Sterile Dosage Filling and Lyophilization

Sterile Dosage Filling and Lyophilization

Products
Sterile Dosage Filling and Lyophilization
Sterile Dosage Filling and Lyophilization

Information

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 and injection/infusion bottles including lyophilization. This facility has the capability to handle both small-scale and large-scale production - with the flexibility to scale-up as demand grows. Bulk solutions can be prepared in mobile vessels up to 500L. Stationary vessels are used for larger bulk volumes up to 4,000L. The facility runs state-of-the-art cGMP and has been the subject of numerous regulatory audits. Contact us for more information.
Main Categories
APIs (Active Pharmaceutical Ingredients)Contract Services - Analytical & Lab Services
All Categories
APIs (Active Pharmaceutical Ingredients)Contract Services - Analytical & Lab ServicesSera and Vaccines
Distribution areas
North America (USA, Canada)East Asia (e.g. China, Japan, Korea)Europe - EU countriesEurope - non EU (e.g. UK, Russia, ex-CIS countries)South Asia (e.g. India, Pakistan, Sri Lanka)South East Asia (e.g. Thailand, Philippines, Singapore)
Supplied from
United States
IDT Biologika GmbHIDT Biologika is a global biopharmaceutical contract development and manufacturing organization that specializes in the production of innovative live viral vaccines, viral vectors for gene & immune therapeutics, oncolytic viruses, virus-like particles as well as fill/finish of other sterile liquid and lyophilized biologics to improve human health worldwide. We offer 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 manufacturing,Fill/Finish, secondary packaging, quality control/analytics and storage. IDT Biologika handles every step in manufacturing and packaging of small clinical batches as well as of products in a large-scale commercial scale. On request of our clients we supply their products in vials, pre-filled syringes (with and without safety devices), autoinjectors or as combination products. In Rockville, MA, USA we utilize broad capabilities and a depth of technologies for process development and manufacturing of clinical trial material for phases I-II. At its headquarters in Europe, IDT Biologika operates one of Europe's premiere integrated facilities for end-to-end services from process development through clinical phases I-III to commercial manufacturing. Our fully integrated services are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (up to BSL2) manufacturing capabilities meeting EMA and FDA standards (ANVISA ready). Many human vaccines developed by IDT Biologika, together with international partners, are already in use, fighting infectious diseases such as COVID-19 Tuberculosis, AIDS, Malaria, Cancer, Dengue and Ebola.

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