By Daniel R. Matlis
For this installment of our “2008 Learning from Success” series, I had the privilege of speaking with Mark Wagner, Vice President Worldwide Clinical Supply Operations and Sarah K. Doshna, Associate Director Parenteral Manufacturing Pharmaceutical Research Institute. They represented Bristol-Myers Squibb (BMS), the winner of the 2008 Facility of the Year Award for Equipment Innovation.
BMS’s Clinical Supplies Manufacturing and Drug Product Technology Center is located in New Brunswick, New Jersey and supports trials in 60 countries around the world.
This innovative facility was designed to accelerate time to market by bringing together formulation as well as early and late phase clinical manufacturing and development scale-up resources into a single site. This created the BMS Pharmaceutical Development Center of excellence.
To save time and cost, as well as minimize environmental impact, BMS chose to gut and rebuild an existing structure on the New Brunswick Campus. The team utilized a phased approach enabling them to leverage lessons learned in the integration of containment and process automation technology into existing operation.
Phase one included a state-of-the-art Clinical Supply Operations expansion facility-comprised of full containment for expanded Oral Solid Dose (OSD) operations. The site utilizes some of the most flexible clinical-scale continuous barrier line in the United States for Sterile products. The facility was designed to support manufacturing of OSD batches up to 400Kg and parenteral liquid fill batches up to 250L.
The goal was to create a flexible facility capable of performing multi-product clinical scale manufacturing and processing solvent-based and potent compound operations.
Key business drivers for the project included:
- Versatility- Capable of supporting Small Molecules and Biologics
- Flexibility - Movable equipment for easy re-configuration
- Multi-use – capable of running up t 5 products concurrently
Phase Two built upon the technologies in Phase One and added additional processing space and scale to the Oral Solid Dose clinical operation and a new stand-alone Product Technology Center for development scale-up activities. The addition of Oral Solid Dose Operations allows the manufacture of Long Term Stability batches within the Clinical Supply Operations facility in at least one-tenth commercial scale.
In my opinion, the most worthwhile lesson of the project was the use “sweat equity”. The phrase is used to describe the value added to houses by owners who make improvements by their own toil. The more homeowner labor applied to the home, the more sweat equity that has been used.
BMS appointed the facility’s owners Sarah Doshna and Neil Martin as the project’s leaders. Their teams were brought on board before the roof was up.
The facilities future technicians, operators and mechanics began by training and working on the legacy process, enabling them to learn what worked in the past, as well as providing opportunities to shape and improve the new process.
In addition to “sweat equity” here are a few more lessons from BMS’s Success:
1. Foster water cooler cooperation
Bringing team members together can solve and prevent problems
2. Open informal lines of communication
Tear down silos by leveraging knowledge fostering integration, commingling and shared learning
3. Involve QA early in the design phase.
Keeping QA engaged throughout the life of the project ensures continuity and minimize holdups
4. Plan and Design for technology integration.
Don’t wait till the equipment gets to the site
5. Integrate Process Analytical Technology (PAT) into the process
Is should not be an afterthought
6. Seamlessly Incorporate Electronic Batch Record (eBR)
Do not implement “Paper-on-Glass”, take full advantage of eBR capabilities
As a result of the “Sweat Equity” approach, the new facility provides BMS with the increased capacity to meet clinical demand and deliver Compliance, Productivity and Technical Innovation for present and future drug development pipeline needs.
An added bonus of this approach was the virtual elimination of the steep learning curve often associated with the startup of a new facility. After all, It’s easy to navigate through, and hard to point fingers at the decisions made in the facility you helped build.