From the Editor: June 2020

BPI’s June issue always precedes a break in our regular issue schedules in July and August. But summer does not afford us any leisure. This July, we again shall bring you an eBook of summaries from the BPI Theater at the Biotechnology Innovation Organization’s annual convention (this year from digital presentations, which will be available in full on the BPI site) along with our annual Industry Innovators issue. Summer eBook topics will be formulation, exosomes, biosimilars, and expression systems.

BPI’s publication schedule usually doesn’t allow us to highlight pressing news, which is the purview of our BioProcess Insider newsletter. So when we received two timely papers recently, we were delighted to have a chance to share them with you. Both explore current responses to COVID-19 that will have lasting implications.

Abdi Ghaffari et al. delineate the more than 60 companies currently selling or working on coronavirus diagnostic tests and then highlight what challenges remain for those developers. I want BPI to incorporate more diagnostics information going forward to encourage discussions also about combination products and companion diagnostics.
In this month’s “closer,” longtime BPI contributors and current/past editorial advisors from BDO’s BioProcess Technology Consultants team outline key elements of virtual audits. How are virtual walkthroughs and documentation reviews to be managed so that they can satisfy regulatory requirements? This brief discussion is a good place to begin, and we hope to learn more about how you and your companies are approaching auditing tasks in a COVID-19 world.

Because of those timely topics, this issue splits discussion between the planned single-use theme and COVID-19. I always look for connections, real or imagined. My propensity is to identify as many threads as I can and then tug on them to seek out fundamental connections. One such connection between COVID-19 and disposables is that, once the biopharmaceutical industry has approved vaccines and/or immunotherapies, rapid scale-up and distribution will require significant single-use capacity. But is the industry ready for that? Are suppliers and service providers anticipating/preempting the surge? How might different states of quarantine and mitigation influence therapy/vaccine accessibility? How might COVID-19 influence manufacture of current products? What raw-materials supply chains do single-use suppliers rely on, how stable are those networks, and how dependable are overall change-notification procedures? What advice is being given now about multiple sourcing?

Analyzing interconnections during a widespread crisis can cause paralyzing anxiety. But functional interconnections always have driven biopharmaceutical innovation. Those of you who are searching for dependable diagnostics, vaccines, and treatment modalities are feeling tremendous pressure from all sides these days. Never forget that everything you learn during this challenging time ultimately will help to improve human health — and that the world appreciates your efforts.