Special Focus Issue - Covid-19: Bioanalytical Considerations, Contributions and Lessons – Part 2

Keywords::

• bioanalysis
• COVID-19
• laboratory

It has truly been a pleasure to serve as guest editors for this very important two-part special focus issue of the journal Bioanalysis. The onset of COVID-19 changed nearly every aspect of all of our lives. In so many ways these changes were negative and difficult with lockdowns, social distancing and masking. For millions, it has meant sickness and loss as we havewitnessed millions of deaths across the globe.

As difficult as it has been, we havehad to try to put these challenges aside and continue to live and work in new ways. It is fair to say we haveall had the oddly uncomfortable conversations about the ‘good things’ to come from COVID-19. It just does notfeel right to talk about good things that have happened in the wake of such a global disaster. However, it could also be said that by finding the good, improving, learningand applying those learnings to be better in the future, we are honoring those that suffered most. Not doing so is certainly a mistake. For us as editors and as part of the global scientific community, that is what these two issues are about.

We were excited about the opportunity to highlight the achievement during the pandemic in the context of our chosen field of bioanalysis. These issues have contained amazing scientific developments, new applications of technology to solving COVID-related challenges, and practical insights on different aspects of operating a laboratory during the pandemic. This second part of our special focus issue includes articles that touched on each of these broad areas.

A highlight of this issue is an interview with JW-Smith and SVinter of the UK drug regulatory agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) [1]. They talk about their experience in pivoting to the conduct of remote inspections over the last 2years. Insights are given about the challenges and approaches they have taken to make remote inspections successful and sometimes even advantageous.

Three of the contributions to the journal brought real-world challenges and viewpoints through two commentaries and a conference report. JBriscoe’s commentary on workplace testing for COVID-19 provided insights and a personal perspective on his experiences working with companies to help support their workplace testing needs early in the pandemic when the routine testing, which we now enjoy, was very difficult to find [2]. Coordinated testing efforts allowed employers to start to bring people back to work in critical roles. EGarrafa contributed an interesting commentary on the criticality of making smart treatment decisions based on the right testing approaches employed [3]. The appropriate testing regimes from type of test to even the number of tests has changed over the course of the pandemic. Garrafa discusses these changes and the appropriateness of those changes in such a complex environment. The third article of this edition that highlights current viewpoints related to the pandemic is from PTimmerman in a conference report from the European Bioanalysis Forum Young Scientist Symposium [4]. The attendees at the conference split into small discussion groups where they talked about the negative and positive effects of the pandemic on their research interests.

The articles from JNeat [5] and NPetrovsky [6] focused on topics critical to successful execution of clinical trials conducted for development of new therapeutics and in Petrovsky’s case vaccine trials in particular. Neat provided a real-life example of how his company was able to rapidly implement strict COVID protocols and testing procedures in their clinics and set up testing services in their laboratory in order to restart and keep clinical trials running. It was efforts such as these that were critical to continue the pace of clinical research for COVID treatments and the many therapeutics currently in development for other diseases [5]. Petrovsky’s focus was specifically on the analytical assays used in vaccine development. New tools and assays had to be rapidly developed to meet the requirements of the analytical testing for vaccine development. He outlined state-of-the-art laboratory and in silico approaches to rapidly identify antigen targets, reagent generation and protein characterization so that a wide array of assays could be developed rapidly and effectively [6].

Three articles in the issue were specific to techniques utilized in studying SARS-COV-2 and treatments for COVID-19 utilizing different bioanalytical techniques. AJouyban wrote a review on the application of nanosensors as tools to detect coronaviruses. A total of 27 different nanosensors were highlighted to be in development currently [7]. Due to the pandemic bringing a significantly increased focus on the study of coronaviruses, we can expect significantly more research in the future. Patient-centric clinical trials became a focus of much discussion during the pandemic for both safety and convenience of trial execution. A key part of many of these trials has been patient-centric sampling technologies. JRudge provided a review on the use of one such technology, volumetric absorption microsamplingin COVID-19 clinical research [8]. In the third very exciting submission, SIrvin and colleagues presented their bioanalytical strategy for bioanalysis of an antibody cocktail for treatment of COVID-19 [9]. They were faced with exceptionally tight timelines for measurement of Regeneron’s antibody cocktail treatment and therefore there was notime to generate reagents. Therefore, initial studies were conducted with an LC–MS/MS assay that was able to be developed rapidly without affinity reagents. In order to improve throughput and sensitivity, the assay was subsequently bridged to an MSD electrochemiluminescent immunoassay to complete clinical trials.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.