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An author’s perspective: Maria Myzithras on optimizing NBE PK/PD assays

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To help provide insight into the recent article published in Bioanalysis: Optimizing NBE PK/PD assays using the Gyrolab Affinity Software; conveniently within the bioanalyst’s existing workflow, we spoke with author Maria Myzithras, bioanalytical Research Scientist IV in the NBE PK Group in the Biotherapeutics Discovery department at Boehringer Ingelheim (CT, USA). Maria explains why she felt this was an important area for bioanalysis and worthy of publication. Maria has been working in this field of bioanalysis for 6 years.

Maria Myzithras 150x150“I am currently a bioanalytical Research Scientist IV in the NBE PK Group in the Biotherapeutics Discovery department at Boehringer Ingelheim (CT, USA). I earned my BS in Molecular and Cellular Biology and MS in Applied Genomics from the University of Connecticut (CT, USA). I previously worked in the field of molecular biology at a small start-up in Branford (CT, USA) that was later acquired by Illumina, Inc. (CA, USA).

I joined Boehringer Ingelheim in 2012 and jumped right into bioanalysis of large molecules from animal studies in a pre-clinical research setting, supporting multiple therapeutic indications from research sites across the globe. Over the years, our group has developed countless custom assays to detect monoclonal antibodies and custom formatted protein-based molecules in multiple species, along with ADA titer detection and corresponding target engagement and biomarker assays. Our core fundamental platforms include ELISA and MSD for bioanalytical assay development and sample analysis but we have acquired multiple technologies to aid in new techniques and expand our capabilities. For example, we have implemented the Simoa by Quanterix (MA, USA) for sensitivity improvements, the Gyrolab xP workstation for high-throughput analysis of mouse samples to enable microsampling and Luminex (TX, USA) capabilities for multiplexing biomarker detection.”

1. What inspired you to work in this field of bioanalysis?
I wanted to work in the pharmaceutical industry, and in a research-based setting, so I could have an impact on new ideas early in the drug discovery process. An exciting opportunity in the bioanalytical field at Boehringer Ingelheim was presented during my career and I was interested in the early profiling of novel antibodies and projects from multiple therapeutic indications including cardiovascular, immunology, respiratory and cancer. The field is exciting as we are constantly developing custom assays tailored to the goals of each specific project, and characterizing novel antibody therapeutics in pharmacokinetic studies and pharmacology models. The field is growing rapidly, with new protein therapeutic modalities, so the thought process is always exciting and developing assays is always a new learning experience. The data we generate can also be used for early human dose feasibility assessments, so we are involved in critical decisions made downstream and into clinical development.

2. What impact would you like to see/expect to see as a result of your publication?
I hope that fellow bioanalytical scientists can gain perspective on the challenges of target and biomarker detection, and how they can achieve additional critical information in a seamless process using the Gyrolab Affinity Software. The instrument is widely used in bioanalytical settings, and scientists can add value with the additional capability to determine KD values in a similar workflow commonly used for assay development. Typically during assay development, especially for target detection, the bioanalyst is screening multiple reagents, in an attempt to identify best pairs, and information could be lacking if they are purchased from different vendors. This is a good tool to help this process without extending timelines or relying on reagent characterization groups. Also, I hope the publication is utilized by scientists in other functions in the drug discovery pipeline who could benefit from integrating the high-throughput and miniaturized binding affinity determinations, as enabled by the Gyrolab.

My publication might increase a bioanalyst’s confidence to enable a new technology development evaluation for their workflow, since KD values were within variability compared to traditional SPR methods.

3. What are the next steps for your research and this field of bioanalysis?
The next steps are to continue expanding on developing assays for the reliable detection of different analyte species; whether free and total drug, or free and total target, to support advancements of projects. With new technologies, we are pushing limits not just with species detected, but also with sensitivity and throughput. We will continue to build as drug modalities, concept and targets continue to become increasingly complicated and difficult to target, and to also use this information to support additional PK/PD modelling. We will continue to find ways to increase efficiencies and capabilities by using existing technologies as well – the Gyrolab affinity software being a prime example.

4. Do you have any advice for anyone who may be interested in working in this field?
My advice is that the field is challenging but rewarding since you are involved in a critical area in the early drug development process. The field keeps evolving, with new technologies and techniques being developed, so there are endless opportunities to learn and grow as a scientist in an exciting and fast-paced career field.

Reference: Myzithras M, Bigwarfe T, Waltz E, Li H, Ahlberg J, Rybina I et al. Optimizing NBE PK/PD assays using the Gyrolab Affinity Software; conveniently within the bioanalyst’s existing workflow. Bioanalysis. 10(6) 397–406 (2018)

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