ten23 health, a contract development, testing, and manufacturing organization headquartered in Basel, Switzerland, announced on June 30, 2025 that it has joined the “Alliance for RTU,” a partnership launched in September 2024 by primary packaging manufacturers Gerresheimer, SCHOTT Pharma, and Stevanato Group, with the intent of advancing technical knowledge and expertise about the sterile manufacturing of ready-to-use (RTU) containers (1).
Reaction to changing market demands
Key Takeaways
- ten23 health has joined the Alliance for RTU to support advancements in sterile, ready-to-use container technologies for aseptic drug manufacturing.
- The collaboration emphasizes standardization and regulatory-compliant development of RTU platforms to improve efficiency in sterile fill/finish processes.
- Shifts in sterile manufacturing include isolator tech adoption and packaging tailored to personalized medicine, at-home use, and chronic disease treatments.
In a press release, ten23 health said the Alliance for RTU was formed in response to an increased need in the market for aseptic filling technologies and processes (1). The platform provides a means of technical exchange on high-quality, ready-to-fill primary packaging between pharmaceutical companies, contract manufacturers, and contract development and manufacturing organizations. ten23 health said its role would be to contribute its experience in development, sterile fill/finish, and testing of sterile drug products using RTU containers.
That experience, the company said, is based on a wide range of customer projects aimed at furthering the development and standardization of RTU container platforms, to improve both efficiency and quality while remaining compliant with regulatory standards (1).
How sterile manufacturing is adapting
Sterile manufacturing, including fill/finish and packaging services, was top of mind for Hanns-Christian Mahler, PhD, founder and board member of ten23 health, when he spoke to Pharmaceutical Technology® during CPHI Milan 2024. At that time, Mahler said revisions to regulatory guidance were having an impact on fill/finish facilities.
“From my vantage point, I truly believe in isolator technology,” Mahler said in the interview. “So, that’s where I think an isolator in cleanroom, Class C, is probably where you would want to go if you’re building new facilities. And I think a lot of struggles are ongoing with a lot of folks where, they're trying to actually make upgrades from a filling environment, and that obviously comes with a cost, with a shutdown, and with a potential risk ... [Sustainability] has been a key question … and how we want to operate from a footprint perspective.”
Click here to view the full video interview with Mahler.
Specificity of packaging trends
Prior to Pharmapack Europe in January 2025, Gerresheimer Global Vice-President Sales Pharma & Biopharma Solutions Stefan Verheyden talked to Pharmaceutical Technology® about various packaging trends, such as those that support at-home therapy and personalized medicine (3).
“[Gerresheimer is] becoming an organization that focuses on solutions in specific domains,” Verheyden said in the interview (3). “We want to make sure … we understand what the market needs, and that we anticipate those needs. And therefore, we think it is very important that we understand very well what happens in specific … disease areas, [for example], chronic disease, … repetitive treatments, oncology, all the diseases where we think a more customized product offering could be of an added value.”
Click here to view the full video interview with Verheyden.
ten23 health, which is financed through a long-term commitment from the international investment company 3i Group, is named after the Avogadro constant (6.022 × 1023), which represents the number of molecules in a sample of one mol (1).
References
1. ten23 health. ten23 health Joins the “Alliance for RTU”—An Association to Advance Technical Exchange for Ready-to-Use (RTU) Containers in Sterile Manufacturing. Press Release. June 30, 2025.
2. Thomas, F. CPHI Milan 2024: Fill/Finish and Sustainability. PharmTech.com, Oct. 9, 2024.
3. Haigney, S. Pharmapack Europe 2025: Packaging Trends. PharmTech.com, Jan. 22, 2025.