![]() ![]() A separate isolator is used in the filling suite for automated fill/finish of the vials. Glove ports allow operators to perform manual process steps in the isolator. In each the facility’s two manufacturing suites, a custom designed, four-chamber isolator encloses all parts of the UCART manufacturing process. Use of a Grade A isolator is known by regulators and the industry as the lowest level of risk to sterility, he adds.Ĭellectis, for example, is a gene-editing company that recently opened a facility where it is performing clinical-stage manufacturing of allogeneic, universal chimeric antigen receptor T-cell (UCART) immunotherapies. Inquiries into isolator technology for ATMPs have been increasing, says Pridden, primarily because of the higher level of safety and the need to meet the requirements of Annex 1. The lower cleanroom levels require less personal protective equipment (PPE), which is more comfortable for operators as well as saving in costs and environmental impact of PPE disposal, explains Matt Pridden, standard product development manager at Extract Technology. Another advantage of using an isolator are that they can be used in a Grade C or D cleanroom, which requires less capital expenditure and lower energy use. Isolators, however, are closed systems that reduce contamination risk. Biosafety cabinets have lower initial capital costs, but they present higher risk of microbial or cross-contamination and must be used in a Grade B cleanroom. ![]() While these small-volume processes started out primarily as manual processes in biosafety cabinets, new equipment offers the option of closed and automated processing. Innovative isolator equipment is being developed and used in cell and gene therapy (CGT) manufacturing, as more companies get involved in the emerging area of advanced therapy medicinal products (ATMPs). This system, which is being developed in partnership with Vetter, is planned to be launched in 2022 (3). Syntegon’s Versynta microBatch is an automated production cell in a gloveless isolator for smaller batches in the range of 120–500 containers per hour. ![]() The isolator’s air flow is optimized so first air is supplied to the containers without obstruction. It uses a four-axis robot inside the isolator to handle containers for filling aseptic or highly potent liquid products and can fill up to 3600 containers per hour (4). Syntegon introduced the modular, small-batch Versynta FFP in 2021. Robotic automation is beneficial for small batches because it allows flexibility and more rapid changeover (3). The automated system offers flexibility with individually controlled shuttles, which increases throughput while while using a less complex and smaller footprint than traditional automation systems.Īlthough isolators have been commonly used in larger-scale or automated aseptic fill/finish, the technology is pushing into smaller-volume areas. Comecer, an ATS company, displayed a containment isolator integrated with the company’s new automated SuperTrak Pharma platform for asynchronous conveyance at INTERPHEX 2021. Automation inside isolatorsĪutomation inside isolators further reduces human intervention. Evaluating the design of the isolator system in relation to the contamination control strategy is crucial, explained Richard Denk, a senior consultant for Aseptic Processing and Containment at SKAN (1). The draft revision to the European Union’s Annex 1 good manufacturing practices (GMP) for manufacturing sterile medicinal products (2) provides direction for designing and cleaning isolators (1). Isolators operate as closed systems and can be designed with attached gloves for manual intervention or as “gloveless” for fully automated systems. The use of isolators for aseptic manufacturing has increased, driven by the effectiveness of the equipment for product safety and by the increasing number of products that must be processed aseptically (1). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |