Testimonials

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University of Washington: Characterization of β-amyloid oligomers

Valerie Daggett, Professor of Bioengineering (primary), Biochemistry, Biomedical and Health Informatics, Chemical Engineering, Molecular Engineering, Neuroscience, and Biological Physics, Structure and Design

Having deployed MMS alongside circular dichroism, FTIR and NMR for non-standard secondary structure analysis of β-amyloid oligomers in Alzheimer’s Disease, I am confident in the applications for the technology. We believe it can play a significant role in the protein characterization technology toolkit, overcoming shortcomings in existing techniques. In our case the quality of the results obtained, the small sample volumes, the ability to quickly probe low concentrations of amyloid proteins in solution under ‘physiological’ conditions. While there are many other interesting and important applications of this technology, RedShift Bioanalytics’ MMS platform fills a void in the amyloid field that is helping to shed light on the fundamental conformational changes associated with disease. 

I believe that this product’s ability to provide protein and peptide structural data not previously possible, will have a significant impact on the development of biotherapeutics, and in the fight against diseases such as Alzheimer’s Disease.

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Associate Director, Analytical and Pharmaceutical Development & Principal Development Associate, Analytical and Pharmaceutical Development

Protein characterization is a crucial part of the overall quality control strategy for biopharmaceutical drugs which includes an understanding of the product attributes. The company is developing antibody-drug conjugates (ADC) for cancer treatments. We are heavily reliant on protein characterization to help us observe and understand the changes in MAb structure that occur during the ADC manufacturing process. Foremost among the changes that are observed are increases in hydrophobicity following conjugation, potential impacts on long-term stability and whether the higher-order structure (HOS) is modified in some way that affects the stability.

We use many analytical techniques to look at ADC stability during formulation development. Many of the techniques are time consuming, require a significant amount of sample and are not sensitive enough to detect the relatively small changes in structure which happen during ADC manufacture. This is why we believe the AQS3pro will have such an impact.

MMS is really relevant to establishing product comparability. Changes in manufacturing process or manufacturing site can have a significant impact on product quality and therefore comparability. Since changes in HOS may be related to changes in product quality (e.g. potency) it is vital to have analytical methods which are sensitive, automated and relatively high throughput for detecting these changes. MMS is one of the newer techniques that we have found that meets these requirements. Going forward MMS will be very useful for comparability assessments of products as they proceed further in clinical and commercial development.

We believe that the instrument RedShiftBio has developed will have a positive impact on the process of developing biopharmaceuticals for the foreseeable future.