Contract development and manufacturing organisation (CDMO) ten23 health has launched Line 0, a non-GMP pilot sterile fill & finish service at its Basel facilities.
Co-developed with pharma packaging expert Optima, the purpose-built sterile filling line can product RTU and bulk containers, including vials, syringes and cartridges in combination with a 1.1m2 lyophiliser.
With Line 0, customers can utilise ten23's scaled-down, time- and cost-efficient process development services, while accessing aseptically produced drug product batches that do not require GMP grade.
The pilot line avoids the extra costs and constraints of performing such activities in GMP manufacturing facilities or using non-representative equipment in labs.
“This technology will improve manufacturing efficiency and add value to our customers' projects, noted Hanns-Christian Mahler, CEO at ten23 health.
"We can now provide complete solutions from the development and preclinical scale to clinical and commercial manufacturing scale, with purpose-built scaling and transfer in mind,” he added.
Operated under the ISO9001 quality management system, Line 0 is designed to provide aseptically filled batches which may be required for specific purposes such as the implementation of novel processes or primary packaging, stability testing, analytical reference materials and preclinical study material.
The new offering is compatible with novel primary packaging as well as related process development and characterisation assessments for filling, stopper setting and lyophilisation processes.
It integrates different manufacturing scales at ten23, from the new Pilot “Line 0” (non-GMP) in BASE® (Basel) to the VIVA1 and VIVA2 GMP fill& finish lines (Visp), all of which Isolators in Class C environment in Annex 1 GMP compliance.
Line 1 is suitable for clinical and commercial applications, using ready-to-use (RTU) containers, while Line 2 is for large-scale commercial RTU production and Line 3 is for clinical and commercial bulk-vial liquid or lyophilisate manufacturing.
All sterile manufacturing lines are based on Optima equipment platforms, enabling easy scale-up and ensuring they are fit-for-purpose for the specific needs of each customer.