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COVID-19: Knowledge Hub
The COVID-19 pandemic has affected the entire world, not least of which the pharmaceutical industry.
In Albumedix, we are proud to support multiple customers active in the fight against the Coronavirus, developing and delivering medical devices, diagnostics or vaccines which will help patients worldwide. With this responsibility comes a need of paramount importance for our in-house experts to have a constant grip on the evolving medical landscape surrounding COVID-19; with respect to development as well as challenges.
Albumedix gathered our frequently asked questions & pitched them to our thought leaders, including our Chief Technology Officer, Director of Regulatory Affairs and Business Development Director covering Europe.
The 3-part series is available to view below, as well as on our AX-TV YouTube Channel.
- Recombumin® for Medical Devices
- Recombumin® for Vaccine Stabilization
- Recombumin® for Improving Diagnostics
Technical insights from Phil Morton, CTO
We are joined by our Chief Technology Officer, Phil Morton, to discuss the technical challenges that need consideration when developing a COVID-19 vaccine. In our discussion, Phil draws on his own experience in the biopharmaceutical industry spanning more than 25 years, as well as insights based on years of technical customer support and application data development.
This episode covers everything from the characterization of the SARS-CoV2 virus, to the differences between the various types of vaccines, to specific manufacturing challenges in vaccine development. Phil addresses live-attenuated vaccines, inactivated vaccines, subunit vaccines, virus-like particles and gene-based vaccines.
Finally, Phil dives into how the stability issues of these vaccines may be addressed using recombinant human albumin.
Regulatory perspectives from Harriet Edwards, Director of Regulatory Affairs
Harriet Edwards, Director of Regulatory Affairs in Albumedix, is responsible for regulatory filings of Albumedix' products as well as the extensive regulatory customer support we provide alongside our product sales. In the following episode, Harriet discusses the traditional clinical stages of vaccine development and the regulatory requirements throughout the process. The development process of the COVID-19 vaccines have been far from traditional in their timelines, so Harriet also delves into how this has been handled from a regulatory perspective and the challenges the industry and regulators have faced.
Finally, Harriet adds her perspective on how this year has affected the future of regulations.
Commercial outlook by Joanna Hay, Business Development Director
As Business Development Director in Europe, Joanna Hay spends every day in Albumedix helping customers with their questions, understanding the challenges they are facing and the industry in which they operate. This year has been no exception and with new types of vaccines reaching patients and the speed in which they are being developed, manufactured and distributed challenges and urgent needs to find solutions are especially critical.
Joanna reviews the landscape of COVID-19 vaccines in development and reflects on what this tells us about market trends and the future of vaccine developments.
Finally, Joanna reviews the challenges faced by these vaccines especially focusing on the more novel gene-based vaccines.
To wrap up our COVID-19 focused AX-TV series, we asked our 3 in-house experts how they think this pandemic will affect the future of vaccine development. The Albumedix Director of Regulatory Affairs, Chief Technology Officer and European Business Development Director share their thoughts, and further to this, consider the most exciting treatment trend or innovation in the vaccine development space in general.