Our development experts can assist in lead candidate developability assessment. We provide a full review and development planning servicing, including milestones for early synthesis testing and early preclinical material generation. We specialise in optimizing the discovery – development interface and assist on planning for phase dependent development plans and the needed supporting documentation.
Lyophilization cycles are not “one-size-fits-all,” and extensive cycle development is needed for each product. This includes a series of studies to understand the freezing and drying behavior of formulation components as well as investigations into how formulation strengths or containers affect the freeze-drying process. We specialise in niche scale lyophilization development.
We can help in identifying formulation strategies and also design and manage critical preformulation studies such as salt screening, form screening, pH solubility studies, solubility in solvents and drug-excipient compatibility studies to help secure the best formulation candidates moving forward.
Ellen has a Master in Chemistry and has worked as a Research and Development Chemist within Magle Chemoswed since 2000.