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Cryogenics is the study and production of low temperatures
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Cleaning Validation for biotechnological substances : What acceptance criteria ?
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“Health-based approach” implementation for setting limits in cleaning validation for Vaccines/Biotech
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Low Endotoxin Recovery (LER) is today one of authorities serious concerns regarding pyrogen testing
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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Single Use & Stainless Steel: complementarity or fight?
There has been a huge increase in single use apparatus in the biopharmaceutical manufacturing world during the last. Many companies compete in manufacturing production tools. At Boccard where our mantra is “In Stainless Steel We Trust”, we have a different opinion. We believe that plastic and stainless steel are complementary. Let’s take the example of cell culture. Before growing in a huge fermenter (e.g. 1000 L), what is the point of using a stainless steel 20 L fermenter as a first step from an economical point of view? why not use Single Use apparatus in this case?
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Expansion of Human Bone Marrow-Derived Mesenchymal Stem Cells in BioBLU 0.3c Single-Use Bioreactors
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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Qualification approach for the validation of real-word shipping in single-use systems
The complexity of biopharmaceutical manufacturing processes requires continuous improvement. As shown in figure 1, the expansion of manufacturing capacity worldwide has resulted in the multiplication of links between production facilities as well as the increasing need for storage or transportation of media, intermediate, BDS, and drug products between sites over the world.
Outsourcing to contract manufacturing organizations (CMOs) offers a solution to the capacity constraints and reduces the total risks associated with building internal capacity; however, a robust and validated manufacturing process (2), including product transportation between facilities, is then required.
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Improving Single Use Bioreactor Design and Process Development. New Research Towards Intensifying Seed- Train & Scale-up Methods Using 5:1 Turn- Down
Immense pressure is being applied to improve process knowledge and execution for those working in the field of bio-therapeutic manufacturing. Bioprocess developers are being tasked to provide more product yield at lower production cost, to decrease the time required to bring new therapies to the patient, and to consistently manage operational risks.
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“Close Collaboration Maximizes Value of Engineered Solutions and Saves Time in Start-Up” The case study of BioMarin Fast-Track project with Verdot Ips²
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.