New Challenges in Vaccine Production During Global Pandemics
by Nelson Landrau, CEO/Founder; Malcolm G. Pluskal, PhD.
How a Leominster, MA company is providing resources and expertise to support national and worldwide vaccine production
Massachusetts has encouraged and supported Biopharmaceutical R&D and large-scale Biologics manufacturing throughout the last 30+ years and has become one of the world leaders in development of new technology platforms. Influenza, SARS, and the recent COVID-19 pandemic, have increased the demand for novel vaccine production technologies to bring these vaccines to market quickly and in large quantities.
This demand has stimulated development of new mRNA-based vaccines by local companies in the Boston area. These new oligonucleotide-based vaccines offer great flexibility with respect to production and applications. This scientific approach will enable any protein to be encoded and expressed by an in vitro transcribed mRNA. In principle enabling the development of wide range of prophylactic and therapeutic vaccines to fight a broad range of diseases. To illustrate this diversity, this technology platform is being applied to fight diseases such as viral infections, cancer, and protein replacement therapy. During the production of this novel therapy only the mRNA sequence of the therapeutic target molecule is optimized. This enables diverse products to be manufactured using the same established production process, saving time and reducing cost as compared with other vaccine platforms.
Although mRNA therapy is diverse and can create new vaccines in relatively short time period (as compared to other vaccine technology approaches) new manufacturing challenges have arisen to produce the large quantities of these novel vaccines to fight outbreaks such as COVID-19. As we react to this pandemic with this new class of vaccines based on mRNA and large molecule biologics, such as monoclonal antibodies future large-scale purification workflows will be challenged to meet production goals, regulatory requirements, and cost. Large scale production, packaging and formulation to facilitate long term storage and deployment of these new vaccines will be key to their success. For example, mRNA-based vaccines are being formulated in charged liposomes to enhance their intra-muscular uptake and delivery to the body’s immune system leading to in vivo production of therapeutic and viral neutralizing autoantibodies.
To meet some of these vaccine production demands several new purification technologies are under development in Leominster MA, to accelerate bringing these COVID-19 vaccines to market; 1) Immunoaffinity resins for harvesting recombinant vaccine candidates from cell culture. This approach, taken by the University of Queensland for their “clamp” viral antigen was first evaluated on a new orientated immobilization affinity bioprocess optimized resin developed in by LANSI. This new resin offers high antibody binding capacity while preserving full antibody-antigen binding efficiency. 2) mRNA vaccine candidates generated by in vitro transcription are being purified on oligo dT affinity resins targeting Poly A+ sequences on the 3’ end of the mRNA molecule. Existing first generation R&D oligo-dT affinity resins were based on cellulose beads not fully optimized for large-scale bioprocess applications. A new cellulose-based Oligo dT resin is under development at LANSI in collaboration with the Oligo Factory (Holliston, MA) based on resin beads that have been optimized for large scale bioprocess applications. Formulation of these novel vaccine candidates to confer stability and enhanced immunogenicity and delivery are in development at LANSI to support bringing these new vaccine molecules to market.
If your company has an mRNA or expressed protein viral antigen that you are looking for assistance in scale-up, purification, or formulation, please feel free to reach out to us for a complimentary confidential consultation at 978-537-2890 or write to us at firstname.lastname@example.org. We have many years of experience in these fields and we are available to help you with your technical and product development needs.
What is a Guest Columnist?
Being a member of the North Central Massachusetts Chamber provides members with many opportunities to gain valuable information and connections. We are always on the lookout for valuable content that would be on interest to our members and communities. In an effort to provide an avenue to more easily access the vast array of the knowledge and expertise that our members possess, we are now offering exclusive Guest Columnist articles for the benefit of our members. As a membership based organization, submissions will only be considered from members at the Business Choice level and above.
This is a great opportunity to position your business as a thought leader and expert. Columns should not be self-promotional or sales oriented ,and should consist of content that would be useful to businesses, including tips, answers to important questions and any insights that would be helpful to fellow members. By participating, members have the chance to better inform, educate and aid in the development of other members and the North Central Massachusetts region.
Please contact David Ginisi, Marketing and Communications Manager, if you are interested in participating: DGinisi@northcentralmass.com | 978.353.7600 x240