Smaller batch, personalized medicines show great promise. They're just not very scalable. Cytiva’s flexible approach to aseptic filling in biomanufacturing aims to change that.
The biotech industry is buzzing with a promising pipeline of innovative drugs that are more targeted, personalized, and effective than treatment options of the past. As demand for new therapies is expected to ramp up and drug developers increase capacity, finding reliable ways to maintain sterility at all stages of the manufacturing workflow and through to patient administration will be crucial. While biopharma does the exciting work to perfect the biology, a quieter sector of the life sciences community is developing the cost-effective, efficient, and scalable aseptic filling solutions needed to safely and efficiently move groundbreaking treatments from discovery to delivery.
Closed, automated aseptic filling technology reduces contamination risk and drives consistency
Taking a large batch of liquid medicine and dispensing it into containers holding smaller volumes is a necessary step to broadly distribute drug doses. However, traditional methods of filling vials, syringes, or cartridges, can potentially introduce contamination and variability. Since contaminated drug products can cause illness or even death, drug manufacturers rely heavily on environmental monitoring and product testing to catch these issues before they reach the clinic.
Humans, while historically playing a central role in aseptic filling, also serve as a primary source of the microbes or measurement errors that can make a batch or dose of drug unfit for patient administration. To keep up with anticipated future production demands, drug manufacturers will need to move away from manual aseptic processing and toward closed, automated solutions. Completing the aseptic filling step in a closed, sterile system reduces contamination risk at the source, and automation allows for the strict process control required for commercial manufacturing.
Advances in aseptic filling technology will help bring innovative treatments to market
Successful integration of aseptic filling solutions into manufacturing workflows is essential to getting high quality therapies to market. The latest aseptic filling technologies are being designed to safely and efficiently deliver more complex, personalized medicines to patients, avoiding the bottleneck that can occur at this stage of the pipeline.
Cytiva’s aseptic filling workcells, for example, support sterile filling by using robotics, gloveless isolators, and machine vision to automate the process in a scalable way and without the need for direct human contact. Their modular, flexible design allows manufacturers to produce smaller therapy batches with reduced risk of contamination, greater efficiency, and minimal downtime between different production runs.
Cytiva is preparing to meet the industry’s increased need for reliable aseptic filling solutions
Since acquiring its aseptic filling business in 2021, Cytiva has focused on developing solutions that provide sterility assurance while driving efficiency. Our newly opened Center of Excellence in Vancouver now houses training facilities and production systems that deliver advanced aseptic filling solutions to biomanufacturers around the world. Anticipating the biopharma industry’s continued need for aseptic filling technologies, Cytiva is also maintaining a production floor that can accommodate future growth and is expanding capacity for ongoing research and development.