Drug Product Manufacturing
Fill-finish, built flexibly.
Manufacturing sterile drug products is more than filling containers; it’s about designing, characterizing and validating every step to deliver safe, high-quality medicines for Patients. At ten23 health, we use state-of-the-art isolator technology to perform aseptic drug product manufacturing for clinical and commercial supply.
From clinical manufacturing services through cGMP manufacturing, we offer your drug product the best approach in sterile fill finish.
A seamless approach from start to sterile finish
- Comprehensive processes: Sterile drug product manufacturing consists of multiple operations: from thawing and pooling drug substances, compounding and sterile filtration, to filling RTU containers such as vials and syringes.
- Compelling capabilities: Including closure, capping and 100% visual inspection with AQL testing to meet GMP and pharmacopeial standards. Outlook 2026: enhanced services with lyophilization (freeze-drying)
- Sterility ensured: Biologics require aseptic processing to maintain stability and product quality, achieved through meticulous sterile filtration and contamination control.
Manufacturing Process Transfer, Characterization and Validation
Our experts design robust sterile fill-finish manufacturing processes by thoroughly understanding active ingredient liabilities, formulation behavior and process performance. We evaluate unit operations, establish process ranges linked to critical quality attributes (CQA) of the drug product, and support all aspects of transfer, scale-up and validation, from filter selection and lyophilization to smooth tech transfer and commercial process validation.
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Our experts at ten23 health support clients in designing an appropriate and robust manufacturing process for sterile fill-finish manufacturing. This includes material and supplier selection, as well as in-depth assessments and experiments related to individual process unit operations, and assessing product CQAs as a function of the chosen parameters. As an example, we can develop and improve lyophilization processes, as well as support filter selection, scale-up, and closure/capping.
The same diligence will be employed to transfer your process smoothly into our facility, as well as for successful validation of your process for commercial supply.
Stability Samples, Reference Standards & Pre-clinical Supplies manufacturing
At our ten23 health facility in Basel - BASE®, we manufacture representative stability samples for regulatory filings (IND, IMPD, BLA, MAA) supporting setting product shelf-life , as well as serve engineering runs for later GMP fills. With our pilot line (find out more on our lines here), we can fill analytical reference standards and provide fully representative pre-clinical supplies for GLP toxicology studies. We offer flexible filling into vials, syringes, and cartridges at varying scales, delivering liquid or lyophilized dosage forms to support your development and quality control needs.
Clinical and Commercial Fill & Finish
Our GMP-approved, Swissmedic- and FDA-inspected sterile manufacturing site in Visp (VIVA1®), equipped with an isolator line and flexible fill line for a variety of containers, produces clinical and commercial batches of vials, syringes, cartridges, and special devices with precision and minimal losses, handling batch sizes from 500 to 20,000 units. Our expanded capacity with two additional filling lines at VIVA2® helps us meet growing sterile manufacturing demands.
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Our capabilities for sterile manufacturing on line 1 / VIVA1:
Clinical (phase 1 – 3) and Commercial (launch and initial supply) GMP manufacturing on the same line – saving time and material by avoiding costly transfers
Compounding volume 1 to 200 Liters, in glass bottles or plastic containers
Able to process a variety of Ready-to-use (RTU) containers, from vials (e.g., 2R to 30R) to syringes (e.g., 1 and 2.25 mL syringes), cartridges, and special containers for specific drug/device combination products, such as for the West SmartDose Device. All on the same filling line
Vials: courtesy of Stevanato Group
Syringe: courtesy of Terumo Europe
Cartridge and Smartdose: courtesy of West PharmaExperience with both glass and Polymer containers
Isolator based technology
Single or double sterile filtration with the option to perform PUPSIT (pre-use post sterilization integrity testing)
100% IPC testing for product weight (fill volume control)
Peristaltic or piston pump filling options
Super high-precision filling of small fill volumes such as 100 µL
No need for product-specific Cleaning Validation (dedicated and/or single-use materials)
Closed processing possible
Dedicated compounding room in class “C” environment
Open handling under laminar airflow (LAF) class “A”
Offline IPC testing, such as pH, osmolality, concentration, conductivity and density
100% visual inspection and AQL (acceptable quality level) testing
Our Expansion for sterile manufacturing (Line 2 and 3 / VIVA2)
read press release about the expansionLine 2
- Clinical and Commercial larger-scale GMP manufacture
- Same technology as Line 1, hence a direct and easy transfer to Line 2
- 8-headed filler
- Able to process a variety of Ready-to-use (RTU) containers, from vials (e.g., 2R to 30R) to syringes (e.g., 1 and 2.25 mL syringe), cartridges and special containers for specific drug/device combination products, such as for the West SmartDose Device.
- Experience with both glass and Polymer containers
- Isolator based technology
- Single or double sterile filtration with the option to perform PUPSIT (pre-use post sterilization integrity testing)
- 100% IPC testing for product weight (fill volume control)
- Peristaltic or piston pump filling options
Available for sterile filling from the end of 2024 onwards
Line 3
- Clinical (phase 1-3) and Commercial larger-scale GMP manufacture
- Bulk vial processing and Lyophilisation
- 2x 12.5 m2 Lyophilizers
- Able to process a variety of containers, from vials (e.g., 2R to 30R)
- Isolator based technology
- Single or double sterile filtration with the option to perform PUPSIT (pre-use post sterilization integrity testing)
- 100% IPC testing for product weight (fill volume control)
- Peristaltic or piston pump filling options
- Available for sterile filling from the end of 2025 onwards
Our strengths:- Clinical fills and commercial supplies out of one facility, without the need for lengthy and risky transfers
- Fill & finish services for complex drug products, such as intravitreal preparations or subcutaneously formulations
- Focus on maximum yield (minimum product losses)
- Highest filling accuracy
- 100% IPC for filled product weight
- Zero risk of cross-contamination
- Small volume filling (≤100µL), e.g., for intravitreal injection preparations
- Bubble-free filling
- Filling of highly viscous formulations
- Accurate stopper setting (+/- 0.5mm)
- Able to process Glass and COP/COC primary packaging
- Open to implement new formats and new generations of primary packaging
Sterile solutions, built differently.
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We're ready for what comes next.