Thursday, March 28, 2024
April 24, 2023
The safe handling of ADCs or other HPAPIs is a complex and elaborate process that requires specialized facilities and a safe, sterile environment.
The filling/aliquoting step in particular calls for great care and specific equipment to ensure sterility and rule out any potential cross-contamination as well as potential harm to handling staff. After all, most ADCs contain extremely active cytotoxic molecules, making process safety in fluid management a top priority for biopharmaceutical manufacturers as well as CMOs.
With growth rates expected to remain in the billions, it pays off to put into place and invest in technologies that facilitate automated and scalable filling/aliquoting processes, that are safe and sterile.
Considering the complexity levels of antibody-drug conjugation, any advances made to improve or simplify the process are welcome news in the world of biopharma.
Single-use systems are closed systems that ensure the most important aspect in ADC processing - Safety. Even better if those advances come with the added benefits of being able to reduce costs and add to a more sustainable manufacturing and logistics process.
Single-use systems are closed systems that ensure the most important aspect in ADC processing - Safety.
This is the case with single-use technologies, which are replacing traditional stainless-steel systems at an increasing rate. Single-use components can simplify systems for aliquoting and filling of ADCs.
Single-use components, such as sterile
all contribute to the design of closed systems for the handling of potentially toxic substances that are required for the production of ADCs and other therapeutic drugs. By eliminating the need for manual handling, any risks of contamination can basically be ruled out.
Thanks to their scalability, single-use technologies can cover the entire spectrum from small-scale lab sampling to full-scale bulk production. While lab samples are miniscule, bulk drug substance needs to be aliquoted in large bags, and protected for a safe and reliable transport.
As a fully automated and scalable aseptic filling and filtration system for bags or bottles, Single Use Support’s RoSS.FILL enables maximum flexibility for both the aseptic filling and draining process. With RoSS.FILL, it is possible to fill unlimited volumes per batch at a speed of up to 300 liters per hour. And because the entire process is fully disposable, it guarantees an absolutely sterile filling and aliquoting process.
The platform is available as a standard version that can be adjusted to meet varying needs - for small-volume 3D bags all the way to 1,000 L and more. Depending on the project criteria or requirements, for example speed, filling accuracy, scalability or homogeneity, with RoSS.FILL Single Use Support can fulfill all needs.
By employing single-use technology, CMOs and manufacturers can significantly advance ADC manufacturing while also increasing process efficiency, process flexibility and sustainability and reducing costs.
Some ways single-use technology can advance ADC manufacturing include:
In summary, single-use technology can significantly advance ADC manufacturing by improving efficiency, reducing costs, and increasing flexibility. As the demand for ADCs continues to grow, the adoption of single-use technology is likely to become more widespread.