Team of the Year 2008 (Small Manufacturer): Organogenesis' Every Day People

“That was a great example of combined teamwork,” says Ginger Abraham-Freel, Director of Cell and Tissue Banks. “We got together, performed a root-cause analysis, and came to a resolution in an effective manner.”

Tweaking for Success

Safety is also a team mantra, as evidenced by the 200,000 statistic. “Safety can never be a concern for our patients,” says McManamin L’Heureux. “We use tools such as 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 be continually improved..”

Esin Yesilalan in the Organogenesis Lab

Apligraf, produced in a Class 100 aseptic environment, traditionally employed 13 sterility tests throughout the 21-day process. In order to further drive the safety profile of the product, two additional bioburden sampling time points—a shorter test than the standard sterility test—were added to provide additional means to detect potential product contamination. This process change required validation and FDA approval, which came quickly as the team was adding additional quality control tests.

In another example, earlier this year, Organogenesis developed an automated processing station for Apligraf, to ensure greater consistency and aseptic control in the process. “We reviewed our existing manufacturing process, and applied the principles to the equipment design to meet all of the challenges in standard processing,” says Ted Donahue, Manager of Process Automation, “This was a custom-built system, and in our application to the FDA we were able to communicate the design of the equipment, the intents of the equipment, and display that it was operating within manufacturing processing parameters.” The FDA approved the process change within 90 days and it is currently in the process of being implemented at Organogenesis.

All for One

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 to stop it, to speak out if they see something that might be a concern.”

“We handle every single unit with care, and every unit is 100% inspected,” says Abraham-Freel. “There are many steps of the process. And that's how we guarantee that we have a high-quality, safe product.”

What also distinguishes the Apligraf team is its communication. The group is always having meetings—sometimes scheduled, sometimes not, sometimes ad hoc within the process. It has been critical that every aspect of the manufacturing process be thoroughly defined and discussed. “I think that's really what stands apart from what happens at other companies,” says Nolan. “This team is very, very unique.”