development of immunological and molecular biological in vitro products for diagnostics. Biomedical laboratories are equipped with their instruments to improve diagnosis, monitoring of disease progression and therapy prediction and prognosis.

Quality

A variety of products with outstanding certified quality are available from Bio SB. The company is CE/IVDD and ISO 13485:2016 certified. All products are also manufactured and developed in accordance with the Diagnostic Directive 98/79/EC and the guidelines of the US Food and Drug Administration (FDA), which describes the requirements for quality management systems in 21 CFR Part 820 cGMP. 21 CFR Part 820 is the equivalent of ISO 13485. The in vitro products comply with the highest standard. The entire Bio SB team is trained in the quality system.

Immunohistochemistry

Immunohistochemistry (IHC) is based on an antibody-antigen reaction. The binding of the antibody to an antigen (protein, structures in tissue, etc.) can be visualized by conjugating the antibodies with a reporter molecule. Various molecules such as enzymes and fluorochromes are available as reporter molecules.

In medical histology, this method is widely used to identify and classify tumor cells expressing specific antigens from blood smears, cell preparations, or tissue sections

Enzyme immunohistochemistry uses an enzyme as a reporter molecule that converts the chromogen into a colored insoluble end product. Often a peroxidase is used in this system for example horseradish peroxidase (HRP). HRP converts the reduced colorless chromogen, e.g. diaminobenzidine (DBA), into a colored (here: brown) insoluble end product in the presence of hydrogen peroxide. The colored end product is now oxidized.

A distinction is made between the direct (one-step) and indirect (two-step) methods. In the one-step method, the labeled antibody binds directly to the antigen. In the two-stage method, a primary antibody binds to the antigen first. In the second step, the labeled secondary antibody, which is specifically directed against the primary antibody, then binds and converts the chromogen to the colored end product.

Products

Bio SB develops and produces rabbit and mouse monoclonal (IVD) antibodies used in immunohistochemistry diagnostics.

The immunochemicals, in situ hybridization technologies (CISH, FISH) & nucleic acids represent important products for research in microbiology, immunology, pathology and therapy and cancer research and diagnostics. With a wide range of in-house developed highly sensitive and unique detection systems for immunohistochemistry (IHC), immunocytochemistry (ICC) and immunofluorescence (IF), Bio SB is broadly positioned and already internationally represented with the brands ImmunoDetector, PolyDetector, PolyDetector Plus and TintoFast Mohs PolyDetector systems.

For automation of IHC, ICC and IF protocols, the company has the Bio SB TintoStainer. It is an automated system for use in laboratories that need to implement a variety of protocols while maintaining low cost of ownership.

Chromogenic in situ hybridization (CISH) and fluorescent in situ hybridization (FISH) are technologies of interest for the evaluation and detection of genetic aberrations such as translocations, deletions, amplifications, chromosomal aneuploidy and gene amplifications. Furthermore, rapid detection and discrimination of human pathogenic viruses in various sample materials such as tissue sections, smears or blood are available.

The Mohs IHC antibody systems

Bio SB has developed four in vitro diagnostic systems for Mohs surgery specimens to enable rapid and easy identification and classification of tumor cells.

The Bio SB Polydetector is 1-step system, which is based on a Fab micropolymer scaffold. The scaffold is conjugated with anti-mouse and anti-rabbit Fab Ig's and HRP enzymes. The Fc region of the corresponding immunoglobulins was removed to reduce non-specific reaction. It can be applied to antigens in formalin-fixed, paraffin-embedded tissues, cryostat sections, blood smears, tissue smears and cell preparations.

The Mohs Mouse/Rabbit PolyDetector DAB HRP Brown Detection System, without biotin, provides specific immunodetection for all types of nuclear, cytoplasmic and membranous antigens in various types of frozen, FFPE tissues and cell preparations. The system is suitable for use with monoclonal and polyclonal mouse IgG and IgM and rabbit primary antibodies, and the Bio SB antibodies are optimized accordingly for this application. However, since this system is a universal kit, it can also work with antibodies from other manufacturers, provided that appropriate optimization is available. Included are an anti-mouse/rabbit horseradish peroxidase microbiopolymer solution, an HRP Brown buffer substrate and an HRP Brown chromogen solution.

The Mohs Mouse/Rabbit PolyDetector Plus DAB HRP Brown Detection System is a 2-stage Fab micropolymer detection system without biotin. It also contains an anti-mouse/rabbit horseradish peroxidase micropolymer compound and label, a DAB buffer substrate and a DAB chromogen solution.

The Mohs Mouse/Rabbit PolyDetector HRP Green Detection System, unlike the Brown system, contains a green chromogen; other than that, it is comparable. The same applies to the Mohs Mouse/Rabbit PolyDetector Plus DAB HRP Green Detection System.

Reach

Bio SB has a strong network of distributors worldwide, supporting the scientific and medical activities of clinicians, pathologists and researchers.

Environmental Management Program

Bio SB is committed to being an environmentally conscious company. Meeting legal requirements, creating environmental awareness among employees, and adjusting business strategies accordingly are goals to advance environmental protection. The prevention of environmental pollution, as well as the reduction of waste and the minimization of resource and energy consumption are given high priority.

We are very happy to have a successful cooperation and to be a part of the Bio SB network!