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Seminars & Webinars

2021

Event: Nucleic Acids- cGMP Production of mRNA & pDNA (virtual edition)

Date: February 1, 2021

Our new Head of Process Development for mRNA and pDNA purification, Rok Sekirnik, presented our Chromatographic tools for high-yielding mRNA production process as workshop.

Click here to listen to the workshop.


Event: Nucleic Acids- cGMP Production of mRNA & pDNA (virtual edition)

Date: February 3, 2021

Our CEO, Ales Strancar presented our Integrated Production Process of mRNA from E. coli to Highly Purified mRNA

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2020

Presenter: Aleš Štrancar

Date: od demand, October 19-22, 2020

Cell & Gene Therapy Bioprocessing & Commercialization  (digital event)

Established processes for pDNA manufacturing include purification steps designed to enrich the supercoiled (sc) isoform. Homogeneous supercoiled isoform improves cell transfection efficiency in fermentation processes and is favoured in cell culture production systems. In vitro transcription (IVT), the enzymatic process used for production of mRNA vaccines differentiates itself from biological fermentation processes by the need for linearised plasmid DNA. The linear isoform is produced with restriction enzymes from open circular and supercoiled plasmid DNA. Employing a traditional pDNA manufacturing process, which removes linear and open-circular isoforms, will therefore reduce the production yield. When plasmid DNA and mRNA are treated as a single production process, the purification steps can be optimised, yields improved, and the overall production cost reduced.

A new purification approach starting from E.Coli all through to mRNA production is presented here. This new approach integrates a pDNA linearisation step before polishing of plasmid DNA. The polishing step, placed after enzymatic linearisation, purifies linear pDNA from enzyme and other unwanted process impurities. The linearised plasmid DNA is then used in IVT for production of mRNA. This approach further introduces mRNA purification tools for improved contaminant removal. The altered sequence of purification and linearisation reduces the overall number of purification steps required, improves recoveries, while the complete process results in extra low protein impurity and very efficient dsRNA removal.

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Presenter: Aleš Štrancar

Date: August 27, 2020

2nd Bacteriophage Therapy Summit 2020 (digital event)

Many of the most compelling applications of bacteriophages involve human therapy, some pertinent to gene therapy, others to antibiotic replacement. These applications require removal of host cell contaminants to acceptable levels, including proteins, DNA and, most of all, endotoxins. This presentation will highlight some of the challenges with effective endotoxin removal, and introduce a new chromatography product that achieves good endotoxin removal while maintaining high recovery of bacteriophage. Case study data will be shared documenting the performance of a platform purification method that enable complete bacteriophage purification within a single shift. Fast analytical methods for qualification of raw materials and tracking phages through the steps of a purification process will also be presented.

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2019

Presenter: Ales Strancar

Date: 19th of June 2019

Place: Biomanufacturing Training & Education Center (BTEC) in North Carolina

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