The increasing use of accelerated regulatory pathways is helping promising new therapies reach patients more quickly. However, it is also placing greater pressure on pharmaceutical development programmes, particularly those involving highly potent active pharmaceutical ingredients (HPAPIs).
HPAPI programmes require specialist expertise and stringent controls to protect employees, products and the environment. When timelines are compressed, decisions around process development, containment, manufacturing strategy and regulatory requirements must be made earlier and often with limited information. Careful planning from the outset is therefore critical to avoiding delays, managing risk and supporting successful scale-up.
In a recently published article for Speciality Chemicals Magazine, Rabiaa Berkous, Project Manager – Development Programmes at CARBOGEN AMCIS, explores how HPAPI programmes can be managed effectively under accelerated timelines.
Drawing on CARBOGEN AMCIS’ extensive experience, Rabiaa highlights the importance of early programme evaluation, robust project management and close collaboration between multidisciplinary teams. She also explains how continuous communication and an integrated approach can help anticipate technical and regulatory challenges, enabling complex projects to progress efficiently from early development through to GMP manufacturing without compromising safety or quality.
Read the full article and find out more here
