The LifebankUSA™ Facility and Procedures TourWhen it comes to placental stem cell and cord blood storage, you can
take confidence in LifebankUSA. LifebankUSA is a division of Celgene®
Corporation, a leading, publicly owned, multibillion dollar biopharmaceutical
corporation headquartered in Summit, NJ. LifebankUSA’s facilities are
specifically designed to process, store, and release both placenta-derived and
cord blood stem cells while meeting the highest facility and procedural standards.
That makes cord blood storage and our new offering of placenta stem cell storage
a worry-free decision for you. Arrival of Your KitWhen your LifebankUSA collection kit arrives at one of our facilities, it is immediately treated with the highest priority and utmost care. Before your collection kit is brought into our lab, the cord blood and placenta in your kit are individually matched to your account using our precise barcoding and computer systems. That added level of security is important, not only to our process, but also for our customers’ confidence. All paperwork is carefully checked, including the maternal and family medical histories and the donor delivery record. We adhere to a closely controlled and proven system for recording all information and transporting your baby’s placenta and cord blood into the laboratory for processing and storage. In compliance with regulations, a sample of the mother’s blood is tested for specific transmissible disease markers. And, you can take comfort knowing we have our process down to an exact science—we receive placental and cord blood kits 7 days a week, 365 days a year, and treat each with the same high standards. Our FacilityThe LifebankUSA facilities are designed to exceed your expectations. All of our equipment is state of the art and conforms to the highest standards, meeting all current Good Tissue Practices (cGTP). Current Good Tissue Practices (cGTP) ensure that there are procedures in place, which govern the safety and quality of our products and services. Our Quality System sets standards for monitoring equipment, air quality and particle counts, so that the integrity of the placenta-derived and cord blood stem cells, which you have entrusted to us, is not compromised. Because LifebankUSA is a research-oriented organization and sometimesoffers public banking services for cord blood storage, we are required to keep the most up-to-date, cutting-edge facilities. LifebankUSA has a long history of successful stem-cell storage and has released cells for transplant all over the world. Most notably, a 6-month-old boy with leukemia had stem cells donated by his sister and has been disease free for more than 3 years after the transplant. Another LifebankUSA success story is a 10-year-old girl with myelodysplastic syndrome (a disease of bone marrow similar to leukemia) who received a stem cell transplant and is doing well and in complete remission for more than 1 year after the transplant. You can also take confidence in the fact that LifebankUSA is actively and
uniquely involved in research associated with stem cells and is always
learning of new applications for the placental and cord blood you store with
us. So, we update our facilities to keep on top of the latest developments
and requirements. We adhere to a rigorous level of self-imposed standardization—
every step of our process is verified, validated, and certified. And, as part of the
world-renowned biopharmaceutical corporation, Celgene, we accept no substitutions
for the carefully chosen products and tools we use at LifebankUSA. Processing Your Baby’s Umbilical Cord BloodOnce the cord blood you store with us is identified and screened, it is taken to the laboratory where we extract the stem cells for storage and future release. Our laboratory facilities and our standardized processes of the highest quality ensure that your investment is in the best hands possible. Unlike other approaches to processing cord blood, we collect and process your baby’s stem cells in a completely closed system. This means that the collection bag in which your baby’s cord blood leaves the hospital is the same collection bag in which it will be processed. Through specialized equipment for use with our storage bags, we are able to transfer the umbilical cord blood cells into the cryogenic (freezing) bag and do all testing and processing in this closed system. This unique approach guarantees the most sterile conditions possible for the processing and storage of your baby’s cord blood. When it comes to the science of extracting your baby’s precious stem cells, LifebankUSA is second to none. We utilize a technologically sophisticated process for separating your baby’s precious stem cells from the other cells in the cord blood. And, you can take comfort knowing we use FDA-approved and USP-grade (an independent agency that sets standards for pharmaceutical products) products to perform this process. Before storage of your baby’s cord blood stem cells, we test the unit for: Processing Your Baby’s PlacentaWhen it comes to banking your baby’s placental stem cells, LifebankUSA is the world leader. LifebankUSA is the first and only company to take the intact placenta and process it to collect the valuable stem cells it contains. The placenta is processed in an individual clean room for maximum sterility and security. We work with one placenta at a time in an isolated, specialized laboratory to avoid any risk of cross-contamination and to eliminate error. And, because we begin with the intact placenta, we have the ability to retrieve the most stem cells possible. We also do not require your doctor to do any procedures or cutting of the placenta. We are the placental stem cell experts—we receive the intact placenta and take it from there, which is best for you, your family, and your doctor. All placental stem cells undergo the same thorough cell testing as cord blood cells. Freezing Your Baby’s Stored CellsWhen it comes to cryogenically storing (freezing) your baby’s stem cells, LifebankUSA applies the latest scientific learning and technology to ensure success. Unlike many other banks, we implement “control-rate freezing.” This means that we strictly control the rate at which the temperature of the cells is lowered so that they don’t get too cold too rapidly. The benefit of this is that it maintains the integrity of the cells you store—so if and when you need the cells for therapeutic use down the line they are healthy, usable, and have the greatest chance for engraftment. First, we place the storage contents into a specialized short-term freezer to regulate the temperature at which the cells become frozen. Only after your baby’s cells are safely and gradually brought down to the optimal temperature do we move them to the long-term storage area. LifebankUSA stores your baby’s stem cells for the long term, using the latest, most advanced storage technology available. Each unit is uniquely identified, then placed into a sealed and well-protected storage cartridge . The storage cassette is then placed into a rack, which holds multiple cassettes, and placed into a cryogenic storage tank. This sophistically organized and technologically advanced system allows us to easily locate and identify all stored cells for future use. Whereas many other stem cell banks use liquid nitrogen, LifebankUSA uses a special Vapor-Phase cryogenic process. This means that the individual storage units are never submerged fully into liquid nitrogen, but are rather suspended just above the liquid. The advantage of this approach is that it rules out any possibility—however unlikely—of cross-contamination of stored stem cell units through the liquid. The temperature in the storage tank is an astounding –190° centigrade—that’s –310° Fahrenheit! When you store stem cells with LifebankUSA you can be confident knowing that our state-of-the-art
central monitoring system protects the units and facility 24 hours a day, 7 days a week, 365 days a
year! We have backup power generators in case of any power outages, and also maintain a battery backup
system to back up the generators.
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LifebankUSA™, A Celgene Company. Copyright © 2007
