Advanced Viral Vector Manufacturing for DSP

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(free of charge and without obligation)

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This course is the follow-on one from Advanced Viral Vector manufacturing for Gene Therapy – Upstream Processing (USP). The USP and DSP courses can be followed sequentially or stand-alone. The course content introduces what the different vectors used in cell, gene therapy and vaccine manufacturing are and a brief introduction to the processes how they are made. The production processes are described in detail, including the essential parts of the USP in order to understand the structure and properties of the vector, but also of the contaminating substances, which must be removed during purification.

The physico-chemical properties of the different types of viral vector and transfection agents are explained together with the critical quality attributes (CQA) of the drug substance. The challenges of the separation and purification are explained and developed, together with a detailed analysis of the yield and productivity of each step of the DSP, in order to define the steps which are critical to the process economics.

The focus of the course is on:

• A description of the physico chemical properties of the product and process-related impurities
• Definition of the critical quality attributes of the drug substance/ product
• Presentation of the USP and DSP of processes for production of mRNA, plasmid DNA and viral vectors
• Description of the different types of filtration systems used in manufacture of the drug products
• Description of the different types of chromatographic resins used in manufacture of the drug products
• Operating conditions for the chromatographic systems
• Chromatographic resins or membrane chromatography?
• Scale-up, process yield, productivity and quality (CQA) throughout the DSP
• Mass balances over the DSP process to facilitate process optimisation

This course is intended for people working in a research or production environment, in USP and/ or DSP, who have an understanding of DSP but wish to extend their knowledge in areas of viral and non-viral vector manufacturing. Some basic knowledge of gene or cell therapy techniques are required and the course level will be adapted according to the attendees needs. The course is suitable for biologists, engineers, cell culture specialists, process designers/ developers, process operators in DSP, and anyone with an interest in gene or cell therapy.

After completion of this course the participants should understand the principles of gene therapy and the application of viral and non-viral vectors, in particular the process by which vectors are produced for biomedical applications. The focus of the course is on the process steps and engineering, so that participants should understand how to design a DSP process, feel comfortable in choosing the right type of chromatography and filtration in order to achieve the level of purification and kinetics required.

The course is a mixture of interactive presentations and hands-on practical work in a GMP-like environment. Practical work will be carried out in small groups with a maximum of 2-3 people per group to ensure hands-on experience at all time.

This course is in collaboration with Pall Biotech, a leading manufacturer of  bioprocessing equipment.

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A certification will be handed out to each participant at the end of course.

Travel and accommodation are not included in the course fee. Flights can be booked to either Geneva or Zurich airport with a direct train connection from both airports to Fribourg.

Accommodation can be booked in the Alpha-Hotel (www.alpha-hotel.ch), which is only 5 minute food-walk away from the Biofactory Competence Center.

Register now and reserve your place