Process development

ABL Europe can adapt the development strategy to work with clients, meeting their corporate objectives.

Often for Biotech companies in early stage clinical development, speed-to-clinic following a risk managed path is the key driver to demonstrate human proof of concept & reach funding milestones.

Whereas in the later stages of product development and planning for pivotal efficacy trials, the CMC section content needs to be expanded and further defined to support process characterisation and validation studies, required for market approval.

A key element of a successful process development phase, is to have product specific analytical tools readily available from the outset, which ABL can establish in-house.

Manufacturing processes are transferred for further optimisation or can be developed from scratch, depending on the client’s starting position.

Using materials and small scale equipment representative of adherent and suspension GMP operations, ABL brings it’s viral vector bioprocessing expertise to steer projects to a successful scale-up outcome.

ABL’s process engineers and operators, follow the process from the bench, through engineering demonstration runs into the GMP facility.

The joint project team mitigate project risk on an informed data-driven basis, adjusting the work plan as necessary in mutual collaboration.