Tuesday, September 24, 2024 - Day One of Main ConferenceTuesday, 24 September 2024 - ET (Eastern Time, GMT-05:00)

The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in biopharmaceutical development and manufacturing. The active drug substances have become more structurally complex and R&D timelines continue to be compressed, the technologies necessary to provide safe, robust and economical access to these molecules needs to keep pace. Emerging technologies such as continuous processing, automation, high throughput experimentation, predictive modeling in an integrated fashion can expedite process development and commercial manufacturing while ensuring efficiency and delivering quality products. All these aspects help to minimize the time and cost associated with development and manufacture of drugs and bring medicines to patients more effectively. This presentation will share AbbVie’s strategy and experiences in integrating such end-to-end technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.

Given the complexity of biological products, effective control strategy and life cycle management are critical to delivering quality products with intended efficacy. This presentation will focus on an overview and guidelines to develop and implements analytical control strategy approach to streamline and harmonize quality control testing and method life cycle.

We will explore how novel clarification technology, based on advanced synthetic fibrous chromatography materials, will enable new bioprocess strategies to address critical challenges in process simplification and intensification. We will illustrate how this platform can offer seamless implementation of chromatographic clarification from discovery to clinical and commercial manufacturing, providing consistent and high-quality clarified fluid and enhancing commercialization productivity.

• A software-based control system with islands of automation enables design flexibility in clinical biomanufacturing unit operation selection, integration, and interaction. A software-based control system solution can also provide portability of technology and control strategies during process scale up.
• Enabling automated solutions of data collection early in the process will support data integrity in more complex process integration efforts & future process improvements. Data collection should include more than just critical process parameters. To enable analytics for future application, it is critical to consider data management of analytical data, raw spectral data, and process metadata.

As ill-fated hopes from digital strategies (including AI/ML) fail to propel organizations to being first to market, many are left wondering why. With the diversity of data and software needs from Research through Manufacturing, well-intentioned companies quickly find that digital collection is far easier than digital connection. So how can groups glean transformative and meaningful insights in their pursuit of cost-effective and robust processes, with disjointed data management? How can biopharma expand their process understanding to better bridge the chasm between development and production groups, and enable more successful tech transfers? Join us as we discuss several bioprocessing strategies including the benefits of using of an integrated digital data backbone, the simplicity of a continuous tech transfer process, and how an advanced analytics engine can facilitate comprehensive reporting and analysis for users of all backgrounds.

Shifting from batch to continuous manufacturing is a promising way of lowering manufacturing costs of by allowing operations to run simultaneously with reduced downtime, higher productivity, and at several-fold smaller scale. This is particularly promising for gene therapy products using recombinant adeno-associated viral vectors (AAV), as treatments currently cost up to USD 3.5 million per patient and have high cost-of-goods ranging up to USD 1 million per dose. In this talk, we present approaches for intensification of downstream AAV manufacturing processes using principles of continuous processing.

• Grab a 'Cloud Spritz' (Aperol Spritz)
  • Culture Bioscience's booth (328)
• Grab a SmartLabs 75 (French 75)
  • SmartLabs Booth (1824)