Engineering and Managerial Challenges and Opportunities in Vaccine Production

 

Plasmid manufacture is the bottleneck of the genetic medicine revolution

Jonny Ohlson

Drug Discov Today. 2020 Nov; 25(11): 1891–1893.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564888/

The global cell and gene therapy market is experiencing substantial growth. Having been valued at $1 billion in 2018, it is projected to have grown to over $14 billion by 2025.

Aldevron, which currently has the largest GMP plasmid facility in the world, expects to open a new 189,000 sq. ft manufacturing facility in spring 2021, adding to its existing space in Fargo, North Dakota.

As an alternative to plasmid DNA production, Touchlight has developed synthetic DNA manufacturing using an in vitro dual enzyme process.

In 2021, Touchlight is planning to more than triple its manufacturing capacity in London with the addition of 10 production suites, enabling production of over 1 kg of dbDNA per month.

Nanotechnology shows promise for next-generation vaccines in the fight against COVID-19

Published online by Cambridge University Press:  10 December 2020

https://www.cambridge.org/core/journals/mrs-bulletin/article/nanotechnology-shows-promise-for-nextgeneration-vaccines-in-the-fight-against-covid19/8901FB9495039B28EB2E0C9F49187E35

Process Development of Microbial Plasmid DNA: Fast-Tracking with Modular Single-Use Minibioreactors

by Barney Zoro and Andrew Frazer

Tuesday, September 19, 2017  

Real-world operation of a plasmid DNA product development program at Cobra (including screening and fermentation development stages) using the same single-use bioreactor provided a 70% reduction in project timelines — from 46 weeks down to 14 weeks — compared with the same process based on a combination of shake flasks and autoclavable benchtop bioreactors (Figure 5). That increased productivity came from higher culture throughput and improved confidence in data quality.

Those time savings allow for a significant acceleration in clients’ clinical development programs. It speeds programs to initial clinical studies and helps during later stage development when the time available to perform process development activities is restricted by the potential of complicating clinical development programs.

https://bioprocessintl.com/upstream-processing/upstream-single-use-technologies/single-use-minibioreactors-process-development-of-microbial-plasmid-dna/

Now a process must be created through which plasmids can be produced in sufficient quantities as High Quality Grade material.

In contrast to previously available methods, which were qualitatively and quantitatively sufficient for the production of plasmid DNA for research applications, now a process must be created through which plasmids can be produced in sufficient quantities as High Quality Grade material.

Due to the high quality requirements, this is a demanding challenge, which PlasmidFactory faces today both in the field of fermentation and chromatographic processing of the DNA product.

However, due to its expertise, PlasmidFactory plays a pioneering role here - paving the way for vaccine production.

https://plasmidfactory.com/news/production-of-starting-material-for-mrna-vaccines-in-large-quantities

Rapid Process Development for High Yield Plasmid DNA Fed-batch Fermentation - Case Studies

November 1, 2009

Clague P. Hodgson , Aaron E. Carnes , James A. Williams

BioPharm International, BioPharm International-11-01-2009, Volume 22, Issue 11

https://www.biopharminternational.com/view/rapid-process-development-high-yield-plasmid-dna-fed-batch-fermentation

Google search "bioreactor design for fermentation of covid plasmids"