Parallel Workshops

ABL Europe is a leading CDMO providing GMP manufacture of virus-based oncolytic therapies, gene therapies and vaccines. ABL's CDMO services include bulk drug substance, live virus fill/finish of drug product, process and assay development, and bioanalytical testing. ABL has extensive experience working with diverse organizations — including industry, biotech, and academic entities. ABL Europe maintains 2 clinical GMP facilities meeting U.S. and European regulatory standards based in Lyon & Strasbourg, France.

Workshop summary : How to optimize viral vector industrial manufacturing for gene therapy ?

Viral gene therapy has gained momentum after recent approvals and commercial successes with novel therapies based on direct virus-mediated gene modification. Viral vectors such as adenovirus, adeno-associated viruses (AAV) or lentiviruses are the foundation of such therapies, and their manufacture is not without challenges. With the growing demand for these vectors and the desire to target large organs, higher virus titers are required; higher titers enable the number of batches to be minimized and reduces the cost of manufacturing.

During this workshop, we will discuss the challenges related to the biomanufacturing of viral vectors for gene therapy, but not only … as viral vector based vaccines are also back on the stage with the COVID-19 crisis

• Challenges in production, quality controls, CMC strategies & fast track approaches in the context of the pandemic situation

André Dupont : Qualified person, Lyon site – Guillaume Sirgue : Production Manager, Lyon site – Stéphanie Colloud : Site director, Lyon site

bioMérieux develops and produces in vitro diagnostic solutions (systems, reagents, software and services) for private and hospital laboratories, mainly for the diagnosis of infectious diseases. The results obtained from a patient sample (blood, urine, stool, cerebrospinal fluid, saliva, etc.) provide doctors with information to support their decisions.

MGA Technologies is specialized in the design and assembly of custom-made machines for the most restrictive industrial environments: biopharmaceutical, medical, semiconductors & high technologies. We target manufacturing excellence with world leaders and the most innovative companies.

Workshop Abstract

To face new challenges inherent to MTI and mRNA processes and quick shifts consecutive to outbreaks, the biopharma industry needs to implement 4.0 technologies in new biopharma workshops, more flexible, more productive, more secured and evolutive. Such new concepts and innovations, like in the new Sanofi EVF project, will allow :

- to derisk projects and to speed up industrial ramp-up for new products and new processes,

- to reduce cleaning times, changing time between processes, manufacturing costs and carbon impact,

- to develop innovations dedicated to leveraging value of process, digital and mechatronics integration.

MGA Technologies, Stäubli, Siemens and all members of the new MGA TechLab 4.0 are ready to assist Biopharma companies in their exciting challenges !

Speakers :
Hervé de Malliard, President of MGA Technologies
Bruno Tricoire, Head of EVF MTech at Sanofi
Jacques Dupenloup, Head of Robotics Division at Stäubli France

Pall Corporation provides critical filtration, separation and purification solutions to meet the demanding needs of a broad spectrum of life sciences and industrial customers around the globe. Across 80 locations and 10,000 people worldwide, we are unified by a singular drive: to solve our customers' biggest fluid management challenges. And in doing so advance health, safety and environmentally responsible technologies.

Summary : 

Final fill is arguably the most quality sensitive section of the biopharmaceutical process. Often, it involves a close working relationship between the producer, the hardware supplier of the final fill apparatus and the single-use supplier.

It is crucial that a trusted relationship is present and that the product contact apparatus have quality built in and documented assurance of process suitability. This means, the right materials, the right documentation, and the right design, including formulation, filtration, fluid management, storage and final fill.

During this workshop we will discuss best practices for:

• Defining and implementing single-use assemblies for fill and finish operations
• Implementing practical solutions for safe Pre-Use Post-Sterilization Integrity Testing in different filtration configurations

Lionnel Lueginbuehl : Team Manager, Scientific and Laboratory Services - Elodie Ly : Regional Marketing Manager - Claire Durand : Biotech Specialist