Business Case Drivers and Deployment Strategies in the current Landscape for Continuous Drug Product Manufacturing

Lawrence De Belder, M.Eng
Johnson & Johnson

In the first section of this presentation, a high level overview of the current landscape will be painted: what are the current most important vendors, what are their capabilities, what types of machines do they have, what level of integration do they offer, what is their future strategy, how do they interact with each other. An overview will follow of where most Big Pharma Companies are at, how they collaborate and how Academic research serves the industry and regulators to ramp up Continuous Manufacturing Knowledge as fast as possible.

Reflecting on this overview, we notice that although the benefits seem obvious and significant, large scale deployment in the commercial environment is awaited for most part of the Industry. Why is that? Trust seems to be a key factor, and an attempt will be made to find ways to gain enough trust for leaders to accept the assumptions that are made in business cases today. Zooming into Business Case creation, a breakdown will be described of the different clusters of benefits, and which benefits can easily be overlooked. The questions will be answered which benefits could be more important than others and why, what could be hurdles to achieve these benefits, and what are the big elements to consider when preparing for implementation. Some of the lessons learnt from the feasibility and implementation of the FDA approved Continuous Manufacturing product of Janssen will be added to the conversation.

Several deployment strategies will be discussed that could fit in different organizations. Special attention will be given to the impact of different control strategies, regulatory requirements, and current regulatory practices on the achievement of the benefits that Continuous Manufacturing promises. Also will be discussed why alignment between different health authorities is critical and how regulators could help to expedite deployment of this technology in the Pharmaceutical Industry.

Finally, a real case study with fictive numbers will show in detail how an operational business case could look like in detail, specifically for a batch to continuous conversion. The exercise will show what benefits can be used in the calculations, how the assumptions are built up and which benefits might be more difficult to take up in the equation. Several references to the first FDA approved Continuous Direct Compression product will be made.

The audience will be invited to work together on generic calculation tools that could be helpful for the complete industry, offering benchmark numbers and standardized calculations.