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Seminars & Webinars

2020

Presenter: Aleš Štrancar

Date: October 27, 2020

Gene Therapy for Rare Disorders Europe 2020 (digital event)

Bullet points:

  • Buffer optimisation and proper column ligand selection (CIM QA, CIM PrimaS or new CIM EF) allows for >90% full capsid production
  • Introduction of Specimen allows for production columns checking before use  
  • Using ultracentrifuge with set of HPLC detectors allows for prompt orthogonal verification of the full capsid purity  

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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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Messenger RNA is poised to become a major contributor in the fields of gene therapy and vaccines. Making this a practical reality requires purification technology that accommodates its unique features and challenges. Some of those challenges are inherent to mRNA. Others are byproducts of RNA synthesis.

This presentation addresses both and introduces a coordinated purification toolbox to advance the evolution of mRNA therapy.

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Presenter: Ingo Nagler

Date: June 3, 2020

Biomanufacturing and Cell & Gene Strategy Meetings (Proventa International's online meetings)

Click here to listen to BIA's Keynote Presentation

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Presenter: Ingo Nagler

Date: May 14, 2020

Asia’s SARS-CoV-2 Vaccine Development Challenges (Corona360 In-Conversation webcast series)

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Presenter: Pete Gagnon

Date: 23rd of January 2020

Place: Miami, FL (Phacilitate World Stem Cell Summit)

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2019

Presenter: Ales Strancar

Date: 20th of November 2019

Place: Boston, MA (Gene Therapy Analytical Development Summit)

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To listen to audio podcast online click here.

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Presenter: Pete Gagnon

Date: September 18, 2019

Place: Boston, MA (Exosome Based Therapeutic Development Summit 2019)

Exosomes BIA Separations

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Presenter: Ales Strancar

Date: 19th of June 2019

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

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