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:

• Tablets using very unstable APIs
• Rapid release tablets for poorly soluble APIs
• Hard capsules with delayed release (pellets, minitablets)
• Matrix tablets with delayed release
• Oral disintegrating tablets (ODT) 
• Chewable tablets

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:

• Choice of the right primary packaging materials
• Selection of the right filtration system
• Identification of the best mixing and dosing system (eg peristaltic or rotary piston pumps)
• Study of production material and packaging interactions with your compound (leachables and extractables)
• Evaluation of terminal sterilization effects 

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.

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:

• Active ingredient characterization and preparation of specifications (e.g. intrinsic dissolution, particle size, polymorphic form, NMR, IR, UPLC and HPLC-MC, etc.) in close collaboration with the Drug Substance Analytical Development Department.
• Development of analytical methods and specification preparation for the finished medicinal product 
• Development on microbio methods
• Stability screening (incl. forced degradation and photostability investigations) for the selection of the final formulation and the primary packaging material 
• Validation of analytical methods
• Support, adaptation and optimization of customers’ methods
• Analysis of highly-active substances and formulations (cGMP-compliant)

Instruments and equipment for analytical investigations

• HPLC Systems (UV / DAD, Agilent, Waters)
• DryLab Software for computer-supported HPLC method development 
• GC System (Agilent) 
• Dissolution systems for manual sampling (Sotax, Distec)
• Dissolution systems for online measurements (UV-VIS, Sotax, Agilent)
• Dissolution systems with automated sampling (Sotax, Pharmatest)
• Degasser, heater, filler and dispenser instruments for dissolution media (DosaPrep)
• UV-VIS spectrophotometer (Agilent)
• Tablet hardness tester (Erweka) 
• Dissolution tester (Erweka) 
• K.F. titration 
• Particle size analysis (Malvern)
• LIMS system management

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:

• Intensive mixing and wet granulation 
• Fluid bed granulation/drying
• Roller compaction
• Single pot granulation (also suitable for organic solvents and hot-melt granulates)
• Tabletting via instrumented rotary presses (incl. minitablets)
• Pellet extrusion and spheronization
• Film coating of granulates, pellets or tablets
• Filling of hard gelatin capsules with powder mixtures, pellets, minitablets, fluids

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.

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:

• 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
• Organization of the packaging according to customer specifications
• Stability testing according to ICH
• On-site support with implementation at the manufacturing plants
• Trouble-shooting and problem solving 
• Support in registration activities
• Life cycle management

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:

• 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
• Organization of the packaging according to customer specifications
• Stability testing according to ICH
• On-site support with implementation at the  manufacturing plants
• Trouble-shooting and problem solving
• Support in registration activities
• Life cycle management

For more information about our Process and Analytical Transfer Services, please contact Business Development.

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: 

• Power blending
• High shear mixer
• Fluid bed systems with top and bottom spray (Wurster)
• Roller Compaction
• Tablet presses with bi/trilayer capability
• Perforated drum film coater
• Hard Shell Capsule lines for powder, granules, pellets and minitablets filling
• Blister lines for thermoform and cold form blister packaging, including Aluminium/Aluminium

 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:

• Aseptic Filling:
  • Biologics and Chemical
  • Solutions
  • Suspensions
  • Emulsions
  • Creams
  • Ointments
  • Gels

• Container Closures:
  • Vials
  • Ampoules
  • Dropper Tip Bottles
  • Syringes
  • Cartridges
  • Squeeze tubes
  • Screw Cap Bottles
  • Pre-Filled Syringes (PFS)

• Combination / Drug Delivery Devices:
  • Drug Coated Implants
  • Drug Delivery Devices
  • Sustained Release Delivery Systems

Whatever your sterile production requirements might be, please contact Siegfried. We will be delighted to exceed your expectations.