GMP Manufacturing
ABL Europe
ABL Europe SAS is a pure-play GMP CMO, completely dedicated to the provision of viral vector GMP contract manufacturing services, with a particularly strong technical & regulatory track record in process development, scale-up & GMP manufacturing of oncolytic and immunotherapeutic viral vectors, used in all phases of clinical development performed globally.
ABL Europe’s experience provides its clients with:
- Drug substance, drug product & comprehensive QC testing capabilities in-house
- Validated aseptic production of non-sterile filterable viral vectors
- Phase 1 – 3 GMP supply, including pivotal efficacy studies
- Process development, characterisation and validation
- Analytical development, qualification and validation
- CMC section content for phase 1 – 3 clinical trials, including product approval applications
How can we help you?
With addition in 2017 of a brand new 200 L / 500 L SUB facility in Strasbourg and the acquisition of a state-of-the-art 6,500 m2 GMP manufacturing site in Lyon in 2018, ABL’s expansion has further strengthened its position in the GMP viral vector CMO market to support clients with a long term manufacturing strategy able to meet their clinical development & product registration objectives.
Process Validation
ABL draws on its expertise & experience to design production processes that optimize product yields, minimize regulatory risk & speed the time to clinic.
Quality Control
ABL Europe has a particularly strong in-house analytical function providing a wide range of viral vector product specific QC methods in addition to generic pharmacopeia procedures.
GMP Manufacturing
With a brand new 200 L stirred single use bioreactor (SUB) facility, ABL has strengthened its position in the GMP viral vector CMO market to support clients
Fill / Finish
ABL Europe provides viral vector aseptic drug product manufacturing services in-house using a Bausch and Straubel filling machine located in a rigid isolator.
