Case Study:  Product Yield Improvement, Bio-Tech

The Company

The 250 million-dollar U.S. arm of a 700 million-dollar, European-based biotech manufacturing company.  Manufacturer of proteins used in growth hormones for the treatment of aids wasting.

The Problem

Shortfalls in product yields when compared to identical, sister manufacturing sites in Europe.  European operations consistently averages 60% yield, while U.S. operations yields are stalled between 49% and an occasional high of 57%.

The Approach

Gagnon Associates convinces senior executives of this traditional, top-down-managed organization to involve employees from the production organization directly in the problem-solving process.  Working with a small group of the eventual problem-solving team, Gagnon Associates consultants guide the process of problem scoping, definition and final team selection.  Significantly, in what represents for this company a unique bridging of a typically impervious geographical boundary, the company complies with Gagnon Associates’ advice and agrees to include two European manufacturing representatives in the problem-solving process.   The final problem-solving team comprises several first-line manufacturing technicians, representatives from quality assurance, a manufacturing process engineer, manufacturing supervisors and the executive director of manufacturing.

The session that results, facilitated by Gagnon Associates, is an intensive, three-day problem-confrontation meeting focused on finding and eliminating barriers to increased product yield.  Among other problem aspects, the team thoroughly investigates issues such as:  product storage containers, filter and other equipment issues; key process concerns, such as process sequence and timing, product collection, testing and storage; possible yield calculation and process discrepancies between U.S. and European operations, etc.

Throughout, Gagnon Associates catalyzes and facilitates the process by providing real-time, work-group leadership as well as “just-in-time” training and coaching on underlying problem-solving tools and techniques.

The Results

Within seven months (four completed production runs), implementation of team recommendations increases average yield for U.S. operations to 64% — well above the target, and the equivalent of $3 million in additional sales revenue potential.  Improvements also increase product purity so significantly as to result in shorter cycle times for downstream product processing.

In addition, managers in the production area report an interest among employees in participating in “the next session” of this type.  This from an organization with a history of non-involvement and low morale that had experienced turnover rates as high as 46%.