Lab Manager spoke to Douglas Schmid, PhD, about Predictive Biotech’s Laboratory at Research Park on the University of Utah campus in Salt Lake City. Douglas is chief scientific officer of Predictive Biotech, where he oversees laboratory operations, manages the production of human cells, tissues, and cellular and tissue-based products (HCT/Ps), in addition to inventory tracking and distribution, ensuring that all products meet FDA regulations. Douglas has over two decades of experience in biotechnology and has contributed to more than 20 scientific manuscripts and presentations.
The renovated FDA-registered laboratory is 42,000 square feet, and the renovation was completed in March 2019.
Q: What was the need for this facility? Is it replacing an outdated existing facility or accommodating new research/ a new program?
A: The idea behind the new laboratory was to create a state-of-the-art production facility and research and development (R&D) space for Predictive Biotech, a leader in regenerative medicine with products derived from tissue sources that are rich in properties that support the body’s natural ability to heal itself. We were faced with a need to scale our production to meet the demand and wanted to do so in the most sterile and technologically advanced space possible. This new space allows us to increase production and optimize conditions for product development, creating a more consistent, safe and high-quality product.
Q: What kinds of sustainability initiatives have been included in the design plan? Is the facility pursuing LEED certification or something similar?
A: Predictive Biotech is very aware of its carbon footprint on the environment and in our local community and we are constantly looking to implement eco-friendly practices. We are moving all records to electronic storage and utilizing electronic communication for correspondence. We choose vendors who provide environmentally safe products and enlist companies that handle laboratory waste in an eco-friendly manner, and we have recently begun a recycling program for all paper used in our offices and laboratory space. We are also looking for ways that we can reduce waste generated in our manufacturing process and for ways to reduce the amount of water used in cleaning. At present, although we feel that this is a very important issue, we have no plans to pursue certification.
Q: Is there anything particularly unique or ground-breaking about your facility or the design plan?
A: Predictive Biotech’s laboratory is unique in the field of human cell and tissue product development as it features an International Organization for Standardization (ISO) 7 cleanroom and 18 ISO 5 production hoods. The laboratory also recently passed the ISO-13485 audit, which means that we successfully established and implemented a world-class approach to the design, development, manufacturing, distribution, and servicing of our products. That certification alone should give you an idea of the steps we have taken to elevate our laboratory in order to provide the highest quality product and safety levels that no one else has. In addition to this certification, the laboratory also meets Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) requirements.
Q: What sorts of challenges did you encounter during the design/build process, and how did you overcome them?
A: The two biggest challenges were: 1) building a cleanroom with glass walls for full visibility from the outside while still maintaining a sealed, clean environment; and 2) ensuring that we could reach and maintain sufficient air exchange in such a large space. Luckily, our engineering firm and contractors had experience with similar spaces and had the expertise to build these spaces to our requirements.
Q: If a similar facility or program were to look at your lab for inspiration, what do you think they will take away as an example of what they should also implement in their own lab?
A: I think that if a similar facility or program looked at Predictive Biotech’s laboratory, they would take away the importance of not just meeting, but exceeding FDA and other safety standards for laboratories and R&D facilities, especially in the production of human cell and tissue products. The environment where a product is created is just as, if not more, important as the product itself. If companies do not have high standards for their facilities, how can they have high standards for their products?