From The Stage

Supporting Biosimilar Assessment: Best Practices for the Development and Validation of Neutralizing Antibody Assays

Dr. Dominique Gouty
Posted by Dr. Dominique Gouty / / Biosimilars, Immunogenicity

Immunogenicity assessments are a critical component to determining the comparability of an originator drug and a biosimilar. It is necessary to determine both neutralizing and non-neutralizing antibody incidence for an originator drug and a biosimilar, and understand the immunogenicity’s impact on PK results as well as its association with adverse events.

Strategic Bioanalytical Partnerships for the Win-Win-Win

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Cell-Based Assays, CRO Selection

For bioanalytical CROs, it is of critical importance to build an internal team capable of meeting their pharmaceutical and biotech customers’ drug development goals. However, many overlook the benefits of strategically aligning with external partners – those organizations that can add value to the CRO’s offerings, supplementing their solutions and services to make them more comprehensive and attractive to customers.

BioAgilytix Team Q&A: Meet Matt Bray, Scientist and Bioanalytical Project Manager

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, CRO Selection

To gain a better understanding of how BioAgilytix delivers its premium bioanalytical services, it is important to know the people that drive our science. In this Q&A session, we get to know Matt Bray, Scientist/Bioanalytical Project Manager (BPM) at BioAgilytix, and how he has grown with the company since starting as our very first analyst nearly 8 years ago.

Evaluating the Immunogenicity of Antibody-Drug Conjugates

Dr. Corinna Fiorotti
Posted by Dr. Corinna Fiorotti / / Cell-Based Assays, Immunogenicity

Antibody–drug conjugates (ADCs) represent an innovative therapeutic approach that provides novel treatment options and hope for patients with cancer and infectious disease. In fact, ADCs are quickly becoming one of the fastest growing classes of oncology therapeutics in the pipelines of many pharmaceutical companies. The design behind ADC-based treatments – leveraging the specificity of a monoclonal antibody (mAb) to deliver a potent small-molecule cytotoxic drug to the intended pharmacological target while reducing the exposure of normal cells – seems relatively simple conceptually. However, ADCs have presented more challenges than developers…

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

There is a lot of confusion in the world of biomarker testing when it comes to the terms “assay qualification” and “assay validation”. These two terms are not strictly defined and are even used interchangeably at times. This confusion stems from the diverse scientific backgrounds and disciplines of those of us working in the biomarker field. Scientists from a manufacturing setting, clinical setting, or research setting have a somewhat different understanding of these two terms. Conversely, there is a clear distinction between “qualification” and “validation” for those working in analytical…

Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Uncategorized

I recently had the opportunity to work with a multicentric group of experts in immune profiling and immunogenic responses on the creation of a scientific peer-reviewed paper titled, “Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling”. The paper, originally published in the European Journal of Allergy and Clinical Immunology in June of 2017, examines different α-Gal-containing analytes in singleplex and multiplex assays to resolve individual sensitization patterns with IgE against α-Gal. Glycoproteins and glycolipids of some mammalian species contain the disaccharide galactosyl-α-(1,3)-galactose (α-Gal), but it…

The Scientific Topics that Shaped Our 2017

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, Industry Update

Throughout 2017, BioAgilytix scientists continued to establish themselves as thought leaders in the industry through the publication of blogs and industry articles, covering topics from biomarkers and immunogenicity to investing in bioanalytical technology. We thank you for engaging with our posts this year, and we look forward to sharing more about our rapidly changing industry with you in 2018. Take a look back at some of 2017’s hot topics in bioanalysis through some of our favorite content pieces: 1. Immuno-oncology: Advancing Innovative Therapeutic Options for Treating Human Cancers Learn more…

Modern Challenges of Single and Multiplex Biomarker Validation

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Biomarkers, Industry Update

Biomarker validation can be confusing. We constantly hear about qualification versus validation, fit-for-purpose validation, and context of use. Due to the ‘grey area’ nature of biomarker work, many companies interpret these concepts and approaches differently. As scientists working on biomarker projects, we have to deal with a lot of variability between reagent and kit lots, high or low biomarker endogenous levels, and how to precisely assess antibody specificity in commercial kits, among other things. In a perfect world, we would have decisive guidance on how to manage all of these…

BioAgilytix Team Q&A: Meet Jiewu Liu, Manager I/Bioanalytical Project Manager

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, CRO Selection

BioAgilytix is dedicated to being a true partner in our customers’ increasingly complex large molecule studies, and our scientific staff is a key driver in making this possible. Producing the best results requires the best people and when you look closer, it is easy to see how our employees’ deep expertise makes BioAgilytix work. We sat down and talked with members of the Scientific, Quality Assurance (QA), and Quality Control (QC) teams to help you learn more about how they contribute to our success. In the fourth and final Q&A…