Spring cleaning in microns / Europe's second largest cord blood bank cleans labs / cell bank transformation started
There are few companies that have to protect their product from their own employees. However, that is exactly the case with the Vita 34 umbilical cord blood bank. Because at the DACH market leader for the storage of stem cells from the umbilical cord it is immensely important that the preparations are not contaminated. However, since humans are the greatest carriers of germs, the company also has the special ones once a year in addition to the cleaning that takes place several times a day clean rooms of the laboratory are cleaned by a highly specialized company. You could say spring cleaning. But the process is far more complex. It's about the smallest particles in the micrometer range. Cleaning and disinfecting down to the tiniest corners is carried out according to strict international standards and guidelines in order to be able to offer customers the demanding manufacturing processes for many decades to come.
Cleaning the highly sensitive clean rooms in the laboratory is a logistical tour de force. "During non-operational times, the specialist company we commissioned has to clean around 200 square meters of space perfectly within a time window of eight to ten hours. This includes not only the floor, but also the ceilings and walls. The goal is three-dimensional cleanliness, so to speak," explains Dr. Mario Lehmann, head of production at Vita 34. Nicolett Schumann, deputy head of the laboratory, adds: "To make this possible, you need specially trained specialists who work in an absolutely sterile manner with complete protective clothing - suit, hood, face mask and gloves. With special equipment, the clean rooms, the devices and even the ventilation systems are first freed from disinfectant, then cleaned and then disinfected again. This is the only way to guarantee almost perfect purity and protect our product in the best possible way. The costs for this are in the high four-digit range.”
The entire area that the valuable umbilical cord blood travels from delivery to freezing at around -180 degrees in the cryogenic storage facility is cleaned. In this sensitive area of drug manufacturing, purity is scientifically defined and even measurable. A so-called clean room monitoring takes place with high-performance measuring devices, the particles in the air are recorded precisely. In class A clean rooms – as is the case with Vita 34 – only 20 particles with a maximum size of 5000ths of a millimeter per cubic meter of air may be detectable.
The focus on the smallest details is not only in the DNA of Vita 34 when it comes to cleaning the clean rooms, but will also play a major role in the future development of the company. Because with the forthcoming expansion of the business area, the transformation to a cell bank has started. With the planned introduction of the storage of the body's own fatty tissue and the stem cells it contains, as well as the planned expansion of the product range by the cryopreservation of immune cells from peripheral blood and umbilical cord blood, the course has been set for further market potential. The range of products from Vita 34 is then no longer just aimed at expectant parents, but at people of all ages.
On March 1, 2020, a new research project started at the Fraunhofer Institute for Cell Therapy and Immunology IZI. Imaging of living cells is to be improved with the help of viral and bacterial targeting sequences. The project is funded by the Volkswagen Foundation.
On February 17.02.2020th, 2018, the new working group "Cell Therapies" of the innovation cluster Smart Medical Devices and Therapies from biosaxony started in Leipzig. Cell therapies, for example based on CAR-T cells or natural killer cells, are primarily researched and developed at the Dresden and Leipzig sites. The manufacture of the Novartis product Kymriah®, which was approved in XNUMX, is based, for example, on work by the Leipzig Fraunhofer Institute for Cell Therapy and Immunology (IZI). With the combined expertise of both locations, an application was submitted with "SaxoCell" as part of the future cluster initiative of the Federal Ministry of Education and Research, which recently successfully started the second round of the competition. The two main applicants, the Center for Regenerative Therapies in Dresden and the Fraunhofer IZI, were also part of the first meeting of the working group, as was the Biotechnological-Biomedical Center of the University of Leipzig.