Steriles
Your most trusted partner for sterile and aseptic fill & finish
Our wide range of services for steriles
Pharmaceutical development
Our flexible platform offers the development of standard and complex injectable formulations in the area of small molecules as well as biologics. Siegfried’s development experts support you with:
- Evaluating primary packaging materials regarding compatibility and container closure integrity
- Selecting the suitable filtration system
- Optimizing the formulation to improve drug product stability
- Identifying the best mixing and dosing system (e.g. peristaltic or rotary piston pumps)
- Studying production material and packaging interactions with your formulation and supporting leachable and extractable studies
- Developing terminal sterilization cycle and evaluating terminal sterilization effects
- Non-GMP manufacturing of laboratory scale batches
Analytical development
Our well-experienced drug product analytical development team supports development projects with cGMP-compliant analyses, working with their counterparts covering drug substances to support your product at every phase in the development process. With access to the analytical resources of our global network, analytical services range from development activities, method quantification and formulation support, to commercial GMP batch release and stability testing. We are also able to support several bio-analytical methods out of our development center in Hameln.
Scale-up and clinical trial material production
We take your process to the next manufacturing level quickly and smoothly regardless of your starting point, whether it is a new, modified or existing formulation developed by our drug product development team. Siegfried offers cGMP-manufacturing of batches ranging from pilot to commercial scale depending on your specific needs.
Siegfried offers drug product clinical trial manufacturing under cGMP conditions at our Irvine and Hameln facilities, serving all the countries where your clinical study is carried out. Utilizing fixed or disposable technologies, Siegfried manufactures clinical trial material from 1L scale.
Process and analytical method transfer
Siegfried plans and designs processes from an early development phase, ensuring a successful scale-up and transfer to commercial production.
Our adaptable and scalable solutions cater to a wide range of formulation and project needs, encompassing both ANDA and NDA products. We offer specialized knowledge in equipment and process design to support your project seamlessly throughout every stage of manufacturing. Siegfried supports complete process transfer of your product to our US or EU locations. Services include:
- Transfer of analytical methods (including cleaning validation)
- Transfer and/or scale-up of the production process
- Process qualification and validation
- Manufacture and release of registration batches
- Packaging according to customer specifications
- Stability testing according to ICH
- Support in registration activities
- Life cycle management
Commercial manufacturing and packaging
Siegfried supplies sterile injectables packed and ready to market worldwide in accordance with all cGMP, customer and market-specific requirements:
- Primary packaging
- Vials (2- 250ml) ), standard glass; pre-siliconized; RTU configuration depending on format
- Ampoules (1- 30ml)
- Cartridges
- Pre-filled syringes
- Different filling technologies (i.e. single use, peristaltic or piston pumps)
- Visual inspection and secondary packaging
- Manual, semi and fully automated visual inspection including crack-detection
- Labeling of vials and ampoules
- Packaging in thermoformed blisters and tamper evident serialized folding boxes
- Tertiary packaging
- Bundling and aggregation
- Shipper and pallet aggregation
Technical capabilities
Our technical capabilities cover:
- Fill & finish of small molecules, biologics, and vaccines
- Cold-chain management and distribution
- In-house technical expertise and microbiological and chemical laboratories for both incoming raw materials, in-process and finished product testing capability, stability testing services
- Final packaging in ready-to-market configurations including serialization and aggregation for global supply
Siegfried is equipped with well-known and renowned brands like Bosch, Steriline, Innoscan, Groninger, Bausch + Ströbel, Seidenader and Uhlmann.
Facilities
Storage facilities for raw materials and finished products at temperatures as low as –78°C are available. All facilities are routinely inspected by national and international authorities. National approvals for handling of controlled substances are available.
Our competency centers
Europe
Zofingen
Zofingen is the headquarters of the Siegfried Group. The production site specializes in the development and commercial manufacturing of active pharmaceutical ingredients (APIs) and intermediates, including high potency APIs. Founded in 1873, the site has a broad portfolio of technological capabilities including hydrogenation, organometallic and hydride chemistry, halogenation, methylation, milling and micronization and more. Its production and development processes adhere to the highest quality standards, including Good Manufacturing Practices (GMP), and dedication to safety, health protection and environmental responsibility.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Highly active and controlled substances
- Custom synthesis
4800 Zofingen Switzerland
Evionnaz
Siegfried Evionnaz specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 1957, the site has a broad portfolio of technologies including micronization, azide chemistry, hydrogenation, halogenation, organometallics, cryogenics, and more. Focused on niche technologies, the facility possesses development capacity from 1 gram to industrial-scale production, with all activities in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Custom synthesis
1902 Evionnaz
Switzerland
Zurich
DINAMIQS, a Siegfried company, is a science-driven Contract Development and Manufacturing Organization offering end-to-end viral vector manufacturing solutions to accelerate gene therapy projects from DNA design to commercial scale. DINAMIQS offers a comprehensive and customized range of manufacturing services, process development, quality control and analytics solutions for genetic medicine companies.
Competencies
- Viral vectors
Hameln
Siegfried Hameln is a leading manufacturer of parenteral solutions, producing a wide range of aseptic and terminally sterilized products in ampoules and vials for pharmaceutical companies, with a dedicated development center for sterile injectables. Its specialization lies in the production of complex formulations, including anesthetics, flammable substances, oxygen-sensitive liquids, and cold chain products, all while ensuring strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards. The site has a broad portfolio of technological capabilities including cold-chain handling, automated visual inspection and packing and more.
Competencies
- Sterile and aseptic filling of ampoules and vials
- Biologics and small molecules
31789 Hameln
Germany
Minden
Siegfried Minden specializes in synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 1935 and focused on efficient operations and special technologies, the facility possesses production capacity from approximately 25 kilograms to multi-100-ton-scale production. The site has a broad portfolio of technological capabilities such as hydrogenation, organometallic and hydride chemistry, milling and micronization, halogenation and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Highly active and controlled substances
- Custom synthesis
Karlstrasse 15
32423 Minden
Germany
St.Vulbas
Siegfried St. Vulbas specializes in synthesis of active ingredients, intermediates and custom synthesis for the pharmaceutical industry. Established in 1993, the site has a broad portfolio of technological capabilities such as organometallic and hydride chemistry, phosgenation, hydrogenation, halogenation and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Custom synthesis
530 Allée de la Luye
01150 Saint Vulbas
France
Hal Far
Siegfried Malta specializes in the manufacturing of oral solid dosage forms (OSD), encompassing tablet and capsule formulations with diverse release profiles (IR, SR, DR), formulations and technologies. Established in 2007 as one of the first OSD sites within the Siegfried network, technologies range from dry blends, aqueous and organic – wet/dry granulation (bottom with Wurster technology and top spray), tableting, encapsulation, coating and blister packaging. The facility has the ability to produce manufacturing batch sizes on a mid – large scale, with a focus on tech transfer and scale up activities. All operations comply strictly with quality standards (GxPs), safety, health protection and environmental standards.
Competencies
- Bulk manufacturing and packaging of solid dosage forms for oral applications
Hal Far BBG 3000
Malta
Barberà del Vallès
Siegfried Barberà specializes in manufacturing and packaging solid oral dosage forms (OSD), including high-potency and inhalation capsules for treating respiratory diseases. Established in 1994, the site supplies products worldwide including Japan and the USA. The site has a wide range of equipment to produce solid formulations on a small and large scale, with blister, bottle and wallet/Shellpak packaging forms. Our state-of-the-art production equipment integrates Industry 4.0 technologies, such as digitization, system integration, robotics, and automation, ensuring precise processes that meet quality, safety, and environmental standards. A new Development Center was established in 2021 with facilities in Barberà and El Masnou. The center in Barberà offers development and scale-up services for solid dosage forms and inhalation capules.
Competencies
- Bulk manufacturing and packaging of solid dosage forms for oral applications including high potency
- Inhalation capsules for medical devices to treat respiratory diseases
08210 Barberà del Vallès (Barcelona)
Spain
El Masnou
Siegfried El Masnou has a long track record of expertise in manufacturing aseptic products, with the site established in 1925. It is the largest factory in Spain specialized in ophthalmic products, both eye drops and sterile eye care ointments, as well as products for nasal and otic use. The site’s technological capabilities include ball milling molturation, pre-use post sterilization integrity testing, and multi-dose round, oval and preservative-free bottles. Processes are fully automated and use cutting-edge technology, embracing Industry 4.0 technologies like system integration, robotics, and extensive automation. Facilities, equipment, and environmental conditions adhere to the strictest manufacturing standards. A new Development Center was established in 2021 with facilities in El Masnou and Barberà. The center in El Masnou offers development and scale up services focused on sterile ophthalmic products.
Competencies
- Bulk manufacturing and packaging of sterile ophthalmic products, including eye drops, eye ointments, otic/nasal sprays
08320 El Masnou (Barcelona)
Spain
USA
Pennsville
Pennsville is Siegfried’s drug substance manufacturing site for the US market and provides spray drying operations globally. Established in 1928, its main activities are pilot and commercial manufacturing of drug substances (APIs) and intermediates, in a fully cGMP and SHE compliant manner. The site has a broad portfolio of technological capabilities including spray drying, organometallic and hydride chemistry, hydrogenation, milling and micronization and more.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Highly active and controlled substances
- Custom synthesis
Pennsville, NJ 08070
USA
Irvine
Siegfried Irvine is a sterile drug product manufacturing site, specializing in innovative and difficult to manufacture pharmaceuticals, ophthalmics, and drug delivery devices. It provides cGMP sterile drug product fill and finish of biologics, suspensions, emulsions, ointments, and gels in a fully compliant manner. Established in 2002, the site’s technological capabilities include state-of-the-art filling lines for vials, droptainers and prefilled syringes; bulk filling capabilities; and low oxygen, light sensitivity, low humidity and non-aqueous product handling.
Competencies
- Sterile and aseptic filling of large and small molecules
Grafton
The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing services, including services for projects with highly potent APIs.
Competencies
- Early-phase development and manufacturing
Asia
Nantong
Siegfried Nantong specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. Established in 2013, the chemical plant’s technological capabilities include organometallic chemistry, hydrogenation, alkylation, amination, chlorination and milling. The facilities offer services from process development, scale-up to industrial production, in full compliance with GMPs and with safety, health protection and environmental standards.
Competencies
- Active pharmaceutical ingredients (API) and intermediates
- Custom synthesis
Nantong City, Jiangsu Province
P.R.C. (post code: 226017)