IDT Biologika - Contract Manufacturing and Development of Viral and Bacterial Vaccines

The production of vaccines on contract is offered as a complex service, starting with development stage right through to large-scale production. Live vaccines are one focus of interest.

IDT vaccines are either produced as recombinant vector vaccines, based for instance on pox virus vectors, or produced as attenuated live vaccines. In addition gene–manipulated bacterial organisms have been used for the production of vaccines.

IDT is a global leader in MVA technology and develops new technologies for many innovative and promising new vaccines, including tuberculosis, AIDS and malaria.

HUMAN VACCINE–CLINICAL TRIAL PRODUCTION

IDT is leading in clinical trial production of human vaccines – over 20 different vaccines have been handled to date. In addition IDT provides comprehensive services for the development of large–scale production methods (pilot plant). Further services provided include:

• Manufacture of culture mediums, cell cultures and buffers
• Virus production and inactivation
• Production of bacterial antigens
• Formulation
• Fermentation
• Fill and finish of vials and bottles (0.1ml– 500ml)
• Lyophilisation
• Labelling and final packaging

EMERGENCY RESERVE VACCINATION DOSES

IDT is one of the few companies worldwide with the capacity for large-scale campaign manufacture of a wide variety of vaccine products. Our flexible manufacturing technology allows us to manufacture new products with exceptionally short lead times.

As a result, 60 million emergency reserve vaccine doses were manufactured by IDT. Production steps take place in clean-rooms with cGMP classification in two state-of-the-art manufacturing buildings with a total area of 6,000m².

The recently inaugurated production complex is one of the most modern vaccine production assets worldwide, equipped with highly innovative technologies. Due to the building's modern and efficient design it is referred to as the ‘Factory of Glass’ and was awarded the international ‘Facility of the Year’ 2008 in the category ‘Operational Excellence’.

VALUES FOR USERS, CELL CULTURE AND BACTERIAL APPLICATIONS

IDT has access to the most modern state-of-the-art technologies for the production of vaccines:

• Virus production: - Robot systems for the aseptic processing of roller bottles (up to 1,000 roller bottles/batch) including disposable fomenters for Microcarrier and suspensions, and contained sterile processing systems

• Cell Cultures: - Laser systems for processing SPF-eggs restricted access barrier system (RABS) and robot systems for the aseptic processing of roller bottles (up to 1,000 roller bottles/batch)

• Bacterial production: -fermentors (5 L– 800 L, IsolatorS. and contained sterile processing systems

At the customer's request IDT will also develop new technologies for vaccine production.

CLINICAL PHASE TO COMMERCIAL PRODUCTION

In collaboration with renowned research partners worldwide, new vaccines are developed and manufactured for customers. This begins with clinical phase one and continues until commercial production.

The following development services are provided:

• Cell line development
• Upstream process development
• Downstream process development
• Media optimisation
• Formulation studies
• Process development and optimisation
• Development of analytical methods