Market Overview

Ultra-sensitive biological measurements and flexible formats provided by AMMP technology are particularly useful in biological areas requiring high performance and efficient solutions. BioScale’s products have significant performance advantages over existing technologies (Figure 1) that are imprecise, overly complex, time-consuming, and expensive.  BioScale’s platform will have broad applicability to the following markets:

• Biopharmaceuticals
• Life Sciences
• Diagnostics

Figure 1: Platform performance comparison

Biopharmaceuticals

Biopharmaceuticals represent a significant sector in the healthcare industry, exhibiting growth that has outperformed the pharmaceutical market since the year 2000. Biopharmaceuticals are therapeutic biological molecules that are produced in living systems using recombinant DNA technology. They represent the fastest growing class of approved drugs which include cytokines, growth factors, clotting factors, growth hormones, monoclonal antibodies (mAb) and oligonucleotide-based therapeutics. Unlike pharmaceutical small molecules, biotherapeutics are large molecule proteins and peptides that are complex in their development, production and regulation.

The explosive growth in biotherapeutics has caused tremendous demand for ultra-sensitive, easy-to-use, efficient, and robust analytical systems that can provide precise, biologically relevant quantitation during process development, production and pre-clinical phases. BioScale’s goal is to provide solutions for bioprocessing that are ultra-sensitive and compatible with complex matrices typically found in the following applications:

• Routine detection of process impurities as required by FDA
• Clinical immunogenicity monitoring: ADA and neutralizing antibodies
• Pre-clinical market: animal testing, ADME-tox, etc.

Life Sciences

In the life sciences, researchers require assays that deliver robust interrogation of biological systems rapidly and with high sensitivity, reproducibility and levels of quantitation across a range of different analytes and sample types. The limitations of current platforms result in tradeoffs between cost, data quality, reproducibility, time to results and ease of use. BioScale products can replace or supplement ELISA, bead-based and electrochemiluminescence-based technologies in many applications. For instance, BioScale products are ideally suited for biomarker research.

Diagnostics

Rising health-care costs are changing the face of diagnostic testing away from centralized laboratory testing towards outpatient or ambulatory testing that requires rapid testing and treatment for immediate clinical outcomes and economic benefits.  This has been a key driving factor in point-of-care testing that is accessible in physician office labs (POLs), urgent care and other outpatient settings. Point-of-care testing is thus experiencing double-digit growth in response to the growing need for better patient care by improving turnaround time to results, cost containment, an aging population, and increased incidence of certain diseases. In addition, the explosion of world health concerns has also fueled the need for POC testing for the treatment and diagnosis of infectious diseases in developing countries.

There is industry pressure for manufacturers to develop diagnostics instruments and tests that are simple and easy to use for POC testing in distributed settings. The diagnostics platforms of today lack a solution that delivers the data quality of centralized laboratories in a point of care format. BioScale’s capabilities add value in clinical applications with:

• Biomarker identification, validation, and application through sensitively and quantitatively measuring proteins and protein panels’
• Enabling syndrome-based diagnostics through heterogeneous analyte detection’
• Rapid delivery of central lab-quality results with an easy-to-use, deployable system’