Editor highlights: AAPS PharmSci360

With the COVID-19 pandemic continuing to affect in-person events and conferences, the organizing committee of AAPS PharmSci360 (26 October–5 November 2020) converted the meeting to a fully virtual platform, featuring a six-track scientific program. The online conference featured hundreds of symposia, speakers and posters. In this round-up, we summarize some of our highlights from attending the virtual conference.

COVID-19 trials: strategies to ensure success

It is not a surprise that COVID-19 featured heavily within the agenda of AAPS PharmSci360. The session focusing on COVID-19 trials discussed the importance of protocol design and effective patient engagement. Palanikumar Manoharan and Catherine Vrentas (both PPD; VA, USA) listed the current vaccine trials being undertaken by Pfizer (NY, USA) and BioNTech (Mainz, Germany), AstraZeneca (Cambridge, UK) and the University of Oxford (UK) and Moderna (MA, USA). They also explained the unprecedented speed of these clinical trials taking 9–10 months from start to Phase II and III trials. The bioanalytical perspective was also discussed as the development and validation of methodologies is vital when used to analyse patient samples; for example, the development of molecular tests, serological test and immunogenicity testing.

Boldly going where no LC–MS assay has gone before

How well is LC–MS doing in supporting regulated bioanalysis? This question was explored in this session as LC–MS is widely adopted as the gold standard for small molecule drug (PK) quantitation as it is adaptable and easy to use. Steve Lowes (QPS; NY, USA) explained the dramatic improvements in the capabilities of LC–MS including sensitivity and practical resolution in terms of mass and chromatographic separations. It is true that LC–MS remains a critical tool of the modern bioanalyst. Lowes described the Achilles heel of LC–MS assays, which is how serial LC separations still take minutes per sample and the challenge of matrix effects. We need to leverage machine learning to increase the throughput of our bioanalytical labs to increase capacity and capability. Particularly highlighted by lessons learnt from COVID-19, automation and speed are critical, however, creating fit-for-purpose approaches should always be the priority.

Extending flow cytometry sample stability for regulatory T-cells

Flow cytometry is a technique that has the capability to measure multiple characteristics of single cells, for example, the relative surface area or size, internal complexity and cell populations. In this talk, Amanda Hayes (PRA Health Sciences; KS, USA) discussed how sample stability is a challenge in flow cytometry, especially with rare cell markers such as Tregs. Hayes discussed the advantages that can be gained when using a method to extend stability of flow cytometry samples, which include improving data quality, increased cost-effectiveness and the ability for sample reanalysis. Read more in our Peek Behind the Paper>>

A look into the future of the LC–MS bioanalytical laboratory

A key theme of this session was new modalities and how they lead to more unknowns. There is an increased number of questions to answer during drug development and an increased variety of assays required to support that development. In this session, Stephanie Pasas-Farmer (Ariadne Solutions; KS, USA) explained how the industry is looking towards new technologies to help answer these questions, for example ddPCR. Pasas-Farmer further explained the gaps in regulations, which can have an impact on global submissions and applications. The bioanalytical regulatory guidance generally focuses on traditional approaches with current regulation gaps in flow cytometry, hybrid assays and ddPCR. The lack of harmonization leads to the lack of consistency of assay requirements and parameters, data quality and risk of erroneous data. Pasas-Farmer concluded remarking that “new technology will drive innovation – and we will need to do more with less.” In the future there will be a decrease in manual process to improve quality and she highlighted how remote access cannot compromise security. Two key future trends included the use of hybrid assays for large molecule analysis, as you combine the advantages of LBA and LC–MS/MS, and microsampling, which enables simplified collection, is minimally evasive and is applicable for challenging populations.

Are you ready for the laboratory of the future?

In the past few decades, biotherapeutics have become a significant part of modern medicine. Bioanalytical assays are needed to support drug development and inform on the safety and efficacy of the candidate. Traditionally LBAs have been used to quantify the concentration of drug candidates in biological fluid. LC–MS has emerged as another viable option for the quantification of biotherapeutics. In this session Faye Vazvaei (Merck; PA, USA) explained the different bioanalytical strategies for using mass spectrometry:

  • Top-down or intact analysis – this is a direct measurement as it preserves the structure but lacks sensitivity
  • Bottom-up or analysis using a surrogate peptide (most popular) – this is by far the most common method of PK as it is sensitive, but structural information is lost
  • Middle-down – analysis of subunits – this somewhat preserves the structure and is more sensitive than intact

Despite the coronavirus pandemic, it was a pleasure to still be able to attend the conference virtually, as it highlighted the importance of continuing to share knowledge and collaborate globally.