Scale-up and Technology Transfer
Transitioning a formulation from laboratory feasibility to commercial-scale manufacturing is one of the most technically fragile phases in drug product development. Sponsors frequently encounter challenges such as process non-linearity, raw-material variability, equipment-specific shear/thermal behavior, batch-to-batch inconsistency, and inadequate CPP–CQA linkages. Scale-dependent mixing, aeration, heat transfer, and mass-transfer kinetics can fundamentally alter product microstructure, release profiles, and mechanical properties. Additionally, insufficient process characterization, incomplete risk assessments, and inadequate documentation often impede smooth technology transfer—leading to deviations, OOS/OOT events, extended validation cycles, and regulatory pushback. These complexities become more pronounced for complex generics, 505(b)(2) products, biosimilars, and advanced drug–device combinations, where microstructural fidelity and performance equivalence must be preserved across equipment trains and manufacturing sites.
Healios Labs delivers a scientifically anchored, execution-focused scale-up and technology-transfer framework designed to minimize variability and accelerate manufacturing readiness. Our approach begins with deep process understanding—defining scale-up criticalities through mechanistic analysis, QbD-driven risk mapping, and statistically powered DoE evaluations. We establish robust design spaces, characterize equipment attributes, and translate lab-scale CPPs into plant-appropriate operating ranges while ensuring alignment with regulatory expectations. Our teams develop comprehensive technology-transfer packages including process flow diagrams, master batch records, equipment-mapping matrices, raw-material attribute specifications, scale-up equivalency protocols, and control strategy rationales.
For complex semisolids, injectables, nasal sprays, ophthalmics, biosimilars, and modified-release platforms, Healios incorporates advanced analytical comparability tools, microstructure assessments, in-vitro performance monitoring, and stress-response modeling to ensure product fidelity at every scale. We work closely with your chosen manufacturing partner—domestic or international—to execute engineering batches, optimize mixing/thermal profiles, resolve scale-induced deviations, and support PPQ/validation strategy design and execution.
Healios also manages cross-functional alignment during tech transfer by coordinating analytical method transfer, stability-program transition, cleaning validation documentation, and QMS integration. Our structured governance model ensures transparent communication, rapid issue resolution, and regulator-ready documentation throughout the process.
Healios provides end-to-end scientific, operational, and documentation support to ensure seamless, compliant, and risk-controlled scale-up and technology transfer—driving your program efficiently toward commercial manufacturing.
