[
DCMC Session
|
Presentations & Panel Discussion
]

Digital CMC Deployment: Real-World Use Cases | Digital CMC Summit | Presentations & Panel Discussion

How digital CMC sets up a foundation for organizational agility, workflow visibility, and robust process control.

Key concepts for successful implementation of digital CMC solutions, and how they apply to core CMC workflows. Where digital CMC solutions can be applied to mature substance classes and cutting-edge cell and gene therapies.How applying digital CMC principles can help organizations move from a project approach to a platform approach.

Discover how industry leaders are implementing digital CMC

In this series of expert presentations, transformation veterans from across the industry share their real-world experience with implementing, managing, and sustaining digital transformation in the CMC process.

As each of these six specialists explains, digitizing CMC operations is key to unlocking greater efficiency and productivity – both for established organizations and up-and-coming innovators. Each presenter offers a unique view of how digital CMC principles are already helping their team and organization achieve a new level of scientific and operational performance.

In this presentation series from the 2022 Digital CMC Summit:

  • Gloria Gadea-Lopez explains why implementing digital CMC solutions is a critical first step in helping her customers prepare for a successful transition to Manufacturing 4.0. She explains how the right digital CMC platform can help drug developers lay a foundation of trackable, reusable, collaboration-friendly infrastructure for their product programs.
  • Dr. Joschka Buyel offers an in-depth look at how his Bayer team manages the deployment of new digital CMC solutions, creates data taxonomies to maximize the value of those technologies, and leverages them to accelerate development of key assets like process descriptions.
  • John Maguire shares how digital CMC principles have helped the Sanofi mRNA Center of Excellence shift from a legacy project-focused approach to a strategic platform approach – one that is already enabling them to significantly increase their throughput of valuable mRNA products.
  • Steve Keizer delves into how his team at the Artisan Bio “Cell Foundry” discovered that a digital CMC platform can be the perfect development bridge between early-stage R&D workflows and commercial-scale GMP activities.
  • Dr. Amol Thote and Justin Grahek share how Bayer Pharmaceutical uses a digital CMC platform to both streamline development of well-established substance classes and create scalable development platforms for cutting-edge cell and gene therapies.

Don’t miss the group discussion at the end, where these six experts field some insightful questions about how they’re managing the interdisciplinary collaboration at the heart of any digital transformation process.

Session speakers

Watch this session

Legend
Legend
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

We’re here to help you deliver

No items found.
[
Biosystems Engineering
]

Gloria Gadea-Lopez

Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)

[
QbDVision
]

Joschka Buyel

Joschka Buyel is the Director of Product Management at QbDVision. He was previously responsible for the rollout and integration of QbDVision at Bayer and worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.

[
Sanofi mRNA Center of Excellence
]

John Maguire

With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.

[
Artisan Biotechnologies
]

Steve Keizer

[
Bayer Pharmaceuticals
]

Amol Thote

[
Bayer Pharmaceuticals
]

Justin Grahek