Packaging, Quality Control, Storage, Cold Chain

Drug Substance Manufacturing for pre-clinical, clinical and commercial supply
Services and Capabilities 
• BSL 1, 2
• Viral and mammalian seedmaterials (MCB/WCB, MVB/WVB)
• Clinical trial material (phases I–III)
• Commercial manufacturing
• Process validation
• Analytical va...

With over 100 years of leading expertise in biopharmaceutical manufacturing and proprietary technologies, such as own cell lines, an experienced team ensure smooth process development and transfer of your products.

Our end-to-end services include process development, drug substance manuf...

IDT Biologika GmbH provides a wide range of pharmaceutical services which includes sterile dosage filling in vials and pre-filled syringes. With a facility size of 3,600m2, this integrated pharmaceutical/ biological site houses more than 7 filling lines for the aseptic filling of syringes, vials, ampoules ...

Process and Analytical Development

Services and Capabilities
• Tech transfer
• Up- and downstream development
• Formulation development
• Process characterization
• Process optimization
• Development of analyticalmethods 


Technologies 
• Fixed bed & stir...

IDT Biologika is an award-winning company and is proud to have been recognized independently for areas as diverse as vaccines expertise, CDMO services, and facility design. Our pursuit of excellence in these areas is equally what has supported our excellent track record in client and regulatory body inspections.

A complete Fill-Finish solution to streamline your production with unmatched performance and reliability.

Through our vision and mission, we reaffirm our unwavering commitment to advancing global health by addressing the needs in pharmaceutical manufacturing to support our customer’s therapies.

For more than three decades we are working in the commercial filling of biologics and small molecules, such as vaccines, proteins, monoclonal antibodies, biosimilars for leading multinational companies. As end-to-end service provider and with a combination of world-class manufacturing solutions and process excellence, we support you to bring your therapies with the highest quality and speed to market.

You will learn more about:
– Our End-to-End Services covering vials (incl. Lyo) and syringes (PFS)– Our range of fill-finish offerings, including our high-speed filling line for vials– How strategic investments in new technologies allow us to meet the growing industry need for global sterile fill-finish solutions– How we handle the various entry points for customer projects at IDT Biologika

IDT Biologika, a leading global contract development and manufacturing organization (CDMO) for end-to-end services in the development and production of viral vaccines, gene and immunotherapeutics and filling of sterile injectables, appoints Federico Pollano as Chief Commercial Officer effective March 1, 2025.

View the presentation from our Senior Expert Business Development Dr. Nanette Schlatermund about IDT Biologika´s Gene Therapy from Process Development to Commercial Manufacturing

You will learn more about:

– Challenges in AAV manufacturing and how we settle them
– Concepts and strategies for Adeno Associated Virus manufacturing, including almost all requested Analytical Services
– How we handle the various entry points for customer projects at IDT Biologika
– Scale-up from process transfer / development to clinical and commercial manufacturing, including our capacities in drug substance and fill-finish manufacturing

SK bioscience, a global vaccine and biotech company with its headquarters in South Korea, today announced the successful completion of its acquisition of a controlling stake in IDT Biologika, a leading CDMO providing end-to-end services in the development and manufacture of viral vaccines, cell and gene therapy products and aseptic fill-finish of other biologics and sterile injectable products.

Over 100 Years of Expertise and Passion in Advancing Global Health
IDT Biologika, as part of SK bioscience, is a globally operating CDMO that specializes in end-to-end services in the development and manufacturing of biologics, biosimilars and other sterile injectable modalities. 


Our service includes: 
Process & analytical development, drug substance manufacturing from200L to 2,000L, aseptic fill-finish and packaging with all related analyticalservices in-house.

The field of AAV-based gene therapies is rapidly evolving. This applies to aspects such as manufacturing, analytics and regulations which are corecompetencies of IDT Biologika, a full-service CDMO specialized in virus-based therapies and vaccines. In the following, we present insights into our cross-serotype, robust high-yield AAV manufacturing platform. The platform was established with the objective of providing short timelines and a cost-effective scalable process to produce clinical trial and commercial material in up to 2000-liter bioreactors. Current and future areas of process and analytical development are outlined in this presentation.

Inefficient manufacturing processes and small patient populations result in high manufacturing costs. An economical and scalable method for AAV purification can help to reduce these costs. Learn more about IDT Biologika´s platform technology for the purification of AAV particles.

This white paper explains the pitfalls in the development of oncolytic viruses and how to avoid them. 

This Whitepaper provides you with required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).

See how novel technologies can lead to facilitate safe and rapid production.

Cell and gene therapies are growing exponentially across the pharmaceutical field due to their potential to treat and possibly cure a wide range of devastating diseases, including cancer. As these therapies are becoming more wide spread, many drug sponsors are approaching trials with limited knowledge of how to design and launch a successful clinical trial manufacturing (CTM) process. This includes how to strategically investigate and manufacture adeno-associated virus vectors (AAVs) and lentiviral vectors (LVVs), two of the leading viral vectors used for gene therapeutics. Sponsors are faced with a stark learning curve that, without intervention, may lead to high costs, delays, and a failure to bring their drug to patients.