Clinical solutions

We translate preclinical results into GMP-compliant manufacturing for human use, typically starting with Phase 1 clinical trials. Our services cover all stages of clinical development and are designed to support a seamless transition toward commercial production.

We provide guidance tailored to the specific requirements of each lifecycle phase, helping to identify the most suitable manufacturing approach.

Development / clinical line for SMALL SCALE 

Our semi-automatic line, operating within an isolator, enables the production of clinical batches of up to 1,000 units. We use Ready-to-Use (RTU) pre-filled syringes and/or RTU vials, ensuring flexibility based on your needs. The line is equipped with a small freeze dryer, allowing us to support both liquid and lyophilized (freeze-dried) formulations for your initial clinical supply. 

Commercial lines for SCALEABILITY 

Production directly on commercial lines from Phase 1 assures lower costs during the whole lifecycle, as no tech transfer, scale-up is needed and Phase 3 (or commercial supplies) are assured by the same production processes.  

We provide a wide range of vial formats, from 2R to 200H, accommodating batch sizes from 1 liter to 1,500 liters, covering all clinical phases. For pre-filled syringe production, we utilize a flexible single-use system platform to support clinical supplies efficiently and reliably. 

• Platform-based process strategies  
  Proven platform technologies enable fast production readiness and efficient scale-up.
• Dedicated project management 
  A designated project manager acts as your central contact, ensuring clear coordination throughout the project.
• Specialist project support 
  Internal experts from relevant functions provide hands-on support to ensure smooth project execution.
• Single-use systems
  Single-use technologies for compounding, filtration, and filling help reduce product loss, lower cross-contamination risk, and simplify cleaning requirements.
• Sample handling and logistics 
  Coordinated sample management and logistics processes ensure traceability and product quality at every step.
• Scientific and development support 
  Our in-house scientific teams are available to resolve technical challenges and support informed decision-making.