Sterile Injectables
We specialize in the production of sterile liquid and lyophilized drug products, handling a wide range of both large and small molecule products. By leveraging our expertise and advanced technologies, we meet the diverse needs of our customers, supporting clinical phases 1 to 3, as well as commercial filling into vials and prefilled syringes.
- Fill-Finish of Sterile Injectables
- Innovative Biologics, MAB´s, Proteins & Enzymes
- Antibodies
- Biosimilars
- Small Molecules
Aseptic Fill-Finish
Our facility is equipped with multiple filling lines and all associated fill-finish, and packaging technologies, tailored to different volumes and project specifications, all within a GMP-compliant and BSL-2 environment.
This includes advanced isolator filling lines for mid- and large-scale projects. These isolators maintain the highest sterility standards, ensuring drug integrity and the safety of both patients and operators by creating a robust barrier against contamination. They fully comply with stringent regulatory requirements for sterile processing (EU Annex 1). Our commitment to consistent high-quality manufacturing makes us a trusted, long-term partner for our customers.
In order to keep up with market demands and new therapies, we have expanded our capacities by another high-speed filling line.
With batch sizes up to 500,000 vials, this line is one of the fastest in the world and can serve up to 100 million vials per year. The line can handle both BSL-2 and other liquid products and contains a fully automated visual inspection, own air filtration and H2O2 decontamination and inactivation systems.
Our high-speed filling lines are state-of-the-art and benefit from ongoing investment in upgrades and expansion. They have an excellent track record of client inspections and are approved by the FDA, EMA, and ANVISA.
Quality Control & Regulatory Support
Aseptic vial filling and lyophilization of biologic pharmaceuticals are supported by a full range of analytical services and regulatory expertise at IDT Biologika. We support our clients with the extensive regulatory expertise that comes with being one of the world’s leading biologics manufacturing companies, helping to prepare CMC documents and complete all the required filings with relevant authorities.