Drug device combination manufacturing and development

We’re a pioneering solutions provider for drug device combination products, handling multiple needle-based injection system formats, such as fixed and variable dose pen devices with cartridges, autoinjectors with pre-filled syringes and safety syringes.

We deliver end-to-end services from device conceptualization and selection to modular automated device assembly and packaging for clinical and commercial supplies, enabling you to execute your projects with enduring success. And we can accelerate your device development programs with unmatched technical expertise and robust partnerships with industry-leading device manufacturers, ensuring smooth technology transfers. Every. Single. Time.

Flexible manufacturing capabilities

Our high-end automated filling lines with integrated isolators are designed with one goal in mind: to meet your clinical and commercial drug supply needs. We’ve made flexibility our competitive edge, as we have handled over 20 assembly machines and qualified customized equipment specific to customer selected device and assembly manufacturing. We convert drug substances into stable formulations and handle fill-finish in one facility. Our automated packaging lines include state-of-the-art labelers, syringe assembly systems, blistering and cartoning. Plus, our large-scale warehouses feature cold chain inventory management, accommodating temperature ranges from -80°C to 25°C.

Formats  Equipment  Working Range  Annual capacity 
Cartridge   Bausch and Strobel filling line integrated
with Steriline isolator 		 1.5 – 3 ml  

Diameter: 7 – 14 mm
Height: 40 – 90 mm 

 40 million 
Pre-filled syringes  Bausch and Strobel filling line integrated
with Steriline isolator 		 0.5 – 10 ml  28 million 
Pen and autoinjectors  Mikron / Tofflon  40 – 200 PPM  36 million 

Drug device combination development

We deliver value for our customers at every stage:

Device selection and customization

  • We characterize the Reference Listed Drug (RLD) or Reference Medicinal Product (RMP) and evaluate multiple platforms based on IP, design, cost and timelines. Plus, we nail down assembly processes and fix any technical hurdles – fast.

End-to-end development

  • From finalizing device specifications to qualifying assembly lines, we’ve got it covered. And when it comes to technology transfer, we’ve successfully completed over 140. We also handle validation and support studies with precision.

Device assembly and customization

  • We push for over 95% Overall Equipment Effectiveness (OEE) by optimizing device design with Critical to Function (CtF) and Critical to Process (CtP). By collaborating with suppliers from day one to implement Design Failure Mode Effect Analysis (DFFMEA), Design Qualification (DQ) and rigorous testing, we ensure flawless qualification.

Quality Management Systems  

Quality is central to our culture. That’s why we have designed robust quality management systems that our Quality Control and Analytical Development teams live by. They’re built to make our teams proactive and responsive in ensuring all-time compliance with global standards from developing and deploying robust quality systems, continuous governance through effective metrics and risk mitigation strategies.  

Regulatory

We don’t just meet regulatory standards – we uphold them. With two decades of compliance excellence and 138 successful audits under our belt, we’re the CDMO that regulators trust. Our track record speaks for itself – did you know that 100% of our regulatory inspections passed without any critical observations? Our flagship site, providing drug device combination expertise, has FDA approval from the CDER and CDRH1. Plus, our sites are equipped for long-term and accelerated drug product stability studies according to ICH guidelines, pen device assembly and release of the drug products as per ISO standards.

Our highly experienced teams can anticipate regulatory shifts and provide comprehensive regulatory support at every stage of drug product development. For instance, our early adoption of isolator filling lines ensures sterility assurance and compliance. What’s more, we have deep expertise in DHF requirements and execute support studies that ensure robust regulatory submissions to the US FDA and EMA.

State of the art facilities

We set the benchmark for CDMO excellence. With five state-of-the-art cGMP facilities accredited by top regulatory bodies, we ensure quality and compliance from concept to commercialisation.

Our flagship facility boasts:

  • 20+ standalone assembly equipment setups, all qualified for customer use
  • Customizable assembly lines designed for autoinjectors and pen devices, achieving speeds of 10 or 40 ppm
  • Expansion capabilities for cartridge and device assembly for up to 100+ million units
  • A high-volume, fully automated assembly line in the works, pushing for 160 ppm for both pen and autoinjector production

Ready to bring drug device combination products to life?

Contact us