Our expertise and our capabilities in aseptic fill-finish of a broad range of liquid and lyphilized products complement our cutting edge technology and committment in development and drug substance manufacturing.
- Fill-Finish of Biologics & Sterile Injectables
- Innovative Biologics, MAB’s, Recombinant Proteins
- Small Molecules
In our European and US facilities we provide for sterile liquid and lyophilized drug product manufacturing of a broad range of large and small molecule products.
We employ our technologies and expertise to meet customer needs, covering clinical phase 1-3 and commercial filling into vials and pre-filled syringes. We have a variety of filling lines and all the associated fill-finish and packaging technologies suited to different volumes and project specifics in the GMP-compliant and BSL-2 facility.
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.