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.
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,…)
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.
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.
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.
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.
What performance requirements are needed for analytical procedures to ensure an alignment with the enhanced approach of Quality by Design for product/process? An analytical procedure should be followed during the life cycle of the product to continually assure that it remains fit for its intended purpose.
A platform process is a production process suitable for the manufacture of a group of related products in a defined production system. At Lonza one of our technology offerings is a platform process for the production of therapeutic proteins in Chinese hamster ovary (CHO) cells.
The techniques available for the microbiological monitoring of products and manufacturing environments have come a long way in the last few decades. Even though enumerating microbial cells by counting colonies on an agar filled Petri dish is still a common technique, a variety of more sophisticated and rapid methods are making their way into the quality control microbiology laboratory. These Rapid Microbiological Methods (RMM) exploit chemical and physical methods developed to elucidate the structure of cell components and the functions of biomolecules. These methods are then applied to the detection, enumeration, and identification of microorganisms that may be present in pharmaceutical, food and beverage, water and other samples submitted to the quality control labs. Thus, the simple view of a bacterial cell as a tiny living entity so small as to be invisible to the naked eye, and countable only by either microscopy or culture, is changing to a much more complex picture encompassing the most intimate details of the cell structure and the biomolecules that form it.