Structural characterization, manufacturing and release of Biotherapeutics and ADCs
Our facility is dedicated to manufacturing, release and end to end services for HPAPIs and ADCs. We have more than 25 years of experience in manufacturing and release of API intended to support all the phases of the clinical development.
Main highlights of the facility include:
- Class D and C area (ISO 7 and 6) and Class B (Iso 5) for final filing and dispensing of ADC sterile solution.
- Separated Class D areas for finishing and dispensing of non-toxic moiety/ API
- Three dedicated and fully separated workshop for ADC, HPAPIs and non-toxic API
- Temperature controlled storage of API (controlled 15-25 °c, 2-8 °C, -20°C)
- Ultra-low temperature-controlled storage (-80°C)
- UHPLC- quadrupole/Orbitrap High-Resolution LC-MS,
- UHPLC- quadrupole/TOF High-Resolution LC-MS with Ion Mobility and
- Triple quadrupole GC-MS along with other equipment.
Inhouse expertise includes:
- End to end services from preclinical to phase III, including analytical development and set up of the release specifications
- Proven and consolidated worldwide Technology Transfers
- Expertise in centralized EMA filing to support Marketing authorization.
Our inhouse technical expertise includes In-depth characterization of recombinant proteins, antibodies, and ADCs including:
- sequence confirmation by LC-MS/MS Peptide mapping
- specialized applications for ADCs: determination of DAR and substitution sites