Drug product manufacturing from early development to commercial

Zofingen is the headquarters of the Siegfried Group and one of Siegfried’s two launch sites for newly developed processes. 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Siegfried Evionnaz is one of Siegfried’s two launch sites for newly developed processes. It specializes in custom synthesis of active ingredients and intermediates for the pharmaceutical industry. With an R&D Center housing advanced chemical and analytical facilities, state-of-the-art laboratories, and cutting-edge technologies, it offers chemical process R&D and analytical development services for Siegfried’s global Drug Substances network. 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

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.

Siegfried Hameln is one of Siegfried’s six Drug Products sites globally. It is a leading manufacturer of parenteral solutions, producing a wide range of aseptic and terminally sterilized products in ampoules and vials, 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Siegfried Minden is one of Siegfried’s five run and deliver sites for established processes. It 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.

Siegfried St.Vulbas is one of Siegfried’s five run and deliver sites for established processes. It 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.

Siegfried Barberà is one of Siegfried’s six Drug Products sites globally. It 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. It has a dedicated Development Center offering development and scale-up services for solid dosage forms and inhalation capules. 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. Its state-of-the-art production equipment integrates Industry 4.0 technologies, such as digitization, system integration, robotics, and automation, ensuring precise processes. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Siegfried El Masnou is one of Siegfried’s six Drug Products sites globally. It 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. It has a dedicated Development Center offering development and scale up services focused on sterile ophthalmic products. 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Siegfried Malta is one of six Siegfried’s Drug Products sites globally. It 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.

Siegfried Irvine is one of Siegfried’s six Drug Product sites globally. It 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Siegfried Pennsville is one of Siegfried’s five run and deliver sites for established processes. It 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.

The Siegfried Acceleration Hub in Grafton specializes in early-phase development and manufacturing. Established in 1998, the site offers phase-appropriate analytical and development services, regulatory expertise, and regulatory-compliant quality systems — all with the capability to manage highly potent and controlled substances. The Acceleration Hub provides end-to-end life cycle management with services from preclinical through commercial, including scale-up, tech transfer, validation and launch, with seamless transfer into Siegfried’s global network. The site has a broad portfolio of technologies and capabilities, including phase-appropriate preclinical process development, advanced filtration technologies, CMC sections of DMFs, alternate synthesis, route scouting and more. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.

Siegfried Wilmington, is one of Siegfried’s five run and deliver sites for established processes. It is a large-scale commercial manufacturing facility for innovative products and controlled substances, supporting a wide range of therapeutic applications. Established in 1979, the multi-purpose site today offers 150 cubic meters of reactor capacity with a wide range of technologies, operating to the highest regulatory and quality standards.

Siegfried Nantong is one of Siegfried’s five run and deliver sites for established processes. It 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. All activities are conducted in strict compliance with quality standards (GMPs) and with safety, health protection and environmental standards.