Alfonso-aaa-IntroductionAt Bio SB our passion is providing biomedical laboratories with the tools to improve the diagnosis, prognosis and therapies that benefit patients worldwide.

Bio SB is proud to develop, manufacture and distribute unique products for Immunohistochemistry, FISH, CISH and PCR technologies that meet the highest International standards for applications in Molecular Pathology. With a network of over 45 distributors that represent Bio SB in the Americas, Europe, Africa, Asia, Australia and the Middle East, Bio SB can ensure that our products can reach pathologists, researchers, and patients worldwide.

Bio SB has a talented, dedicated, and vibrant team of professionals that excel in the R&D, Production and Marketing of Nucleic Acids & Immunochemicals for Cancer Research, Microbiology, Immunology and Genetics. Bio SB is a CE/IVDD and ISO 13485:2016 certified company that manufactures and develops products in accordance with USA FDA QSR 21 CFR Part 820 cGMP. These guidelines enable us to produce an IVD product that meets the highest in vitro diagnostic standards.

Our mission is to develop and supply high-quality Nucleic Acids & Immunochemicals while providing outstanding technical service to our customers. We develop rabbit and mouse monoclonal antibodies and detection systems for Immunohistochemistry and Immunocytochemistry using proprietary technologies. Our ImmunoDetector, PolyDetector, and PolyDetector Plus systems are unique, high-sensitivity detection systems already in use in laboratories worldwide.

We are very proud to announce our collaboration with ThermoFisher to provide the TintoStainer for Anatomic Pathology. The addition of the TintoStainer enables Bio SB to offer the most reliable, flexible, and open automated system for use in Immunohistochemistry and Immunocytochemistry (IHC & ICC). The Bio SB TintoStainer is an automated system for use in laboratories that need to implement a wide variety of IHC and ICC protocols, yet need to maintain low operating costs. The Bio SB TintoStainer is a rapid, flexible, open and affordable solution which allows for fast implementation of laboratory protocols.

Bio SB has also partnered with Epitomics of Burlingame, CA to supply our customers with a line of innovative, sensitive, specific, and cost effective IVD Rabbit Monoclonal Antibodies to help laboratories worldwide improve patient care. This partnership allows Bio SB to have one of the largest selections of Rabbit Monoclonal antibodies for use in Anatomic Pathology.

Our strategic alliance with ZytoVision of Germany has added a complete range of products for chromogenic (CISH) and florescent in situ hybridization (FISH). These technologies are designed for the evaluation and detection of genetic aberrations such as translocations, deletions, amplifications, chromosomal aneuploidy and gene amplifications. We also offer outstanding fast detection and discrimination of human pathogenic viruses in formalin-fixed, paraffin-embedded tissue sections, cell samples, blood or bone marrow smears, and metaphase chromosome spreads.

As industry research, genetic sequencing, and explosive growth in genomics pushes molecular pathology forward, Bio SB will continue to offer a large portfolio of products at a competitive price to laboratories, researchers, clinicians, and patients worldwide.

Dr. Alfonso Heras

President & CEO

Quality Policy Statement

At Bio SB quality, customer satisfaction, and innovation are our highest priorities.
We develop, manufacture, market, and distribute unique products for
Immunohistochemistry (IHC), Immunocytochemistry (ICC), Fluorescent in situ hybridization (FISH), and Chromogenic in situ hybridization (CISH) that are used for applications in Molecular Pathology, Cancer Research, Microbiology, Immunopathology, Immunology and Genetics. We strive to provide our customers with the tools to improve the diagnosis, prognosis and therapies that benefit patients worldwide.

Our products meet the highest national and international regulatory in-vitro diagnostic standards in accordance with FDA QSR 21 CFR Part 820 cGMP, ISO 13485:2016, and In-Vitro Diagnostic Directive 98/79/EC.

We are committed to meet and exceed our customers’ expectations and requirements to deliver excellence through our products, services and relationships. We will accomplish this through seeking continuous improvement of our core processes to ensure the safety and effectiveness of our products.

To this end we will maintain and improve the effectiveness of our quality management systems company-wide by continually pursuing and reviewing measurable quality objectives related to:
• Product development and improvement
• Quality management system planning and improvement
• Risk management
• Supplier quality assurance and monitoring
• Personnel training and competency assessment
• Regulatory compliance
• Customer satisfaction
Our priority is to ensure that all team members understand their responsibility to provide the highest quality products to our customers and ultimately to the patient. All Bio SB team members are trained on our Quality System and are expected to perform their duties in accordance with the quality objectives applicable to their work.

Alfonso Heras
President and CEO

Bio SB Environmental Management Program

Bio SB Inc. is committed to be an environmentally responsible In-Vitro
Diagnostic company and strives to minimize environmental impacts concerning its activities, products and services. To that end we shall:

• Comply with applicable legal requirements relating to
environmental aspects
• Include consideration of environmental issues in our business
strategies
• Promote environmental awareness and ensure that protection of the
environment is part of our company culture
• Aim to prevent pollution, reduce waste, and minimize consumption
of resources and energy
• Encourage environmental protection among suppliers
Bio SB applies continuous improvement measures to its environmental
management program. This policy will be communicated to all staff. Santa Barbara, August 1, 2018

Dr. Alfonso Heras
President and CEO