Einleitungstext
Drug Products Siegfried offers a broad base of know-how in complex oral and sterile formulations of drug products available for custom development and manufacturing (CDMO), and licensing.

Drug Products Siegfried offers a broad base of know-how in complex oral and sterile formulations of drug products available for custom development and manufacturing (CDMO), and licensing.
The value we bring that you can expect more from includes:
Drug product development and manufacturing is provided at our Zofingen (Switzerland), Hal Far (Malta), Irvine (USA) and Hameln (Germany) locations.
With Siegfried as your preferred drug product partner, you benefit from our wide range of expertise in customer development and manufacturing, co-product development and manufacturing, as well a portfolio of finished dosage form products. Whatever your specific drug product requirements are, Siegfried offers more to meet your expectations.
Oral Solids
Siegfried is your expert in complex oral drug delivery systems with the most advanced development, manufacturing and packaging capabilities in the CDMO industry installed in state of the art facilities located in Zofingen (Switzerland) and Hal Far (Malta).
Both facilities are routinely inspected by international authorities that certify the high quality of our operations.
Steriles
In the critical field of sterile manufacturing where quality is at the highest standard in our industry, Siegfried is your expert in simple and complex formulations at our state-of-the-art facilities located in Hameln (Germany) and Irvine (USA). Both facilities are approved by the many regulatory authorities, including EMA and FDA.
Siegfried offers a broad base knowledge and experience in difficult to manufacture pharmaceutical formulations and combination drug delivery devices. The value we bring and our customers can expect more from includes:
Whatever your manufacturing requirements are, Siegfried will provide more to meet your expectations.
Biologics
Based on specific requirements for manufacture of biologics finished dosage forms, Siegfried has new capabilities at its sterile sites in Irvine, California and Hameln, Germany.
Recognizing that assurance of highest quality, reducing project timelines and minimizing wastage of drug substance is of the utmost importance for our customers with projects in clinical and commercial phases, we have created two specific options at our facilities:
Both facilities utilize either stainless steel and disposable technologies for compounding and storage.
Our biologics services are highly appreciated by our customers. For example, in May 2017, we announced a strategic collaboration with Symphogen A/S Denmark.
Leveraging its more than 140 years of experience in pharmaceuticals, Siegfried provides you with the best knowledge and expertise in our industry to develop your formulations, bringing them through all the clinical phases to the global markets.
With an integrated network of manufacturing facilities in Switzerland, EU and the US, Siegfried offers a set of high quality, customer centric solutions for your biotech and pharmaceutical products.
With Siegfried as your preferred drug product partner, you benefit from contract development and manufacturing as well as co-development with selected partners.
Therefore, whatever your specific drug product requirements are, Siegfried will provide more to exceed your expectations.
Pharmaceutical Development
Oral Solids
With more than 30 years of specialization in the field of solid dosage forms, Siegfried offers a broad palette of pharmaceutical development services. Siegfried’s projects range from products that require difficult formulation, to demanding narcotic or high potency active pharmaceutical ingredients (API), on through to developing robust manufacturing processes and application of new leading technologies. Additionally, we are well experienced in developing second and third generation formulations to support product life-cycle management.
Our Drug Product Development Department consists of two groups based at our Zofingen site in Switzerland: Pharmaceutical Development and Analytical Development. Using leading modern equipment & instrumentation we are well-suited for developing a range of solid dosage forms.
Some examples from our many completed projects include:
Likewise, the development and manufacture of solid dosage forms is offered for high potency APIs (for materials with occupational exposure limits of 1-10µg/m3) in a new, specifically designed and dedicated area.
Besides processing your own active ingredients, we can also provide you with the technical knowledge and support of our Drug Substance custom development & manufacturing which develops those actives for you. One of the many benefits this brings is that the API specifications are pre-determined in early phase, providing harmonization with the formulation required.
For more information about our development capabilities, please contact Business Development.
Steriles & Biologics
Siegfried Development flexible platform offers the development of standard and complex injectable and ophthalmic formulations.
In addition, our development experts support you with:
Clinical trial material for sterile dosage forms is manufactured at our Irvine (USA) and Hameln (Germany) facilities, serving all the countries where your clinical study is carried over.
Analytical Development
Siegfried understands the critical importance of analytical parameters and controls for effective and robust formulations. Our well-experienced Drug Product Analytical Development team works closely with their Pharmaceutical Development counterparts to ensure our customer’s product is fully supported at every phase in the development process. Modernly equipped, we provide the following range of analytical services to help bring your drug product development project and cGMP manufacture to fruition:
Instruments and equipment for analytical investigations
Scale-Up and Clinical Trial Material Production
Siegfried can help you save time and speed up your drug product development with our versatile cGMP pilot manufacturing and scale-up capabilities. Whether you need a formulation in development scaled up into a cost-effective and robust manufacturing process or support with your clinical trial material needs, you can expect more from Siegfried’s pilot manufacturing and scale-up expertise.
We take your process to the next manufacturing stage quickly and smoothly regardless of your starting point, whether it is a new, modified or existing formulation generated by our pharmaceutical development team.
Oral Solids
Siegfried offers drug product Clinical Trial Manufacturing under cGMP conditions at our Zofingen site in Switzerland, certified by SwissMedic and EMA (through mutual recognition). A qualified person releases all manufacturing and analysis for subsequent application and processing.
Because of our versatile breadth of equipment types and size we are able to manufacture clinical trial material at scales ranging from very small quantities to pilot batches, depending on your specific needs, including:
Siegfried also has a separate area for handling high potency substances to manufacture clinical samples and stability batches for APIs with occupational exposure limits of 1-10 µg/m³ under cGMP conditions.
For more information about our Scale Up and Clinical Trial Material Production, please contact Business Development.
Steriles & Biologics
Siegfried offers drug product Clinical Trial Manufacturing under cGMP conditions at our Hameln (Germany) and Irvine (USA) facilities.
Utilizing fix or disposable technologies we’re able to manufacture clinical trial material at scales ranging from 1L.
For more information about our Scale-Up and Clinical Trial Material Production, please contact Business Development.
Process and Analytical Transfer
For a professional and thorough transfer process to take your project or product to the next stage, you can expect more from Siegfried.
From an early development phase, Siegfried plans and designs processes that ensure a successful scale-up and transfer to commercial production.
Oral Solids
Our development and production scale equipment share common design and geometry with a production capacity for all materials, including high potency substances with occupational exposure levels of 1-10 µg/m³. With this consistency in equipment and process type, we ensure an optimal process transfer and scale-up for manufacturing campaigns.
Siegfried supports complete process transfer of your product, either to Siegfried’s Malta site or to the client’s own location.
Services:
For more information about our Process and Analytical Transfer Services, please contact Business Development.
Steriles & Biologics
Siegfried provides flexible and scalable solutions to accommodate a variety of formulation and project requirements for both ANDA and NDA products providing expertise in equipment and process design supporting your project through all phases of manufacturing.
Siegfried supports complete process transfer of your product to our US or EU locations.
Services:
For more information about our Process and Analytical Transfer Services, please contact Business Development.
Commercial Manufacturing and Packaging
Oral Solids
As your flexible partner, Siegfried provides reliable and consistent commercial supply combined with high quality product and performance. We provide versatile cGMP manufacturing capability and robust manufacturing processes that meet your unique market needs.
Siegfried maintains GMP-certified and FDA-audited manufacturing plants for contract manufacturing of oral solids such as granulates, tablets, film tablets and hard capsules filled with powder, granules or pellets.
Small batches are produced in our plant in Zofingen (Switzerland), ideal for orphan drugs or niche products, whereas annual volumes are low. Commercial manufacturing takes place at our production facility in Hal Far (Malta, EU).
Both locations have a multitude of state of the art technologies to manufacture various solid oral dosage forms, including:
We can handle a broad range of batch sizes (0.5kg - 350kg). Our equipment types are selected to match and harmonize with one another, ensuring simple scale-up in case of increasing demand.
Both manufacturing plants have an additional, segregated area to process highly-active and low-dose substances (OEL 1-10 µg/m³) to pharmaceutical dosage forms.
For more information about our manufacturing facilities and their corresponding equipment, please contact Business Development. Whatever your production requirements may be, you can expect more from Siegfried.
Steriles & Biologics
Siegfried offers specialized contract aseptic manufacturing and analytical services for both the pharmaceutical and biotechnology industries. Siegfried Irvine (USA) and Siegfried Hameln (Germany) have know-how and extensive expertise to support small and large scale productions.
Injectable and ophtalmic products are manufactured at Siegfried's Irvine state-of-the-art facility with small scale through commercial batch scale manufacturing capability with 1L-2000L.
With Siegfried's Hameln state-of-the-art facility in Germany, we provide our customers with more capabilities and capacity in the critical field of the parenterals manufacturing, visual inspection and packaging. Our award-winning new facility can produce sterile liquid vials and ampoules, manufactured under aseptic conditions on eight automated RABs protected filling lines, to terminally sterilize them, if needed.
Siegfried supports the value chain for aseptic services from simple to complex formulation exceeding your expectations with unsurpassed service and quality.
Our main capabilities are:
Whatever your sterile production requirements might be, please contact Siegfried. We will be delighted to exceed your expectations.
Marianne Späne
Global Head Business
Development,
Marketing & Sales