Aseptic Filling of Small Volumes with High Precision
Filling accuracy has become increasingly important for laboratories and biopharmaceutical manufacturers. Single Use Support has developed best-in-class filling precision for aliquoting small single-use bags with its RoSS.FILL aseptic filling platform.
Typically, the distribution of small volumes of advanced therapy medicinal products (ATMP) into small single-use bags was done manually. However, manual handling carries the risk of cross-contamination, overfilling, inconsistent cell counts, and, as a result, product loss.
RoSS.FILL Lab Scale is a fully automated cGMP-compliant aseptic filling technology for up to 12 small single-use bags of 10mL to 500mL. RoSS.FILL CGT, on the other hand, is specifically designed for cell and gene therapy manufacturing, able to fill from 36 up to 128 single-use bags with volumes between 1mL and 1000mL.
Single-use technology optimizes bag filling with fast, scalable, and accurate aliquoting. Single Use Support’s state-of-the-art small volume filling systems are specifically designed to support laboratories and pharma companies in accurately handling small fill volumes of biologics to advance fluid management processes through automation.
The role of aseptic filling of small volumes
Aseptic processing and filling of small volumes is an increasingly frequent task in the biopharmaceutical industry. One reason is a major shift in healthcare towards personalized medication, where therapeutics are customized for few individuals, if not for one single patient. This approach has led to huge progress in the fight against medical conditions like cancer or autoimmune disorders. However, accessibility and costs pose challenges for the pharmaceutical industry as well as for healthcare providers.
This is because – in contrast to large-volume production – low-volume drug manufacturing may require more resources due to the high degree of customization. Therefore, while there are large-scale vaccines that hardly cost more than the syringe used for their injection, minute vials of personalized injectables may come with considerably higher price tags.
But also before these innovations in the field of advanced therapies, the life sciences sector had been relying on precise fill-finish processes of biologics on a smaller level. In research, drug discovery and development, for instance, smaller units are dealt with. Nevertheless, trials, testing and case studies have to prove successful before an eventual aseptic manufacturing process, including respective GMP filling lines, is initiated. Nonetheless, cleanroom and regulatory requirements (e. g. issued by the FDA) need to be addressed even in early stages.
These two sectors – personalized medicine as well as research and development in biopharma – are consequently in need of bioprocess platforms that can cope with aseptic filling of minute volumes without compromising in precision or safety.
Read more: Aseptic filling of large volumes
High Precision Filling
Single Use Support offers best-in-class fluid management solutions for volumes as little as 3mL. With a filling accuracy of ±5% for volumes ranging from 20mL to 50mL and a filling accuracy of ±2% from 50mL upwards, the globally operating process solution provider enters new realms of automated filling accuracy for biopharmaceuticals. By complying with 21 CFR Part 11, the automated aliquoting system for single-use bags replaces manual documentation.
Advanced sealer pinch valves can be optionally integrated into any of the modular RoSS.FILL platforms. With variable fluid control to accelerate throughput and facilitate fast filling as well as simple aseptic decoupling of single-use bags, these valves significantly improve the fluid management process. Single Use Support’s modular and vendor-independent process solutions for sterile filling–draining, freezing–thawing in addition to their protective solutions that cover the entire storage and shipment process further optimize the fluid management of high-value liquid drug substances.
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Filling & Filtration for Small Volumes (1mL-1000mL)
Single Use Support’s small volume filling systems help laboratories and manufacturers aliquot volumes from 1mL to 1000mL and scale up to 72+ single-use bags. |
