Pharmaceutical and biopharmaceutical manufacturers are challenged on many fronts, such as managing regulatory requirements, operating efficiency, and maintaining the right data required as part of the medicines and products produced.Emerson’s Michalle Adkins was recently at a Life Science Symposium Update session in Europe attended by more than 50 pharmaceutical and biotech company representatives. This symposium addressed three key areas challenging the industry:
- Managing Data Through Product Life Cycle
- Process Intelligence & Analytics
- Flexible Facilities and Single-Use Technologies
Michalle led the session on improving ways to manage data across the lifecycle. The session provided an opportunity for these manufacturers to share their perspectives on the various challenges affecting the industry now and into the future. It provided an opportunity to discuss technologies, applications and best practices outside of the traditional scope of instrumentation, process control and automation.
This open discussion also help identify areas where technology advances would help to improve this data management, analytics, and increased flexibility to support the changing business requirements.
With the October 12-16 Emerson Exchange conference in Denver rapidly approaching, Michalle noted that the Life Sciences / Pharmaceuticals Industry Forum will focus on automation innovation from research and development through manufacturing based on ISA88 batch control guidelines. Here’s the abstract for the session:
Tracking a medicine from R&D to Manufacturing cycle is a daunting task in today’s islands of automation framework. However, single purpose solutions at each level of the cycle have improved efficiency and contributed to the formation of the islands of automation. S88 has become an innovative approach that can thread these islands into a product lifecycle frame work from R&D to manufacturing and beyond. Johnson & Johnson’s approach to a Recipe Management Framework is used effectively to achieve product lifecycle management. The approach leverages its vertical integration from instruments to MES and creates a horizontal flow of data across the product lifecycle. This framework works for both traditional and single use manufacturing technologies.
Single use is becoming an important manufacturing technology in the Biologics research and development. A little over two years ago Amgen embarked on a journey to build a commercial manufacturing facility leveraging single use technology to meet core business requirements driven by a changing industry landscape.
This industry session will have a great mix of perspectives with representation from manufacturers such as Amgen, Johnson & Johnson, Mallinckrodt and members of the Emerson Life Sciences consulting team. Like the European Life Science Symposium Update, this Industry forum session will provide an opportunity to discuss the key issues and identify gaps with current technologies and solutions.
Here are some of the other Life Sciences-related happenings at the Emerson Exchange conference.
We hope you can join these sessions in Denver. If not, make sure to connect and interact with other pharmaceutical and biotech experts in the Life Sciences group in the Emerson Exchange 365 community.