Oral Solid Dosage Forms
Based on its experience in Drug Product development and manufacturing since 1873, Siegfried offers a broad range of pharmaceutical development services. Products requiring difficult formulations, to demanding narcotic or high potency active pharmaceutical ingredients (API), on through to developing robust manufacturing processes and application of new leading technologies. Additionally, Siegfried is well experienced in developing second and third generation formulations to support product life-cycle management.

Siegfried's Drug Product Development Department is based in Barberà del Vallès (Spain) and consists on Pharmaceutical Development and Analytical Development. Using leading modern equipment & instrumentation, Siegfried is well-suited for developing an extensive range of solid dosage forms. 

Some examples from our many completed projects include:

• Tablets using unstable APIs
• Rapid release tablets for poorly soluble APIs
• Hard capsules with delayed release (pellets, mini-tablets)
• 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 below 10 µg/m3) in a specifically designed and dedicated area. 

Besides processing APIs provided by the customer, Siegfried supports you with the technical knowledge of in-house Drug Substance custom development & manufacturing which develops or optimizes those actives for you. One of the many benefits 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.

Sterile Injectables & Opthalmics
Siegfried Development flexible platform offers the development of standard and complex injectable and ophthalmic formulations.

In addition, Siegfried development experts support you with:

• Evaluation of primary packaging materials
• Selection of the right filtration system
• Identification of the best mixing and dosing system (e.g. 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, Siegfried provides the following range of analytical services to help bring your drug product development project and cGMP manufacture:

• Active ingredient characterization and preparation of specifications (e.g. intrinsic dissolution, particle size, polymorphic form, NMR, IR, UPLC and HPLC-MS, GC-MS, X-ray etc.) linked to Siegfried's analytical capabilities in Drug Substance.
• Development of analytical methods and specification preparation for the finished Drug Product incl. microbiological methods
• Validation of analytical methods (in-house developed as well as external methods)
• Stability screening (incl. forced degradation and photostability investigations) for the selection of the final formulation and the primary packaging material 
• Support, adaptation and optimization of customer's methods
• Analysis of highly-active substances and formulations (cGMP-compliant)

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 Barberà del Vallès (Spain), certified by national and international authorities. A qualified person releases all manufacturing and analysis for subsequent application and processing.

Siegfried offers cGMP-manufacturing of all scales ranging from very small quantities to pilot scale batches depending on your specific needs, including:

• Blending 
• Granulation (wet and dry)  
• Pellet extrusion and spheronisation  
• Fluid Bed Processing (top and bottom spraying)
• Tablet compression 
• Pan Coating 
• Hard gelatin capsule filling 
• Handling of high-potent APIs with occupational exposure limits below 10 µg/m³

For more information about our Scale Up and Clinical Trial Material Production, please contact Business Development. 

Sterile Injectables & Ophthalmics (small Molecule & Biologics)
Siegfried offers drug product Clinical Trial Manufacturing under cGMP conditions at our Irvine (USA) and Hameln (Germany). 

Utilizing fix or disposable technologies Siegfried manufactures clinical trial material at scales ranging down to 1 l. 

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
Siegfried's 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 below 10 µg/m³. With this consistency in equipment and process type, Siegfried ensures an optimal process transfer and scale-up for manufacturing campaigns.

Siegfried supports complete process transfer of your product, either to Siegfried’s own site or to a location selected by the customer.

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
• Packaging according to customer specifications
• Stability testing according to ICH
• Support in registration activities
• Life cycle management

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

Sterile Injectables & Ophthalmics (small Molecules & 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
• Packaging according to customer specifications
• Stability testing according to ICH
• Support in registration activities
• Life cycle management

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

Commercial Manufacturing

• Oral Solids 
• Injectables
• Ophthalmics
• Inhalative Products 

Commercial Packaging
Siegfried is equipped for all the Drug Products manufactured to pack primary, secondary and tertiary in ready-to-market configurations using state-of-the-art equipment in accordance with all cGMP and customer- and market-specific requirements. Serialization and aggregation according nearly all relevant national requirements is available and will constantly updated based on the proceeding requirement changes. Siegfried's special expertise is to perform packaging as primary brite stock followed by a secondary country-specific packaging of splits of the primary batch. UV-encoding of brite stock is used as standard technique for bottles and vials to ensure compliant operations. This approach offers to the customer maximal flexibility and cost-efficient packaging operations for worldwide supply especially of niche and small-scale products.

Siegfried is suppling Drug Products packed ready to market worldwide.

• OSD and inhalative product
  • Primary Packaging (standard API and highly potent API)
    • HDPE Bottles
    • Blisters (hot and cold-form), including on-line blister printing and anonymous blister, Peel-off blister
  • Secondary Packaging
    • Labeling of bottles (serialized)
    • Tamper evident serialized folding boxes (automated addition of devices available)
    • Blister printing
    • Wallet packaging
  • Tertiary packaging
    • Bundling and aggregation
    • Shipper case packaging and pallet aggregation
• Ophthalmics
  • Primary Packaging 
    • Bottles (BTC), PFS, cartridges, vials
    • Tubes (tin, alu, laminated foil)
    • Preservative-free bottles (Novelia^®, Aptar^®)
    • Vials, pre-filled syringes, cartridges
  • Secondary Packaging
    • Labeling of bottles
    • Tamper evident serialized folding boxes (automated addition of devices available)
    • Pouch packaging 
    • Overcapping
  • Tertiary packaging
    • Bundling and aggregation
    • Shipper and pallet aggregation
• Injectables
  • Primary Packaging 
    • Vials and Ampoules
    • Cartridges
    • Pre-filled syringes
  • Secondary Packaging
    • Labeling of Vials and Ampoules
    • Packaging in thermoformed shells and tamper evident serialized folding boxes 
  • Tertiary packaging
    • Bundling and aggregation
    • Shipper and pallet aggregation