Quality by Design & Successful scale-up
A key aspect to the CMC documentation of biological products is the application of the Quality by Design (QbD) principle.
The QbD approach is heavily based on prior knowledge with a detailed understanding of both product and process variables.
With Pall Corporation team, participate and reflect on several topics and guidelines:
- QbB Quality by design & AAV with Emmanuelle Cameau and Meriem Bendouma
- QbB Quality by design & Single use technologies, digitalization with Maryse Clauson
- Accelerator Vision Platform, the digital ally with Laura Demont
This workshop addresses the question how QbD can be applied to adeno-associated virus (AAV) gene therapy products and collects initial thoughts on where data gaps or interpretation uncertainties of the regulatory framework impede the chances of regulatory approval.
Functional Cell-based Bioassays for Biologics development
Moderator: Florian Mignot, Cell-based assays Specialist, PROMEGA
Due to their high degree of complexity, the development of Biomedicines requires a complete set of quantitative, reliable, reproducible, and accurate bioanalytical tools. Promega's R&D has developed a wide range of ready-to-use functional bioassays, based on Bioluminescence, to characterize and develop new innovative therapies such as monoclonal antibodies or cell therapies.
Our Potency cell-based assays are used in all phases of R&D, from exploratory to development, including QC lot-release.
Our focus will be on our cytotoxic ADCC and PBMC ADCC assays. We will also present our new Lumit technology, a very fast and easy to use immunoassay based on Bioluminescence, which allows to follow the immuno-modulation induced after a treatment.
Collaborative Engineering: Needs and Challenges in developing automation solutions for Life Sciences applications
Moderators: Paul Kendall - Industry Sector Manager, North West Europe – LifeTech; Boutheina Merad – Technical Sales Engineer - LifeTech
Are you a scientist, lab lead/technician, laboratory automation engineer or instrumentation guru who likes to bring ideas into life?
Are you frustrated in giving all your needs to only one organisation and losing control of your project?
Join Festo for this interactive workshop and discussion focused on the opportunities and successes that collaboration can provide. During this session we will collectively explore what are the critical factors and what approach and supporting tools can really drive success.
Choose the right strategy and the right partner for innovative therapies manufacturing ? Return of experience & case studies of CMC leaders of biotech start-ups & pharma companies
Moderator : Stéphanie COLLOUD, Site Director, ABL Europe
Panelists : Nicole Brument, Head of CMC & Supply Chain, COAVE THERAPEUTICS ; Carole Schwintner, Chief Technology Officer, MAAT PHARMA; Kristell Lebozec, Head of Pharmaceutical Development, ACTICOR BIOTECH; Valérie Griffond, Associate Director of CMO/CRO Strategy, SANOFI
Creating vaccines and biotherapeutics requires the right ingredients at the right time. The lack of process development and manufacturing capabilities within many of the companies developing innovative therapies as vaccines, gene therapies or microbiome based therapies represents a major challenge, reinforced by the pandemic situation. Accelerated timelines put pressure on academic institutions, biotech start-ups, and pharma companies to decide early in the clinical process the best path forward to manufacture, and ultimately commercialize, their product candidates.
Selecting the right manufacturing strategy & partner to bring innovative product from clinical to commercial production is key to navigating bioindustry challenges and realizing opportunities to get product to market faster.
ABL, along with Mabdesign, invited 3 leaders to discuss their company’s current status & manufacturing strategy, biggest needs/key drivers and share their own experience selecting & partnering with CDMO. The case study presentation will be followed by an interactive Q&A session with the audience.