HIGH POTENCY APIS capabilities, timelines, regulatory expectations and geographical considerations.
One of the first priorities during this stage is to assess the categorisation of the API and its intermediates, to confirm how and where compounds can be handled safely and appropriately. At this stage, the Categorisation Team( CAT), together with toxicology and safety experts, becomes closely involved in the assessment process.
Using available toxicological and pharmaceutical data, together with dedicated assessment tools, the CAT estimates the Occupational Exposure Limits( OELs) from Acceptable Daily Exposure( ADE) values and determines the appropriate category level for the compound, as shown in Figure 1. Compounds are generally considered highly potent from Category 3 onwards.
Once categorisation is confirmed, selecting the most appropriate development and manufacturing site becomes a critical part of programme planning. This decision is typically based on several factors, including containment requirements, available resources, projected API volumes and any specific technology or equipment needs.
For organisations managing HPAPI programmes, access to multiple facilities with varying containment capabilities can provide important operational flexibility, particularly if programme requirements or projected commercial volumes evolve during development. A structured project management process is also essential to ensure that project objectives, costs, timelines and quality expectations are clearly defined and managed throughout development.
During project initiation and proposal preparation, the scope of the programme is evaluated according to the customer’ s requirements and development strategy. This generally includes assessment of:
• The development phase
• Projected API volumes
• GMP or non-GMP manufacturing requirements
• Timeline expectations
• Analytical & production requirements
At this stage, it is important to identify the activities, resources and expertise required to support the programme successfully. Development plans and associated timelines should also take into account any customer constraints related to clinical or regulatory milestones.
Moving into execution
Once a programme moves into execution, a dedicated project manager typically coordinates activities across the technical and operational functions involved, including process R & D, analytical development, production, quality assurance and regulatory affairs.
Internal kick-off meetings are valuable for ensuring alignment across teams before programme activities begin, followed by customer kick-off discussions to confirm responsibilities, timelines and communication processes. As programmes move on, the project manager is responsible for monitoring timelines, budgets and overall progress against agreed objectives.
Clear, transparent communication among all stakeholders is particularly important during development programmes. Regular project meetings help maintain alignment and support rapid decision-making as timelines, priorities or development strategies evolve.
Development programmes often encounter unexpected technical or operational challenges, such as process modifications, analytical issues, revised manufacturing forecasts or changes to clinical strategy. Effective project management therefore depends not only on maintaining schedules but also on close cross-team collaboration to resolve issues quickly and adapt development plans where necessary.
The development of new APIs frequently involves activities across multiple projects, sites and external partners over several years, depending on clinical progress, regulatory requirements and the impact of expedited development pathways.
JUL / AUG 2026 SPECCHEMONLINE. COM
23