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Leading BioTech CompanyBackgroundSince 1993 this leading BioTech company processes umbilical cords and acts as a stem cell blood banking center. Their role is to receive cord blood and expeditiously prepare and process the blood before cryogenically freezing it in temperatures in excess of -184 degrees Celsius. The timely processing of cord blood (or stem cells) is critical in order to maintain maximum viability (or cell count) prior to freezing and preserving the blood for potential future use in transplants or otherwise. The parent company headquartered in Boston, Massachusetts is a cutting edge stem cell research firm with leading studies designed for cellular therapy. Their trademark is the process of selective amplification of the repopulating stem cells. Umbilical cord stem cells are today a part of therapy regimen for 50 diseases. The revenue-generating arm of the research firm is located in Hebron, Kentucky and has projected annual sales revenue of $27-30 million dollars. They employ approximately 35 people in Kentucky and process all patient cords from around the world at this facility. After gaining approval from the FDA for stem cell (umbilical cord) blood banking procedure, this company needed to establish and improve their process modeled in large part like existing traditional blood banks. After doing so, the popularity of banking stem cells began to grow and so the challenge was to improve the existing process and prepare for the expected increase in interest and volume. The ProblemWithout internal resources and expertise this company commissioned Synergetics to help improve processes in both the preparation area and processing laboratory. This was mandatory to enable the expected 5% monthly growth and simultaneously reduce variable costs. Capital investment and plant expansion is inevitable however, management intuitively realized that there was plenty of opportunity to increase the utilization of current resources and optimize a relatively immature process. Scope and AssignmentSynergetics was asked to look at operations including Prep/Setup, Processing (lab) and Freeze areas for quality, cycle time and productivity improvements throughout. The existing team of professionals were overwhelmed with the regulatory requirements; primarily manual documentation, and needed rethink the value added nature of all procedures. The project focused in the following areas:
The Results
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Synergetics Installations Worldwide, Inc. 75 Congress Street, Suite 201 Franklin Block Building Portsmouth, New Hampshire 03801 (603) 433-8940 | |||