IDT Biologika - Contract Manufacturing and Development of Vaccines and Pharmaceuticals

For more than 85 years, IDT has developed and manufactured sterile medicinal products, especially biological products. This experience makes IDT a competent and recognised provider of outsourcing solutions. The focus of our outsourcing activities is the contract manufacture and development of sterile liquid pharmaceuticals including lyophilisation, viral and bacterial vaccines.

The facilities for vaccine and pharmaceutical development and production are completely separated. Both business units support pharmaceutical and biotech companies with a wide range of contract services, including development from an early stage, aseptic filling, final packaging and quality control.

PREFILLED SYRINGES, VIALS AND AMPOULES INCLUDING LYOPHILISATION

The scope of the pharmaceutical contract manufacturing business unit is the manufacture of parenterals including freeze-dried products. IDT has proven expertise in lyophilisation (vials and ampoules) and the filling / packaging of prefilled syringes.

Our product portfolio includes biopharmaceuticals, narcotics and high-viscosity products, in addition to conventional drugs.

We handle the following formats on a production area of 3,500m²:

• Syringes: 0.5ml - 5ml
• Vials: 2ml - 30ml
• Ampoules: 1ml - 10ml
• Bottles: 50ml - 500ml
• Lyophilisation vials / bottles: 2ml - 50ml
• Lyophilisation ampoules: 1ml – 10 ml

Our new packaging facility, with 2,000m², enables us to label, blister and package virtually all the above mentioned formats on several state-of-the-art lines.

DEVELOPMENT SERVICES FOR STERILE PRODUCTS

IDT offers supporting services for pharmaceutical and biopharmaceutical drug development and new product launches, such as handling stability studies and support in regulatory affairs. We can develop formulations, develop and validate analytical methods, and develop and optimise processes (including lyophilisation).

We can also carry out product optimisation, stability tests, follow-up studies, validation of processes and regulatory services.

CONTRACT MANUFACTURING OF VIRAL AND BACTERIAL VACCINES

IDT’s extensive experience, gained over many years of developing and producing immunobiological preparations, is used as a basis by the vaccine business unit to produce vaccines that conform to the requirements of current GMP-guidelines for third parties.

Nowadays, IDT is involved in the contract manufacture of human vaccines for clinical trials, from clinical phase 1 to commercial production. IDT provides a complex service for the production of viral and bacterial vaccines as follows:

• Manufacture of culture mediums, cell cultures and buffers
• Virus production and inactivation
• Production of bacterial antigens
• Formulation
• Fermentation (5L – 800L)
• Fill and finish (0.1ml - 500ml)
• Lyophilisation
• Large-scale production

The vaccines are manufactured in two state-of-the-art production plants with a total area of 6,000m². Over the last ten years, we have manufactured more than 20 different human vaccines for our customers.

DEVELOPMENT OF INNOVATIVE HUMAN VACCINES

The vaccine business unit is also responsible for the contract development of analytical methods, processes and technologies for numerous innovative human vaccines.

In collaboration with research partners and pharmaceutical companies worldwide, new vaccines are manufactured for use against diseases such as AIDS, malaria, tuberculosis and smallpox. The following services are provided:

• Cell line development
• Upstream process development
• Downstream process development
• Media optimisation
• Formulation studies
• Process development for filling and freeze-drying
• Development of quality control strategies and methods