Continuous Manufacturing: Business Case Drivers and Deployment Strategies

Continuous manufacturing for Oral Solid Dose drug products has the potential to generate benefits in many different areas of the product lifecycle. It will help to improve control and understanding, increase development and transfer speed, assure shorter cycle times, and reduce development, transfer and operational cost.
If we look at the products which have been approved for commercial production, we see differences in technology, approach, and business case drivers. The main interest is coming from larger pharmaceutical companies, but also generic companies and CMO’s start to invest or have intentions to do so.
Before implementing a continuous manufacturing process, a number of strategic choices have to be made: start off immediately with new products or learn by converting a legacy batch product into a continuous process without the critical deadline of a launch on your path. A clear development and deployment strategy will help to guide for important choices early on.
This webinar will give an overview of the different elements that can drive the business case of a continuous manufacturing project, and which strategies could be used to deploy this wonderful technology throughout an organization.
Presented by Lawrence De Belder, Senior Principal Engineer Continuous Manufacturing at Johnson and Johnson

Lawrence De Belder is a Senior Principal Engineer at Johnson & Johnson Technical Operations, a group in the Janssen Supply Chain which provides support to Janssen Commercial Operations. He has 23 years of experience designing and implementing different Manufacturing Technologies of which 12 years in Pharma and 6 years in Oral Solid Dose Continuous Manufacturing.
He is the Program Manager for Continuous Manufacturing in the Janssen Supply Chain where he manages all projects and activities on continuous manufacturing for Oral Dosage Drug Product throughout the different parts of the organization.
He has published several relevant articles, represents J&J on the most important conferences, as a speaker or as organizing committee member and is leading several consortia (CM Work Group of the IQ Consortium, GEA User group, and CM Community of Practice at ISPE), where he connects the strongest experts in the industry within the landscape of Continuous Manufacturing in Solids Small Molecules.
 
Sponsored by GEA Group

With 14 years of inspiration, GEA has firmly established its longevity in the continuous manufacturing market. And having completed more than 70 projects involving a variety of filed and authorized products, including the first ever FDA-approved breakthrough therapy developed and manufactured using the ConsiGma^® platform, no other company has as much experience and done more to pioneer continuous manufacturing for the pharmaceutical industry.
Plus, as a long-established supplier of equipment and technology to a wide range of process industries, GEA offers a comprehensive portfolio of standard and custom-designed equipment, machinery and entire production lines, ranging from benchtop R&D solutions to completely integrated industrial-scale plant.
As an international supplier, we focus on core competencies to establish market leadership through innovation and deliver technological advantages to our customers and clients. For example, the GEA Pharma Solids Center (GPSC) in Wommelgen, Belgium, represents our continued commitment to and our ongoing support for the current and future pharmaceutical industry. From cost assurance and process enhancement to real-life simulations and test and loan machines, we provide a unique range of services that are designed to improve production and expedite time to market.
No matter where you are, how big or small the scale or whatever the application, we have the capability to make your concept a reality, optimize your process, improve your production efficiency and deliver the ongoing support to make your business a success. How do we do this? By making science work.(gea.com)
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Continuous Manufacturing in the Global Pharmaceutical Industry: Status, Drivers and Implementation
Pharmaceutical manufacturers face many challenges when developing new products and getting them to market in a timely, safe and a cost-effective way. Hurdles to overcome include formulating new molecular entities, the rise of personalized medicines, improving generic drug production and/or extending the lifecycle of existing oral solid dosage (OSD) forms, all while increasing patient safety, reducing the cost-per-tablet and optimizing the price/performance balance.
Continuous manufacturing (CM) provides a solution to these problems. Yet, the implementation of CM is a corporate-level “business excellence” decision as opposed to simply installing new technology to enhance certain product performance capabilities. If lead users embark on such a venture, they soon learn that the decision to implement continuous processing in their portfolio involves an organization-wide paradigm shift.
This presentation provides an overview of the pharmaceutical industry’s journey towards the implementation of fully integrated, continuous processes — from powder to coated tablets — and the strategies involved.
CM is no longer a niche trend. It’s already happening. Early adopters will benefit from competitive advantages. CM technologies are constantly improving, enabling those pioneers to keep pace with the paradigm shift, sustain their business excellence trajectory and stay ahead of the market.
presented by Richard Steiner, Business Development Manager at GEA Group

Richard Steiner is Business Development Manager for continuous oral solid dosage (OSD) systems at GEA. Previously, Richard held a number of management positions at Leistritz Extrusionstechnik GmbH and Raumedic AG, and is considered to be both a B2B marketing specialist and hot melt extrusion process expert.
He was educated at the University of Applied Sciences in Nürnberg and the FU University of Berlin, and graduated as a mechanical engineer, MBM and MBA. He has contributed numerous papers and chapters to a variety of scientific textbooks and is a frequent speaker at international conferences.