OSD
Successful OSD development requires more than solving the immediate formulation challenge. Decisions made during development can influence analytical requirements, process robustness, stability, scale-up and ultimately how effectively a product can progress towards filing, tech-transfer and commercial manufacturing. When these activities are considered separately, technical risks may only become apparent later, potentially resulting in additional development work, increased resource requirements or delays.
This eBook explores how a connected, science-led approach can help you build product and process understanding earlier and use that knowledge to make better-informed decisions throughout development. It looks at the role of predictive development, QbD, material characterisation, analytical insight and targeted experimental work in understanding sources of variability and focusing development effort where it provides the greatest value.
It also considers the later stages of the development pathway: how to keep filing and commercial requirements in view, build scale-up and tech-transfer readiness into development, and retain scientific and process knowledge as a product moves towards larger-scale manufacturing. Finally, it examines how external development support can complement internal teams when additional capacity or specialist formulation, analytical or manufacturing expertise is required.
Read the eBook to explore:
- Why formulation, analytical, process and manufacturing decisions need to remain connected
- How predictive, data-driven development can build product and process understanding
- How analytical evidence can inform formulation and process decisions
- What to consider early to prepare for filing, scale-up and tech-transfer
- How development partners can provide additional capacity or specialist support while maintaining continuity towards commercial manufacturing
To read the eBook, please complete the form below.