The Apligraf Manufacturing Team from Organogenesis, Inc. (Canton, Mass.) has been selected as a “Team of the Year” by Pharmaceutical Manufacturing magazine. The team was chosen ahead of other nominees from small manufacturers. (Wyeth Consumer Healthcare’s Supplier Quality Excellence team is being honored among teams at large manufacturers—see related article.) They will receive a Team of the Year trophy, to be presented in person by Pharmaceutical Manufacturing’s editorial staff.
The annual “TOTY” awards recognize manufacturing teams in the life sciences industry that have undertaken sizable challenges, excelled in their work, improved facility morale and team spirit, and achieved measurable, meaningful results. The teams were selected by the magazine’s editorial staff in consultation with a panel of outside experts.
The following is an excerpt from a full article appearing in the November/December issue of Pharmaceutical Manufacturing:
Most pharmaceutical manufacturing teams are expected to be productive, well-oiled machines. In the case of Organogenesis’ Apligraf manufacturing team, there really is no choice. Apligraf is a living product—a circular matrix of skin and tissue cells (keratinocytes and fibroblasts) that is applied to chronic wounds to facilitate healing. The finished product ships overnight and has a 10-day shelf life; if the manufacturing team isn’t functioning properly, there simply won’t be product to deliver.
“Making a living product requires consistency and precision,” says Phil Nolan, Vice President of Manufacturing Operations. “We have to constantly be aware of what’s occurring within the process.”
The results of this commitment have been impressive:
• The team boasts an on-time delivery rate for the product of 99.8%. Guaranteeing supply availability and precise forecasting are just two areas in which the team has excelled.
• Over 200,000 applications of the product have been manufactured, which accounts for more than two-thirds of all patients treated in the world with living cells.
• Product sales have grown on average 30% annually for the past five years.
The team gets a sense of fulfillment from making a meaningful product—often the sales team will share successful Apligraf application stories and the dramatic increase in quality of life for the patient. “Associates can better appreciate the significance of their role in the production of this complex product,” says Nolan. “They see the effectiveness of it, the importance of it.” The team has an emotional connection to the product that is unique, Nolan says.
“We have a great deal of pride in the work that we do every day,” says David Bartorelli, Director of Facilities, Engineering and Maintenance. “We get a scorecard every day on our performance, and everybody on the team takes it very seriously.”
Tweaking for Success
Safety is a team mantra, as evidenced by the 200,000 statistic. “Safety can never be a concern for our patients,” says Production Director Cheryl McManamin-L'Heureaux. “We use tools like failure modes effects analysis and other methods to identify where the potential challenges could be in our process, so that either detection methods or process controls can continually be improved.”
Any operator who handles the product has the opportunity—rather, the obligation—to identify waste and ensure quality, says Bartorelli. “Whether it's the people in the shipping department, QC, or the production folks, everybody's empowered stop it, to speak out if they see something that doesn't look normal.”
“We handle every single unit with care, and every unit is 100% inspected,” says Ginger Abraham-Freel, Director of Cell and Tissue Banks. “There are many steps of the process. And that's how we guarantee that we have a high quality, safe product.”