Fill-Finish For Prefilled Syringes, Cartridges And Vials

Siegfried is a leading sterile injectable CDMO providing end-to-end aseptic and sterile fill-finish solutions for pharmaceutical and biotechnology companies worldwide. From development and technology transfer to commercial manufacturing, we support the complete lifecycle of injectable drug products.

Our state-of-the-art facilities and experienced teams deliver sterile fill-finish services for prefilled syringes, cartridges and vials, ensuring the highest standards of quality, compliance and supply reliability.

Your trusted partner for sterile and aseptic contract development and manufacturing

• Expertise: Deep expertise in sterile and aseptic process development, analytical development and technology transfer for injectable drug products.
• Reliability: Reliable sterile manufacturing and commercial supply, delivering speed to market without compromising quality or compliance.
• Agility: Flexible aseptic fill-finish capabilities for complex injectable products, supporting clinical development through commercial launch.

Our wide range of services for sterile and aseptic fill-finish

Development services for sterile injectable drug products

• Our flexible development platform supports sterile and aseptic injectable drug products in vials, cartridges and prefilled syringes for both small molecules and biologics. From formulation development to commercial readiness, our experts help optimize product performance, manufacturability and regulatory compliance. Evaluating primary packaging systems, container closure integrity and compatibility for prefilled syringes, cartridges and vials
• Selecting and optimizing filtration strategies for sterile manufacturing processes
• Improving formulation stability and product performance for injectable drug products
• Identifying optimal mixing, filling and dosing technologies
• Assessing product-contact materials, packaging interactions and extractables and leachables
• Developing terminal sterilization cycles and evaluating sterilization impact on product quality
• Producing laboratory-scale and non-GMP development batches to support early-stage programs

Analytical development

Our experienced analytical development team supports sterile and aseptic injectable drug product programs with cGMP-compliant analytical testing throughout the product lifecycle. Working closely with our drug substance experts and leveraging the capabilities of Siegfried’s global network, we provide integrated analytical support from early-stage development through commercial manufacturing.

Our analytical services include method development, method validation and qualification, formulation support, stability studies, GMP batch release testing and ongoing quality control. We also offer specialized bioanalytical capabilities through our development center in Hameln, supporting both small molecules and biologics.

Scale-up and clinical manufacturing

We seamlessly scale sterile and aseptic injectable drug products from development to clinical and commercial manufacturing. Whether starting with a new formulation, a transferred process or a product developed by Siegfried’s drug product development teams, we ensure a smooth and efficient transition to the next stage of manufacturing.

Siegfried provides cGMP manufacturing of sterile injectable products from pilot-scale batches through commercial production, tailored to the requirements of each development phase.

Our facilities in Irvine and Hameln support global clinical supply with cGMP-compliant manufacturing of clinical trial materials for small molecules and biologics. Leveraging both fixed and single-use technologies, we manufacture clinical batches from 1-liter scale and support customers throughout the clinical development journey.

Technology and analytical method transfer

Siegfried designs manufacturing processes with commercial readiness in mind, enabling efficient scale-up, technology transfer and successful progression to commercial manufacturing.

Our flexible and scalable solutions support a broad range of sterile and aseptic injectable drug products, including both NDA and ANDA programs. With extensive expertise in process design, manufacturing technologies and regulatory requirements, we ensure seamless transfer and scale-up across our global manufacturing network.

Siegfried supports complete technology transfer of your product to our U.S. and European manufacturing sites, providing continuity from development through commercial supply. Services include:

• Transfer and qualification of analytical methods, including cleaning validation
• Process transfer, scale-up and manufacturing readiness assessments
• Process qualification and validation
• Manufacture and release of registration and validation batches
• Packaging according to customer specifications
• Stability studies in accordance with ICH guidelines
• Regulatory and registration support
• Product lifecycle management and continuous process improvement

Commercial fill-finish and packaging

Siegfried provides commercial sterile and aseptic fill-finish services for injectable drug products, delivering market-ready products in compliance with global cGMP requirements and customer specifications. Our integrated manufacturing and packaging capabilities support reliable commercial supply across international markets.

Primary packaging

• Vials (2–250 ml), including standard glass, pre-siliconized and RTU configurations
• Ampoules (1–30 ml)
• Cartridges (1-10 ml)
• Prefilled syringes (1-50 ml)
• Multiple filling technologies, including single-use systems, peristatic pumps and piston pumps

Visual inspection and secondary packaging

• Manual, semi-automated and fully automated visual inspection
• Crack detection and defect identification
• Labeling of vials, ampoules, cartridges and prefilled syringes
• Packaging in thermoformed blisters and tamper-evident serialized cartons

Tertiary packaging and supply chain support

• Bundling and aggregation
• Shipper and pallet aggregation
• Market-specific packaging and serialization requirements
• Global commercial supply and distribution readiness

Technical capabilities

Siegfried’s sterile and aseptic manufacturing capabilities support a broad range of injectable drug products, including small molecules, biologics and vaccines. Our integrated infrastructure, advanced manufacturing technologies and experienced technical teams enable efficient development, fill-finish and commercial supply for global pharmaceutical markets.

Our technical capabilities include:

• Sterile and aseptic fill-finish of small molecules, biologics and vaccines
• Cold-chain storage, management and distribution
• In-house microbiological, chemical and analytical testing laboratories
• Raw material, in-process and finished product testing
• Stability studies and quality control services
• Final packaging in market-ready configurations, including serialization and aggregation for global supply

Our manufacturing facilities are equipped with industry-leading technologies from trusted partners including Bosch, Steriline, Innoscan, Groninger, Bausch + Ströbel, Seidenader and Uhlmann.

Facilities

Storage facilities for raw materials and finished products are available at temperatures down to –78°C. All facilities are routinely inspected by national and international regulatory authorities and operate in accordance with global cGMP requirements. Siegfried also holds national licenses for the handling of controlled substances.