Andson Biotech has developed a suite of technologies that accelerate critical biochemical measurements which are critical for modern drug development and manufacturing. Our flagship microfluidic-based platform, the DynaChip, attaches to workhorse biopharma analytical/QC tools known as mass spectrometers to enable simple and accurate analytics in just minutes instead of the standard hours-to-days. We are developing our technology alongside a broad spectrum of biopharma stakeholders including leading cell-and-gene therapy companies, world-class CDMOs and even physician scientists developing new types of cell-therapies. We are working with these early adopters to develop our platform for three reasons: 1) To accelerate and simplify "common" analytical measurements carried out by mass spectrometrists all over the world 2) To develop better, faster assays to get advanced therapies to market faster 3) To provide predictive process control for reduced in-process failures of complex and costly biopharma processes
What is the problem?
Modern therapeutics are providing lasting cures to cancer and reversing the course of terminal genetic disorders. There are thousands of these advanced therapies in the pipeline, ranging from biologics and hybrid therapies to cellular immunotherapies and in vivo genetic therapies. Unfortunately, the few FDA approved advanced therapies are incredibly costly ($0.5-2 MM per patient), prone to batch failure, and widely inaccessible. While science and medicine have advanced significantly in the last decade, scaling modern biotherapies from lab-to-market remains a challenge. 88% of the drugs in the FDA pipeline will fail to reach final approval, and over 50% of these rejections will be related directly to issues with drug manufacturing and quality control. Andson Biotech is first providing next generation analytics to meet the needs of modern biopharma. Our technologies enable fast and simple analytics that are used to accelerate drug development and provide better methods of quality control for modern drugs.
What is their solution?
The FDA demands that pharmaceutical companies develop extensive manufacturing monitoring and control techniques to ensure the drugs they deliver are safe and efficacious. Unfortunately, there is a void in adequate analytical technologies for the most complex biopharma processes. Existing analytical methods do not accurately capture the dynamic nature of complex biopharma processes which has led to a ripple effect of high batch-failure rates for approved therapies and significant regulatory delays for therapies still in the FDA pipeline. Andson Biotech has developed a simple and fast approach to get detailed analytics needed for modern biopharmaceuticals. Our DynaChip technology attaches directly to analytical tools known as mass spectrometers and drastically accelerates the workflow for results on demand, in just minutes, instead of the traditional hours to days. Critically, our platform can gather in-process data for deeper insights to the manufacturing process to enable predictive feedback control.
