Welab’s team can help in the monitoring of small-molecule Chemistry, Manufacturing and Controls (CMC) activities, from candidate selection to the preparation of clinical batches.
Our Synthetic Chemistry team may perform route scouting services to develop the best processes for scale up of compounds coming from previously developed in house Medicinal Chemistry projects or of any other Active Product Ingredient (API). Routes can be scaled-up to the 100 g scale and the corresponding Technology Transfer Reports (TTRs) may be prepared. These may be then transferred for further scale-up to suitable Contract Development and Manufacturing Organizations (CDMOs).
Our Analytical Chemistry experts provide, as well, a quick transfer of the analytical information available (stability studies, compound characterization, physicochemical characterization, solid form selection) to the CDMOs.
We provide follow up activities on both the Drug Substance (API) and the Drug Product (formulated) amounts needed for clinical phases. This is done in collaboration with suitable CDMOs, either selected by the client or from the wide Welab’s network, either in Spain, Europe, US, or Asia. We perform synthetic, analytical, and regulatory (through external collaboration) expert monitoring and we offer also the writing of the CMC-related documentation regulatorily needed for the clinical assays, such as the Common Technical Document (CTD) or the Investigational Medicinal Product Dossier (IMPD).