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?
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)
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.
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.
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.
Cahier Pratique - Essais de stérilité sous-isolateur - Qualification de performance et optimisation des plans de charge (La Vague 52)
La réalisation des essais de stérilité sous isolateur représente la méthode recommandée la plus fiable pour conduire ces essais en toute sécurité et limiter le risque de résultats faux positifs avec toutes les conséquences liées à cette situation.L’isolateur est donc l’outil à privilégier chaque fois que possible pour maîtriser la qualité des essais de stérilité.