IDT Biologika: Providing Specialized CDMO Services
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IDT Biologika: Providing Specialized CDMO Services

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Prof. Dr. Ulrike Fiedler, Senior Vice President Commercial, IDT BiologikaProf. Dr. Ulrike Fiedler, Senior Vice President Commercial
Modern technologies and increased government intervention have positioned vaccines as a crucial and prestigious facet of the global pharmaceutical market, one that is undergoing significant growth. However, with the rise of manufacturing live viral vaccines and viral vectors, there is a high demand for innovative drugs, complex molecules, and biologics manufacturers that calls technology capabilities and manufacturing expertise. Further, with COVID-19, there’s a high demand for capacities at short notice, and quality requirements set and focusing resources on core interests, which has in turn given rise to the manufacturers’ need for specialized contract development and manufacturing organizations (CDMOs). That’s where IDT Biologika comes into the picture. “We believe there is an important role for specialized CDMO services in the vaccine industry. CDMOs specialized in handling vaccine development and manufacturing processes such as IDT Biologika will run ahead and offer the required know-how and expertise combined with the required equipment and processes,” says Prof. Dr. Ulrike Fiedler, senior vice president commercial at the company.

IDT Biologika specializes in innovative live viral vaccines and gene and immune therapeutics, and continuous investments to adapt capacities to the rising demands. Being a specialized CDMO services provider, it can foster development and manufacturing activities for complex active ingredients (live viral vaccines and gene therapeutics) and new technologies. With the availability of a wide variety of manufacturing technologies, expert project teams at IDT Biologika works closely and collaboratively with partner companies to provide customized support and guidance every step of the way. They are dedicated to providing solutions that cover the clients’ diverse needs. “Our project teams have the technical acumen to leverage multiple complex platforms addressing development and manufacturing of even the most complex vaccines and biologics,” mentions Dr. Ulrike. As such, it is a no brainer that the medium-sized CDMO located in Dessau-Rosslau, Germany (Headquarter), and in Rockville, MD, IDT Biologika is trusted by governments and internationally in the biopharmaceutical industry as they possess almost 100 years of expertise in innovative vaccine development and manufacturing. The organization showcases reliability, high flexibility, and experience with a broad range of technologies in the manufacturing of vaccines and other biological products. For governmental businesses IDT Biologika has been providing emergency use vaccines for more than 15 years.

As of today, IDT Biologika is supporting with high effort and engagement the development and manufacturing of COVID-19 vaccines with multiple partners worldwide to supply them as soon as possible

IDT Biologika is strongly committed to supporting its clients in fighting infectious diseases, cancer, and other diseases worldwide. “Our company is unique in its ability to accommodate all services from process development to manufacture and analytics of viral vaccines, gene, and immune therapeutics and other biological products,” mentions Dr. Ulrike. IDT Biologika offers the entire value chain in contract manufacturing, from process development through clinical phases I-III to commercial manufacturing, including drug substance manufacturing, filling, visual inspection, quality control/analytics, packaging, and cold storage. The handling of a product through the entire manufacturing process guarantees high safety as well as high speed for the product.

For more than 15 years, IDT Biologika is involved in the development and production of new human vaccines against various infectious diseases. These new human vaccines are developed with internationally known partners and cover, for instance, tuberculosis, AIDS, malaria, Lassa fever, dengue fever, and Ebola. Some of them are already in use, fighting infectious diseases. IDT Biologika has also been actively supporting the worldwide supply of new vaccines in pandemic situations. “As of today, IDT Biologika is supporting with high effort and engagement the development and manufacturing of COVID-19 vaccines with multiple partners worldwide to supply them as soon as possible,” states Dr. Ulrike

Due to the strong growth in demand for high-quality manufacturing services for biotechnological products, especially in the area of therapeutic and prophylactic vaccines, IDT Biologika has recently invested in a new drug substance facility. “Within the next two years, we will continue to invest in additional commercial API production and Fill/Finish capacities as well as in new manufacturing technologies. Moreover we will focus on the introduction of large scale-commercial manufacturing of gene and immune therapeutics,” says Dr. Fiedler. In order to offer clients the entire value chain from drug substance and drug product manufacturing to packaging for commercial and for clinical trial materials, the company also recently added internal packaging capacities for clinical trial materials for phases I-III. “The development and continuous investment in innovative manufacturing technologies are important ongoing activities. We focus on developing new and efficient analytical and manufacturing technologies for viral vectors and gene and immune therapeutics,” mentions Dr. Fiedler. Especially in pandemic situations, IDT Biologika is providing constant support and responding flexibly and at very short notice to new demands. For the future, IDT Biologika will continue and increase its efforts in providing those short term needed vaccines to the patients to fight infectious diseases worldwide.
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Company
IDT Biologika

Headquarters
Rockville, MD and Dessau, Germany

Management
Prof. Dr. Ulrike Fiedler, Senior Vice President Commercial

Description
A global biopharmaceutical contract development and manufacturing organization (CDMO) specializing in the production of innovative live viral vaccines, viral vectors for gene and immune therapeutics as well as fill/finish of sterile liquid and lyophilized biologics to improve human health worldwide. The company offers clients in B2B business a single source CDMO partner at our sites in Germany and the USA, with seamless end-to-end solutions and the ability to nimbly scale projects from development through to commercialization. This includes process development, drug substance manufacture, drug product manufacture, packaging, quality control/analytics and storage

IDT Biologika