La Vague 53

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
La Vague 53

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
La Vague 53

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
La Vague 53

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
La Vague 53

“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.

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

Moving One Unit Operation At a Time Toward Continuous Biomanufacturing

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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Limit between GMP Part I/ Part II : Applicability to biological products
La Vague 53

Limit between GMP Part I/ Part II : Applicability to biological products

Following to questions raised by French Biotech industry on GMP part I and II cleavage proposed by inspectors regarding biological production process, the objective of this article is to propose a clarification in the particular case of biological active ingredients when formulation is performed during Drug Substance manufacturing instead of during Drug Product manufacturing.
This apply fully to recombinant proteins and monoclonal antibodies and case by case to other biotechnology manufacturing processes and innovative therapeutic (vectors of gene therapy and vaccines,…)

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FILAB
Company directory

FILAB

FILAB is an independent laboratory providing analytical services such as chemical analysis, analytical development, and powders characterization.

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Secure the containment of your gloves
La Vague 52

Secure the containment of your gloves

There are two types of gloves for isolators and other containment systems:
• so-called ‘one piece’ gloves which extend from the glove port from the shoulder to the finger tips
• so-called ‘glove-arm guard’ gloves which consist of an arm-guard extending from the glove port from the shoulder to the cuff ring then a glove extending from this ring to the fingertips.
This last type of assembly allows for glove replacement where a different glove size is needed or in the event of accidental perforation.

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