How Digital Transformation can Support Next-Generation Process Development and Biomanufacturing

Across the biopharmaceutical industry, the transition from traditional constructs such as large stainless-steel factories, batch manufacturing, and paper-based recording systems to modular facilities, single-use technologies, continuous manufacturing, and electronic systems is picking up pace. It’s easy to see why: the benefits of greater agility and responsiveness for capacity planning, significantly reduced manufacturing costs, and improved product quality speak for themselves. This is particularly important for the emerging field of advanced therapeutics such as cell and gene therapies. Yet despite all the scientific and technological advances, the issue of how to effectively manage data, workflows, and knowledge across the development lifecycle remains a stumbling block.

Join Eliot Randle and Claire Hill as they discuss what’s needed to address the current industry challenges and transform the future of biomanufacturing, including:

• What does digital transformation mean for bioprocess development
• Cell and gene therapies: how do their challenges compare to traditional biologics
• Balancing the requirement for flexibility, agility, and responsiveness with standardized data capture and reporting
• Data standards: why have previous attempts failed and what are the most promising new development
• Breaking down the barriers between research, development, and manufacturing
• Improving reproducibility and increasing automation

What you will learn

Participants will learn about:

• How digital technologies can transform bioprocess development
• What cell and gene therapy companies can learn from biologics
• How to break down the communication barriers between R&D and manufacturing
• Why software can help improve reproducibility in process development

Who should attend?

• Senior-level pharma R&D scientists and leaders involved in:
• Process Development
• Analytical Method Development/QC
• Tech Transfer/GMP Manufacturing
• Regulatory Compliance
• Outsourcing
• Project Management
• Excellence/Innovation
• Operational Oversight

Dr. Eliot Randle, Managing Partner and Co-Founder, Digital Lab Consulting

Dr. Eliot Randle MBA is a managing partner and cofounder of Digital Lab Consulting, an independent strategic consulting company that enables organisations to transform their business through better use of informatics. With more than 20 years’ experience in the biopharmaceutical industry across the entire value chain from R&D to manufacturing and clinical, Eliot has a track record of delivering business transformation for clients.

Claire Hill, Solutions Support Manager, IDBS

Claire Hill helps ensure that customers realize the full benefit and transformational impact of IDBS’ solutions. Claire has a Master of Science in Biochemical Engineering and an MBA and previously worked as a financial analyst for IBM and as a bioprocess consultant for BioPharm Services.