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The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.
SGS, a pharmaceutical, clinical, and bioanalytical contract solutions provider focused on early-stage development and biometrics, announced on Sept. 4, 2018 that it has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early phase clinical trials at its Clinical Pharmacology Unit (CPU) in Antwerp, Belgium to strengthen its offerings in the areas of infectious disease therapeutics and vaccines.
According to the company, demand in the biopharmaceutical industry for R&D in immunology and oncology therapeutics continues to grow, with additional parameters now required for clinical trials beyond traditional pharmacokinetic and pharmacodynamic parameters. In today’s research, collection and use of peripheral blood mononuclear cells has become a strategic and reliable analytical tool.
SGS reports that PBMCs are widely used to study various aspects of pathology and biology in vitro but are now also used more frequently in clinical studies in immunology (including auto-immune disorders), as well as infectious diseases, hematological malignancies, vaccine development, and transplant immunology. They are also used in high-throughput screening, neovascularization, human-body defense mechanism studies, and the analysis of biological effects on tissue and organs and chemokine effects on adipocytes and muscles.
The use of PBMCs within clinical trials poses significant operational challenges, as the cells demand intensive handling techniques. After isolation, the PBMCs must be cryopreserved immediately, and in addition, have a determined timeline to be handled because of viability and recovery issues.
"At SGS, we have been working on these specific cells and invested in the optimization of the process for their capture and handling. This involved the development of several new clinical processes to maintain high-quality samples and flexible pathways for the use of PBMCs," said Haiko Pillu, director of operations, CPU, SGS, in a company press release. “One of the processes to optimize the handling of PBMCs in early-phase trials is the use of the all-in-one cell preparation tubes, which, compared to the traditional Ficoll method, require less training of site staff, are less labor intensive, give better results in terms of viability and yield, and allow more time for the processing steps when conducting a clinical trial."