Expansion of Human Bone Marrow-Derived Mesenchymal Stem Cells in BioBLU 0.3c Single-Use Bioreactors (La Vague 53)

Mesenchymal stem cells (MSCs) are attractive candidates for therapeutic applications, especially in the field of regenerative medicine [1] because – in contrast to embryonic stem cells – they do not pose ethical issues, they can be isolated from various tissue sources, and they reduce the risk of rejection reactions. The doses of human MSCs (hMSCs) needed for clinical trials are estimated at between one and 200 million cells per patient, depending on the disease being tackled [2]. One of the most important challenges in providing hMSCs for curative use is the production of large quantities of cells in a robust manner.

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Moving One Unit Operation At a Time Toward Continuous Biomanufacturing (La Vague 53)

Many industries including those associated with generation of power and the manufacture of glass, steel and petrochemicals etc. have demonstrated that continuous manufacturing provides significant benefits and advantages, ranging from reduced capital and operating expenses to greater efficiency and product quality and consistency.

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Frontière Part I/ Part II des BPF : Modalités d’application aux produits biologiques (La Vague 53)

Suite aux questionnements des Entreprises Françaises de Biotechnologie sur la segmentation proposée par les inspecteurs des parties I et II des BPF vis-à-vis du procédé de production des médicaments biologiques, cet article a pour objectif de proposer une clarification argumentée du cas particulier de ces substances actives biologiques dont la formulation est réalisée lors de la production de substance active et non au moment de la fabrication du produit fini. Ce principe s’applique pleinement aux protéines recombinantes et anticorps monoclonaux, et au cas par cas des procédés de fabrication, pour d’autres types de médicaments de biotechnologie et thérapeutiques innovantes (vecteurs de thérapie génique et vaccins, ...).

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"Close Collaboration Maximizes Value of Engineered Solutions and Saves Time in Start-Up" (La Vague 53)

The case study of BioMarin Fast-Track project with Verdot Ips²

This paper reports a very fruitful collaboration between a Biopharmaceutical company, BioMarin International Ltd and a manufacturer of purification equipment, VERDOT Ips², which contributed to a fast start-up of an installation for manufacturing a recombinant human tripeptidyl peptidase 1 (rhTPP1), for the treatment of neuronal ceroid lipofuscinosis Type 2 (CLN2) disease, also known as Batten Disease.

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Low Endotoxin Recovery (LER) is today one of authorities serious concerns regarding pyrogen testing (La Vague 53)

Low Endotoxin Recovery (LER), initially described by Chen and Vinther in 2013, is a phenomenon occurring in protein formulations that is characterized by efficient masking of Lipopolysaccharides (LPS/endotoxin). Depending on the protein - buffer characteristics, the temperature - and time - dependent masking effect can lead to complete non-detectability of LPS, which might present a serious risk for the patient. At first being interpreted as a purely artefactual event occurring in testing laboratories, LER is today one of FDAs serious concerns regarding pyrogen testing.

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