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Seminars & Webinars

2021

Presenter: Ivana Petrović Koshmak

Event: 2nd Annual Gene Therapy Analytical Development EU

Date: May 26, 2021

Abstract:

In-process analytics of vector capsid production is a critical optimization target in development of AAV-based gene therapy products. In this presentation we introduce a fast at-line HPLC based system that enables differentiation of vector capsid and empty capsid production in transfection mixtures. Case study results  demonstrating the effects of different process variables on capsid production and assembly are shown and insights about purification are also discussed.

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Presenter: Aleš Štrancar

Event: Genetic Vaccine Development for Infectious Diseases Summit

Date: May 20, 2021

Abstract:

  • Developments in gene therapy and threat of pandemics requests novel technologies to allow for efficient manufacturing of very large biomolecules and nanoparticles within short time.
  • Convective Interaction Media with open channel structures resulting in no shear forces allows for fast and very efficient manufacturing of mRNA, pDNA, Adeno and other VLP based Covid vaccines.
  • Ultra-sensitive DNA assay and fast in-process control using PATfix systems are introduced for production of safer Covid vaccines.

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Presenter: Aleš Štrancar

Event: ASGCT 24th Annual Meeting

Date: May 13, 2021

Abstract

Adeno associated virus (AAV) is the leading vector in the field of gene therapy because of its low toxicity, good overall safety profile, and ability to maintain stable expression for long periods of time. It is therefore crucial to develop a robust and high efficiency platform for its manufacturing.
Therapeutic applications of AAV-based gene therapy vectors require the process and product related impurities to be removed, as they represent serious safety threats as well as burden the economics of manufacturing.

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Event: BioProcess International COVID-19 Therapeutic Development & Production

Date: April 27, 2021

Developments in gene therapy and the threat of pandemics requires novel technologies to allow for efficient manufacturing of exceptionally large biomolecules and nanoparticles within a short time. Novel vaccine platforms such as mRNA enable the industry to meet its highest goals: decreasing footprint while increasing efficiency and throughput. However, to respond with agility and prepare for future outbreaks, the mRNA platform must be further optimized.

In vitro transcription (IVT), the enzymatic process used for mRNA vaccine production, is different from biological fermentation processes as it requires linearized plasmid DNA. The linear isoform is produced with restriction enzymes from open circular and supercoiled pDNA. Employing a traditional pDNA manufacturing process, which removes multimers as well as linear and open-circular isoforms, reduces production yield.

However, when pDNA and mRNA are treated as a single production process, the purification steps are optimized, yields improved, and overall production costs reduced. This presentation will describe how Convective Interaction Media monoliths can be used to efficiently purify a board specter of mRNA and cover all production scenarios.

This presentation illustrates fast in-process control methods using the PATfix system, which can ensure the rapid production of the safest possible Covid-19 vaccines while reducing manufacturing costs.

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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

Click here to listen to the presentation.

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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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