Process development
The development of a drug is not only an expensive and resource-intensive process it is also an incredibly complicated journey from the beginning to the end. A well-developed process provides greater knowledge and reduces the risk of failure, both in terms of substance and medicinal effect. The greater the robustness of the process the quicker to market, the greater the quality and cost-effectiveness of manufacturing and supply. At Magle Chemoswed we not only understand these challenges but strive to deliver processes that are optimal, scaleable, and deliverable from early phases through to commercial supply.
Our integrated group of scientists provides a seamless transition for API and drug substances from the initial discovery stages of the program to deeper process development. Our teams have extensive experience in route or step rebuild, process optimization, and impurities assessment and synthesis.
Organic chemistry
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 development
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.
Pre-formulation
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.
Capabilities
- Hydrogenation
- Particle Track, Particle View and React-IR probes
- Bench/lab-scale reactors
- Lyophilization
- Vial Filling
- Autoclavation
- Radley’s™ Reactor System provide automated and controlled development reactions.
Talk to one of our specialists
Ellen Sölver
Ellen has a Master in Chemistry and has worked as a Research and Development Chemist within Magle Chemoswed since 2000.
