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 (PK) and pharmacodynamic (PD) parameters. In today’s research, collection and use of peripheral blood mononuclear cells (PBMC) has become a strategic and reliable analytical tool.
PBMCs are already widely used to study various aspects of pathology and biology in vitro, but are now also more and more used 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 due to 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," commented Haiko Pillu, Director Operations, CPU, SGS. He added, "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."
SGS's Clinical Pharmacology Director, Annick van Riel, continued, "Our expertise in using this technique, combined with our capability to manage such a sensitive parameter in our early phase clinical operations, complete the infectious diseases and vaccines service offer that we have built up over many years, including our CPU Human challenge unit."
SGS provides clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in the America, SGS offers clinical trial (phase I to IV) services encompassing drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling and simulation, and regulatory and medical affairs services. SGS has its own Clinical Pharmacology Unit in Belgium, including a human challenge testing facility and two phase I patient units based in Belgium and Hungary. SGS has a wealth of expertise in First-In-Human studies, viral challenge testing, biosimilars and complex PK/PD studies, with a therapeutic focus on infectious diseases, vaccines and respiratory.
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