The Post-COVID-19 State of Biomanufacturing News from the Biotech Start-up Symposium

by Simon Agwale and Thomas Ransohoff | January 18, 2022

During last month’s Biotech Start-up Symposium, attendees heard an all-star team of experts discuss the intricacies of raising venture capital and a variety of other relevant topics. But no matter the discussion a single topic kept emerging–COVID-19.

Of all the industries affected by the pandemic, perhaps none was impacted more than biotech and pharma. During the symposium it became clear that some good news has actually come out of the pandemic. Inefficiencies within the industry were finally exposed and repaired, so the next time a new virus comes along we will be better prepared to tackle it.

According to Thomas Ransohoff of Resilience, “The pandemic revealed two fundamental needs; first, that the resilience of domestic supply chains is crucial to health and economic security and secondly, that our ability to produce the complex medicines of the future at full scale is critical to our ability to deliver the benefits of these medicines.”

The manufacturing and deployment of the Pfizer and Moderna vaccines vindicated the second of Mr. Ransohoff’s points, as exemplified by two messenger RNA vaccines developed in record time despite not having been cleared for use in humans before. As of this writing over 8 billion doses have been administered worldwide and nearly 60% of the world population has received at least one dose¹. A testament to our ingenuity and scalability.

During the symposium, Mr. Ransohoff also shared his thoughts on innovation in biomanufacturing. He says the introduction of new technologies is possible but still challenging, highlighting the need for companies such as Resilience who are focused on this capability. Additionally, the benefits of any new innovations need to be consistent with the level of effort put into getting them to market.

Simon Agwale of Innovative Biotech, Nigeria also shared his experience with COVID-19 vaccine development and manufacturing in Africa. After their previous contract development and manufacturing company (CDMO) was unable to meet timelines,

Merck KGaA, Darmstadt, Germany

MilliporeSigma

EB connected Mr. Agwale and Innovative Biotech with 2019 EB Grant Winner – Technovax. Mr. Agwale described how they are now focused on developing a virus-like particle (VLP) vaccine for COVID-19 and currently have one for the Beta and Delta variants. Trials begin in Ghana, Nigeria and South Africa soon and will finish in the third quarter of 2022. Production of the new vaccine will be done in the United States until the new factory in Nigeria is constructed with full production to follow in Africa some time in 2023.

Given all the attention the biotech sector has had over the past two years, more innovations and news are sure to follow in 2022 and beyond.

Coronavirus (COVID-19) Vaccinations. https://ourworldindata.org/covid-vaccinations. Accessed December 7, 2021.

Simon Agwale

Simon Agwale, Ph. D is the CEO of Innovative Biotech, Nigeria and Innovative Biotech USA Inc. He is a member of the board of the African Vaccine Manufacturers’ Initiative (AVMI) and in 2019 was asked to lead their Covid-19 Vaccine Task Team. He is also an advisor to WAHO, and part of a recently established ECOWAS vaccines taskforce. He is currently the Lead (Technology and IP) of Partnership for Africa Vaccines Manufacturing (PAVM) of Africa Centers for Disease Control (AfricaCDC).
Dr. Agwale has a vision for the development and investigation of HIV vaccine constructs from prevalent Nigerian strains which are relevant to Nigerians. He is also currently developing novel vaccines against Covid-19, Ebola, cervical cancer, and HIV using innovative viral-like particles (VLPs). Through INNOVATIVE, Dr. Agwale is striving to further develop and refine these dynamic, novel treatments, and in doing so, expand domestic vaccine manufacturing capabilities in Nigeria to serve the African community.
Dr. Agwale was a Postdoc fellow at the Institute of Human Virology Baltimore, USA and Visiting Scientist at various institutions in Brazil, Germany, UK including the US Vaccine Research Center/NIH, and US Center for Disease Control and prevention in Atlanta. Dr. Agwale was West Africa’s representative on HIV/AIDS for Developing countries Coordinating Committee (DCCC) at European and Developing Countries Clinical Trials Programme, where he was also the chair of the African Scientists committee (DCCC). He is a recipient of several scholarships, fellowships and grants from reputable organizations around the world. He has also authored and co-authored numerous noteworthy publications.

Thomas Ransohoff

Thomas C. Ransohoff, M.S is currently Technical Head, Biologicals Franchise at National Resilience, Inc. (“Resilience”) and has over 30 years of experience in the biopharmaceutical industry. Mr. Ransohoff’s areas of expertise include development and scale-up of biopharmaceutical processes; separations and purification technologies; cGMP manufacturing; and management of technology-based start-up ventures. Before joining Resilience, Mr. Ransohoff was a Managing Director at BDO and its precursor BPTC, a leading CMC consulting firm that he helped build over a 20 year period. Prior to that, he held senior level positions at TranXenoGen, Dyax, Repligen, and Xoma. He is also a co-founder of several successful start-ups, including 4th Dimension Bioprocess, Tarpon Biosystems and BioFlash Partners. He serves on a number of scientific and professional advisory boards and holds a Bachelor’s degree from MIT and a Master’s degree from the University of California, Berkeley, both in Chemical Engineering.