Aesica provides full API development and cGMP scale-up manufacturing services for clinical and small-scale commercial supply.
Our development facilities support manufacture of quantities sufficient for both pre-clinical and early clinical studies (i.e. up to Phase I) via our development lab and scale-up facilities, while our scale up laboratory and pilot plant allow us to manufacture API quantities sufficient to support advanced clinical trials (Phases II & III) and beyond. Regulatory and quality requirements are fully embedded into our systems, enabling us to support you completely through every phase of your development activities.
We also operate fully compliant analytical laboratories in which we develop and validate methods to cGMP to support the manufacture and clinical supply of APIs to cGMP. Our facilities area also fully equipped and registered to handle both potent and controlled drugs.
We determine and define both the Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs) for all of our API processes using a combination of traditional and modern techniques, including Design of Experiments (DoE).Our expertise in the area of process optimisation ensures high levels of product quality and compliance every time.
All development work is focused on creating a bespoke process that is fit for purpose at the relevant scale. All work is performed in line with our standard operations and procedures all of which are audited regularly by our customers and regulatory bodies.