LABS, Inc., a global, full-service testing laboratory with more than 30 years of expertise in regulated testing for human organs, cells, tissues and implantable biologic products and devices, has launched a group of new laboratory tests suitable for screening complex biologic products. These new offerings will allow the company to provide innovative solutions with faster turnaround times to meet the needs of existing and future clients.

“The medical and scientific industries are creating products that do not readily conform to the legacy compendial assays. As such, LABS is committed to taking a leadership role to provide alternative solutions for these complex biologic products, which often require faster test results from smaller sample volumes,” said Chad Ronholdt, vice president Strategic Development of LABS, Inc.

LABS this month launches five new tests:

Novartis Procleix Tigris System: a new, fully automated Nucleic Acid Testing (NAT) platform for infectious disease screening. NAT is the gold standard to detect HIV-1, Hepatitis B and Hepatitis C viruses for the purposes of human organ, eye, cell and tissue donor eligibility screening. LABS is the only complex biologic testing facility in North America to offer this new, superior platform. The automated platform minimizes operator-induced variability and allows LABS to capitalize on efficiencies that the older, manual donor eligibility methods cannot offer.

MYcoSEQ Mycoplasma Real-Time Polymerase Chain Reaction (RT-PCR) Detection Assay: a robust, reliable and efficient method for detecting more than 90 species of Mycoplasma contamination within seven days. This new assay, independently validated by LABS, is ideal for the evaluation of upstream and mid-stream processing samples during the manufacturing of human biologic and cellular-based products and/or reagents. The assay is not intended to be used for final lot release unless a secondary validation is performed and incorporated into a regulatory product application.

VDmax sterilization and dose audits: a simplified validation method for sterilizing human allograft products such as bone, osteobiologic putties and soft tissues comprised of ligaments and tendons, through the use of radiation. This method is also very useful for the validation of associated materials used during the processing of allograft products such as packaging, syringes, sample containers, etc. Upon successful completion of the validation, quarterly dose audits are performed to confirm that the sterilization dose initially determined for the product is still appropriate over time.

Blood spot and buccal swab Human Leukocyte Antigen (HLA) analysis: a simplified method, requiring lower sample volume, for collecting DNA samples for HLA typing, which is used to match donors and recipients for cell-based transplants and transfusions. These new methods are particularly valuable in situations when whole blood samples are scarce or unavailable.  The blood spot method uses a single drop of blood applied to an FTA card, which contains a proprietary formula to capture and preserve the blood sample for testing. The buccal swab method doesn't rely on the availability of blood to collect the required DNA for analysis, instead using a sterile swab to collect cells containing DNA from the inside of a cheek.

Endotoxin testing: endotoxins are toxic substances derived from gram negative bacteria and can be associated with biologics, biopharmaceuticals, medical devices, packaging materials and water purification systems. Complex biologic products present a formidable challenge to the standard endotoxin instruments and testing methods since there is typically an inherent level of inhibitory substances present within them. LABS has extensive experience with mitigating these inhibitory factors, which will give clients accurate, reliable and rapid results for screening and/or lot release of biopharmaceuticals, complex biologic products or medical device products or packaging.

“We are proud to be at the forefront of developing and implementing cutting-edge testing solutions to meet the rapidly evolving biologic landscape, particularly for industries like biopharmaceuticals, cellular therapies, regenerative medicine and tissue engineering products,” said Elizabeth Hearty, chief executive officer of LABS, Inc.

LABS is the leading donor eligibility testing laboratory in the nation. The Company obtained this industry leadership position in the donation community by providing highly customized solutions using the most innovative technologies, delivering precise results, and maintaining an unmatched attention to customer service and quality. As an FDA registered, ISO, CLIA and CAP certified testing laboratory, LABS clients' samples are handled and processed with the most reproducible and reliable methods available. Additionally, LABS is uniquely capable of delivering highly complex and customized solutions to clients creating a variety of rapidly evolving complex biologics.