Containment in HPAPI manufacturing: A lifecycle approach
Jan-Klaas Blomme, assistant production manager at Ajinomoto BioPharma Services, details why HPAPI containment must be fully integrated
The elevated potency of high potency APIs( HPAPIs) is intrinsically associated with stringent toxicological thresholds, frequently resulting in occupational exposure limits( OELs) in the low ยต g / m 3 range or below. Consequently, the risk profile extends beyond operator exposure alone as even trace residues can represent a critical cross-contamination hazard that may compromise product quality and ultimately patient safety. In this context, conventional handling approaches are no longer sufficient for these compounds.
HPAPI manufacturing at a CDMO therefore requires a robust and fully integrated containment strategy to protect personnel, product quality and patient safety across all operational phases and throughout the entire product lifecycle. Safe, compliant HPAPI manufacturing is thereby not treated as a discrete asset or isolated capability, but as an integrated system that aligns safety, quality, and operational performance from early development through commercial supply.
This approach goes beyond incremental upgrades of personal protective equipment( PPE). It is founded on a comprehensive containment strategy combining engineered controls with robust operational and organisational measures to ensure sustainable containment performance.
Beyond toxicological assessment
Ajinomoto BioPharma Services, for example, applies occupational
Laboratory at Ajinomoto high potency facility
exposure banding( OEB) systematically to categorise substances into defined exposure bands based on their potential health hazards. OEB classification supports the consistent selection and implementation of a standardised containment strategy, particularly when a compound-specific OEL has not yet been established.
At project initiation, APIs and relevant intermediates undergo a comprehensive inhouse toxicological assessment. The resulting data are used to assign the appropriate OEB with a corresponding containment performance target( CPT) and to derive specific health-based exposure limits.
These parameters provide the basis for design and implementation of the engineering and operational controls. As a result, high potency product handling can be governed by well-defined workflows in which engineered containment forms the primary layer of the containment strategy, while operational controls ensure consistent and compliant execution.
From a CDMO perspective, this approach supports an accelerated project execution and high manufacturing reliability by embedding a scientifically grounded and risk-based containment strategy from early in the project, thereby reducing late-stage redesign, deviations and avoidable operational constraints.
Containment strategy
The hierarchy of controls should prioritise engineering controls over operational measures to achieve effective, reliable exposure
18 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981