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IDT Biologika

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End-to-End Contract Pharmaceutical Development and Commercial Manufacturing Services

With passion, we bring pharmaceutical solutions to life.

Address
Am Pharmapark,
06861 Dessau-Rosslau,
Germany
Phone
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IDT Biologika is a global biopharmaceutical contract development and manufacturing organisation (CDMO) specialising in vaccines, gene and immune therapeutics, and the fill-finish of other sterile injectables. With more than 100 years’ expertise across various vaccine platforms, we integrate cutting-edge innovations in advanced therapies to provide tailored solutions that help our customers advance their products.

We have been providing innovative technologies, world-class manufacturing solutions, scientific expertise and process excellence for more than 30 years. Our end-to-end services include process development and validation, drug substance manufacturing up to BSL-2, sterile fill-finish, labelling and packaging, as well as quality control and analytics.

IDT works to help pharmaceutical and biotechnology companies develop and commercialise therapeutic products, allowing patients worldwide to benefit from life-saving treatments. By leveraging our experience and forward-thinking approach in collaboration with the world’s leading biopharma companies, we build impactful partnerships that drive progress and deliver meaningful results for patients worldwide.

Comprehensive pharmaceutical development and analytical services

IDT Biologika performs all our analytical services in-house and ensures seamless integration from early-stage development to clinical and commercial manufacturing, delivering flexibility, regulatory compliance, and the highest standards of quality at every step. Our commitment to operational excellence is reflected in our best-in-class processes and good manufacturing practice (GMP) manufacturing, which meets US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Brazilian Health Regulatory Agency (ANVISA) standards.

For viral vaccines and viral vector-based gene therapies, we offer the whole value chain, including own cell lines and manufacturing platforms.
To our state-of-the-art facilities, through to continuous investments, belongs one of the fastest isolator filling line for vials in the world.
Small and large-scale manufacturing for vials, including lyophilisation.
Long-term experiences in complex processes for syringe fill/finish projects.
All our quality control services are available in-house, including a quality control development department with broad experience e.g. adventitious virus testing via NGS.
Manual, half-automated and fully automated visual inspection capabilities.
Secondary packaging lines for vials, syringes, with track and trace, single, multi and combination products.
Multiple warehouse with different temperature zones, even for -30°C; all warehouses are temperature-controlled and equipped with emergency services.
ESG principles guide our decision-making, fostering trust and value creation. Having received the EcoVadis Gold Medal in 2024, we belong to the top 5% of EcoVadis sustainable assessed companies.

Our in-house analytical services cover the entire lifecycle of your product, from early process development through scale-up to commercial manufacturing, ensuring consistency and comparability of data at every stage. We combine technical expertise, advanced early and late-stage manufacturing capabilities, a secure supply chain, and a proven track record of successful global product launches.

By selecting the most advanced technologies and applying our deep expertise, we develop scalable, efficient processes tailored to your needs. If you are ready to move directly into GMP manufacturing, we seamlessly transition into that phase.

Permanent cell lines for pharmaceutical development

IDT Biologika specialises in the most common permanent cell lines (both adherent and suspension) and offer our own regulatory-approved, pre-characterised cell lines. Using our cell lines enables a fast GMP start while leveraging our existing investments.

Vaccines and gene and immune therapeutics hold great potential for combatting infectious diseases and addressing major global health challenges such as cancer, neurological disorders, and genetic diseases. This growing demand has fuelled an increasing need for viral vectors.

For decades, we have been working with viral vectors, and our experts have extensive experience in developing cell culture technologies, virus production, and associated analytical services. This includes complex upstream, downstream, and formulation processes.

High-quality fill-finish services for injectable products

For more than 30 years, IDT Biologika has collaborated with leading multinational companies in the fill-finish of vaccines and other sterile injectables. By integrating innovative technologies, world-class manufacturing up to BSL-2, and process excellence, we deliver flexible, high-quality solutions for filling vials and pre-filled syringes.

Preventing contamination is especially critical when handling live agents, particularly during changeovers. To mitigate risks, we prioritise the use of single-use equipment. All visual inspection services are conducted in-house to ensure that every batch meets stringent GMP guidelines. We also offer high-performance automated visual inspection alongside manual and semi-automated inspection options.

Our dedication to environmental, social and governance (ESG) principles is embedded in everything we do, guiding our decision-making process and fostering trust, as well as long-term value creation. This commitment has been recognised through our UN Global Compact membership and the EcoVadis Gold Medal 2024. Driven by passion, innovation and a commitment to excellence, we strive to make a meaningful impact on global healthcare by helping our customers bring their products to market.

About IDT Biologika

Founded in 1921, IDT Biologika currently employs 1,600 colleagues and operates two BSL-2 manufacturing sites. We have received more than €600m ($628m) in investments since 1993, including €400m ($419m) since 2011, and have been involved in more than 200 development, clinical and commercial projects in recent years.

For more information about IDT and its services, please contact us today via the enquiry form on this page.

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Address
Am Pharmapark
06861 Dessau-Rosslau
Germany

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