We apologize your item could not be found. Not all items are listed on our website. Please contact your account manager for details regarding your searched item.
Material number (eg: xxxxxxxxxxx) no space or hyphen needed.
No Results Found
There is increasing demand for advanced manufacturing technologies for fill-finish operations of parenteral drug products. To meet manufacturing requirements for multiple container and component types, flexible fill-finish equipment is at the forefront of most pharmaceutical, biotech, and CDMOs’ fill-finish strategy. Flexible fill-finish technology is suitable for variable batch sizes allowing for scaling from clinical to commercial in multiple drug delivery presentations. With the ability to launch in vial configurations, prefilled syringes, or other combination products including devices, flexible fillers are beneficial to drug developers who are looking for lifecycle management of their drug products.
Filling and plunger placement of nested pre-fillable syringes as they reside in their nest. Image courtesy of Bausch+Ströbel. Used with permission.
However, not all fill-finish original equipment manufacturers (OEM) are the same. Building or expanding manufacturing capabilities requires multiple factors that need to be evaluated: maximization of floorspace, reducing risk of cross-contamination, manufacturing flexibility, varying throughput, tech transfer, and various primary packaging formats. Further, to ensure that an investment in flexible fill-finish equipment meets long-term needs, there are some critical aspects that need to be considered upfront.
Some key considerations that need to be taken into account when selecting flexible fillers include:
The recently revised EU GMP Annex 1, Manufacture of Sterile Medicinal Products1 guideline advises that the introduction of materials into the clean room or filler is one of the single greatest sources of contamination. Therefore, careful selection of packaging configurations (i.e., nested trays, ported bags, steribags, or bulk components) based on the designated manufacturing facility and filler design is an important decision and must be considered as a design input to support Quality Risk Management (QRM) and Contamination Control Strategy (CCS) implementation. These aspects will determine of level of protection of drug product from contamination, cost of equipment as well as added operational costs, lifecycle management of drug into different packaging formats , and overall safety and efficiency of the manufacturing process.
When considering these critical details, choosing the right flexible fill-finish OEM may be a daunting task. West recognizes the importance of proactively working with flexible fill-finish OEMs during development of components to ensure compatibility of their equipment for proper handling, filling, and processing for intended use with our primary packaging systems. For customers with existing equipment, rather than requiring the fabrication of a new filling line or line addition, some parameterization, process tuning, or format part change-overs may be required so that primary packaging can be processed as intended. This can improve manufacturing readiness and help get customer closer to commercialization.
As you look to work with a CMO or build internally for your flexible fill-finish operations, West can help identify container closure solutions that will work with your manufacturing processes. To learn more about these fill-finish features, read our whitepaper here. For more information, visit our fill-finish page.
References
Overview of EU GMP Annex 1<br />EU GMP Annex 1 is the European Union’s guidelines for good manufacturing practice (GMP) of sterile medicinal products for human and veterinary use.<sup>1</sup> It provides specific requirements for the manufacture of sterile medicinal products, including principles for cleanroom and clean zone design, personnel experience/qualification, and monitoring of manufacturing environments, just to name a few. The objective is to ensure product quality and potency, as well as patient safety, by minimizing risks of microbial, particulate and endotoxin/pyrogen contamination through manufacturing and environmental controls.<br />In August 2022, the final draft of EU GMP Annex 1 was released after years of development and took effect on 25 August 2023. In this blog, a summary of the key changes of relevance to primary packaging components and how West can help with the implementation will be discussed.
Fill-Finish engineering and process development are a critical step to ensuring product quality and manufacturability for injectable products. Fill-Finish involves technique driven process steps with considerations around patient safety at the forefront of each step. The complexity of aseptic processing and sterile fill-finish operations will continue to grow as more complex drug products enter the pipeline.
The need for <a href="/sitecore/service/notfound.aspx?item=web%3a%7b8E02CCA4-F229-4EDC-93A4-6A837E7FA55E%7d%40en">advanced containment solutions</a>, and novel fill-finish processing to enable implementation of these solutions, continues to grow as more complex drug products enter multiple pipelines. As biotech companies develop these complex drug products, the integration of product and process knowledge is crucial to delivering product safety, quality, identity, potency, and purity. And as biotech companies seek partners to help accelerate their development processes, West is committed to leading multi-disciplined, high-performance teams in developing optimal fill-finish solutions for novel packaging and container systems. This dynamic partnership is well-illustrated by the following case study.
Cell-based therapies have emerged as a revolutionary approach in the field of regenerative medicine and as an anti-cancer therapeutic modality, offering potential treatments for a range of diseases. As the demand for cell-based therapies continues to grow, it is crucial to explore the current and future fill-finish packaging strategies to ensure the safety, efficacy, and accessibility of these therapies. Understanding the advantages and challenges associated with different modes for cell therapy packaging will allow drug manufacturers to choose a suitable system.
Packaging components are an integral part of a drug product. Selecting the right packaging system is not trivial--it can impact patients' health, operational efficiency, drug compatibility and drug stability. A good container closure system includes a glass or polymer vial, an elastomer stopper and an aluminum seal.
English
Chinese
