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.
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.
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:
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.
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 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.
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.
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.