Contract- or Co-Development and Manufacturing

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)

Siegfried can help you save time and speed up your sterile 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 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 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 to ensure successful scale-up and transfer to commercial production.

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.

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.