“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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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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Design of a production isolator. From user need to construction.
La Vague 52

Design of a production isolator. From user need to construction.

It is an absolute truth that all sterile production line installations must be associated with an appropriate means of protection of the product and the environment. When this choice relates to isolator technology, very particular attention must be paid to its design. This must be based on a perfect match between user need and the current state-of-the-art of this cutting-edge technology, culminating in an optimised solution for future production. The installation of a new injectables production line at the Aspen site at Notre-Dame-de-Bondeville (76) is an example. The site, located in Normandy close to Rouen, has specialised in the production of prefilled syringes for many years and produces almost 118 million syringes each year destined for more than 30 international markets including the USA.

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The European approach to disinfectant qualification.
La Vague 52

The European approach to disinfectant qualification.

Contamination control is of great importance to healthcare facilities and to pharmaceutical cleanrooms. One way of ensuring the hygiene is maintained through a cleaning and disinfection regime. After a disinfectant has been chosen based on its chemical properties and expected performance/effectiveness, each disinfectant should be validated to ensure its efficacy.

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Advanced vaporized H2O2 decontamination technology for pharmaceutical isolators. Reduction of H2O2 decontamination cycle time using direct injection nozzles.
La Vague 52

Advanced vaporized H2O2 decontamination technology for pharmaceutical isolators. Reduction of H2O2 decontamination cycle time using direct injection nozzles.

For the purpose of protecting pharmaceuticals from contamination with microbes or nonviable particles filling and closing machinery are equipped with isolators or other barrier systems. It is not only the Sterility Assurance Level (SAL) which is focused upon but also the non-productive time for decontamination processes between batches which has to be taken into account.
This article describes and evaluates a new technology to reduce the cycle time of isolators.

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