Tuesday, September 24, 2024 - Day One of Main Conference - EST/EDT (Eastern Daylight, GMT-4)
Tuesday, September 24, 2024 - Day One of Main Conference - EST/EDT (Eastern Daylight, GMT-4)
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
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.
- Moiz Diwan - Director, Purification Development, Biologics Development - Operations, AbbVie
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.
- Udayanath Aich, Ph.D. - Associate Director, Bristol Myers Squibb
- An update on NIIMBL’s activities working towards key fundamentals
- Security of supply chains
- Flexibility of facilities to match varied and changing demand across portfolios of products
- Faster development with supply chains that can match this
- Sustainability for raw materials, components, and energy
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
- John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology
Next generation manufacturing through implementation of advanced technologies is one of the current focus areas to enable agile, reliable, cost-effective, and timely production of biopharmaceuticals at highest quality standards. New modalities beyond standard mAB characteristics and complex supply chain logistics in a VUCA environment are factors to consider when designing the plant of the future and will impact the competitive advantage through application of advanced technology concepts. The talk will provide examples of deployment in context with business needs and added value.
- Marcel Tigges - Senior manager, Janssen
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.
- Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals