On May 12th, the biaseparations.com website will be retired and migrated tosartorius.com.Learn moreabout our combined offering today!

Seminars & Webinars

2024

Event: LabRoots Webinar
Date: January 24, 2024
Presenter: Marko Narobe, Sartorius BIA Separations

The downstream processing of virus particles, vesicles, RNAs, plasmids and other forms of DNA, contains multiple interdependent steps, each requiring optimization for best results.  This webinar will showcase how to shorten the development time by screening multiple conditions at once, with small sample intake and process automatization. In these processes we used our newly launched CIM® monolithic plates.

The CIM® monolithic plates are a standard plate design, manufactured according to ANSI standard. In each well there is a defined amount of monolithic chromatographic media. Due to its intrinsic properties the mass flow through the monolith is convective. This enables us to have fast processes, and no shaking or incubation is required with our plates.  

First, we present the screening of different mobile phases for rAAV capture step. Optimization of capture step leads to increased process productivity and product purity, as well as improves the polishing step. High vector recovery and greater reduction of impurities translate to preparative scale.

Subsequent part of the webiar focuses on the importance of finding conditions that increase dynamic binding capacity (DBC) of mRNA on Oligo dT. Screening experiments help to to identify the factors that affect the binding capacity and achieve a DBC of >6 mg/mL.

In both cases, the optimized conditions were scaled-up to preparative scale chromatography, resulting in successful implementation of screening tools for process development optimization. Watch the webinar to learn how CIM® (Convective Interaction Media) monolithic chromatography products solve challenges in DSP for gene therapy and vaccines.

Full view

2023

Event: mRNA Process Development & Manufacturing Summit USA
Date: September 27, 2023
Presenter: Aleš Štrancar, Sartorius BIA Separations

Attachments

Full view

2022

Event: Cell and Gene Therapy Insights webinar
Date: June 7, 2022
Presenter: Nejc Pavlin 

Pre-developed and validated PATfix analytical methods using different column chemistries enable:
-    Effective control over linear plasmid upstream and downstream,
-    IVT reaction optimization for mRNA synthesis,
-    Control of yield, purity and downstream process of mRNA,
-    mRNA formulation and stability analysis,
-    Scale-up optimization.

In this webinar, will discuss a robust analytical tool PATfix™ platform, and its specific methods for pDNA and mRNA analytics that enable efficient monitoring of key upstream and downstream process steps will be showcased.

Full view

2021

Published: Cell & Gene Therapy Insights 2021; 7(10), 1437

Date: November 15, 2021

Presenter: Nejc Pavlin, Project Manager in Process Analytics Development department

Watch the video or read the poster to learn:

  • The importance of pDNA as an enabling product in the production of mRNA, AAV, and other therapeutic vectors
  • How the PATfix™ pDNA platform using CIMac™ pDNA column offers fast and efficient solution for problems related to pDNA upstream and downstream processes
  • How the PATfix™ pDNA platform can be used to optimally adjust pDNA production and purification procedures of pDNA according to your needs, increasing pDNA yield and purity and reducing the cost of its production

Attachments

Full view

Presenter: Aleš Štrancar

Event: BPI and Cell & Gene Therapy Bioprocessing & Commercialization 2021

Date: September 30, 2021

Abstract:

Global demand for pDNA production is at an all time high, due to increased need from Gene Therapy ramp-up. pDNA, as an enabling product, is critical in production of mRNA, AAV and other therapeutic vectors. Increasing yield and purity in the production of pDNA is a vital step in meeting such demand. Supporting reliable in-process control during pDNA purification, PATfix pDNA analytical platform is enabling rapid process development and optimization while providing a reliable analytical platform for production runs.

Attachments

Full view

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.

Attachments

Full view

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.

Attachments

Full view

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.

Attachments

Full view

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.

Attachments

Full view

2019

Presenter: Ales Strancar

Date: 19th of June 2019

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

Attachments

Full view