B2S Life Sciences is a biotherapeutic enablement company advancing improved analytical methods and outcomes for companies involved in the development of biotherapeutic drugs and diagnostics. Our mission is to leverage extensive expertise in bioanalytical methods development and statistical analysis to provide superior custom reagent products and services that are tailored to our clients’ needs, and to manage these products and services for clients throughout the drug development process. As a result, our combination of expertise, products, and services thereby uniquely qualifies us to better the development process for biotherapeutic drugs and diagnostics.
I. Bioanalytical strategies
II. Assay Development & Validation
III. Exploratory Data Analysis & Mining
IV. BioMarker Reference Standard Generation & Characterization
We have been at the forefront of the development of scientifically based method validation. As co-authors on many of the currently cited “white papers,” we understand validation is not just “checking boxes” but an integral part of assessment and application of methods. Our ultimate goal is to make the bioanalytical sections of submission a non-issue and to allow regulators to focus on safety and efficacy data.
Unlike many bioanalytical consultants, our primary expertise is in the development, validation and application of ligand binding assays. With our combined experience (well over 100 years), there are few issues we have not seen before. We not only have experience with various technologies, we likely were participants in developing the techniques. As such, we know the strengths and weaknesses of each technology and can therefore help you pick the right technology based on your projects needs as well as where the assays will be performed.
With over three decades of experience in the successful implementation of discovery research, our team offers the following services in a broad range of drug discovery areas, including assays for drug screening, genomics, cell culture, gene transfer/gene therapy, physiology, and pharmacology.
Experimental Design & Implementation of Studies—We will help you design and carry out your research in any of the above areas. We will first discuss your research ideas with you and will work with you to develop an optimal plan of implementation. This includes developing one or more of the following strategies prior to starting the actual research:
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