New non-GMP Line 0 offering is designed to give customers early access to clinically representative liquid and lyophilized batches—without the GMP price tag.

Ten23 health, the human-centric and sustainable contract development, testing and manufacturing organization (CDTMO), has launched a robot-assisted pilot sterile fill and finish line—named Line 0—from its BASE site in Basel.

According to the company, Line 0 enables pharmaceutical customers to accelerate drug development and reduce costs by producing non-GMP but clinically representative batches. It says the small-scale, aseptic line offers a practical alternative to costly GMP manufacturing during early-stage work such as primary packaging implementation, freeze-drying cycle development, and stopper setting evaluations.

The custom-designed system is a co-development with Optima and includes a fully downscaled filling line for ready-to-use (RTU) or bulk containers—vials, syringes, and cartridges—along with a 1.1 m² freeze dryer. The company says the setup replicates real-world processes, making it suitable for tasks like stability studies and analytical reference sample production, without the constraints of GMP manufacturing.

“We will add significant speed and value to our customers’ projects with this innovative technology and the additional services that seamlessly integrate with our sterile GMP manufacturing offerings,” said prof Dr Hanns-Christian Mahler, chief enablement officer at ten23 health.

“We can now provide complete solutions from development and preclinical scale through to clinical and commercial manufacturing, with purpose-built scaling and transfer in mind.”

ten23 health says Line 0 is operated under its ISO9001-certified quality management system and is compatible with novel primary packaging. It also believes the design supports effective process characterization for filling, stoppering, and lyophilization.

The new offering is designed to link seamlessly with the company’s GMP lines in Visp—VIVA1, VIVA2, and VIVA3—all based on Optima platforms. ten23 says this compatibility will enable straightforward scale-up from pilot to full-scale clinical or commercial production.

“With the addition of Line 0, we can support our customers earlier in development with batches produced using equipment that mirrors our GMP lines. This helps ensure reliable scale-up and supply across the product lifecycle,” said Dr Susanne Jörg, chief customer delivery officer at ten23 health.