IDT Biologika - Contract Manufacturing and Development of Sterile Liquid Dosage Forms

IDT has more than 85 years experiences in the development and manufacturing of sterile and biological products, making the company a competent and recognised partner for parenterals based on both small and large molecules. They have special competencies in aseptic fill / finish of prefilled syringes and lyophilisation in vials and ampoules.

IDT operates one of Europe's premier integrated pharmaceutical and biological contract manufacturing and development facilities for sterile liquid dosage forms, with expertise and quality controls to supply world markets. As a one-stop shop IDT provides contract services from early stage development to commercial production.

Most of our state-of-the-art facilities, which are EMEA and FDA-inspected, are equipped with innovative technologies and have been built since 2003. As a member of the Klocke Group we can provide access to the network of other Klocke companies, specialised on contract manufacturing of solid forms and cytotoxics.

Sterile filling and lyophilisation capabilities

With a facility size of 3,600m², the integrated pharmaceutical and biological site houses more than seven filling lines for the aseptic filling of syringes, vials, ampoules and injection / infusion bottles. As well as four freeze-driers for vials and ampoules.

This facility has the capability to handle both small-scale and large-scale production, with the flexibility to scale-up as demand grows.

The following filling capabilities are provided:

• Syringes 0.5 –3ml
• Vials 2 –30ml
• Ampoules 1 –10 ml
• Bottles 50 –500ml
• Lyophilisation: Vials 2 –50ml
• Ampoules 1 –10ml

Biopharmaceuticals, narcotics and sterile drugs

Our focus on sterile liquid dosage forms means we have developed excellent expertise and personnel in the broad range of disciplines that are required for optimal execution of a project. We have cutting-edge experience in technically sophisticated projects such as biopharmaceuticals, including leadership in the emerging area of biosimilars, lyophilized compounds and narcotics.

Especially for bio-technically manufactured products formulated in syringes and freeze-dried applications in vials or ampoules, we have cutting-edge experiences to support your projects. Because IDT also produce vaccines, the quality control is optimally equipped for the special requirements of such products.

Narcotic manufacture and freezing

Another focus of IDT is the manufacture of narcotics. The production (including storage) of these drugs demands high requirements. IDT is one of the few companies worldwide which has in addition the capability to freeze dry narcotics.

Development services, clinical trials and optimisation

IDT has the expertise and the critical personnel required for rapid, successful completion of the development phase. We offer a full-range of services for the clinical trial phase as well as stability tests, follow-up studies and optimization.

Throughout our development activities, IDT is an expert in the compilation of quality documentation for the establishment of application dossiers. We have a perfect track-record of providing the required documentation for our client's projects. At the end of the development process, we assist you in the transition of your projects to full-scale manufacturing.

IDTs development services:

• Formulation and process development
• Development and validation of analytical methods
• Clinical trial filling and packaging
• Post-trial optimization
• Transfer to commercial production
• Assistance in regulatory affairs