Abiozen specializes in efficiently transitioning super generic APIs from research and development to full-scale commercial production. Our streamlined tech transfer and scale-up protocols are designed to ensure process reproducibility, regulatory alignment, and operational readiness—enabling faster time-to-market without compromising on product integrity or compliance.

Seamless Transition from Lab to Plant

Our technology transfer framework is built on detailed documentation, robust validation protocols, and cross-functional collaboration. Drawing from Thermo Fisher CRDMO’s integrated R&D-to-manufacturing approach, we ensure a smooth handover from development teams to production lines, maintaining consistency in quality, yield, and process control throughout the scale-up lifecycle.

Technology Adaptation for Scale

We adapt and optimize technologies to align with client specifications and plant infrastructure. Leveraging Curia Global’s expertise in tech transfer, we ensure that equipment compatibility, batch design, and process parameters are tailored to support high-volume production while preserving critical quality attributes. This adaptability is key to ensuring successful scale-up across diverse formulations and dosage forms.

Global Regulatory Alignment

Our teams provide regulatory support throughout the technology transfer process, ensuring all processes, validations, and documentation comply with regional and international requirements. Aligned with Thermo Fisher Patheon’s scale-up services, this integrated approach facilitates faster market entry and regulatory approvals, while ensuring sustained compliance across jurisdictions such as USFDA, EMA, TGA, and PMDA.

Accelerated Commercialization with Consistent Quality

By aligning process engineering with regulatory and operational frameworks, Abiozen enables rapid, reliable commercialization of super generic APIs. Our focus on reproducibility, compliance, and scalability ensures that every transfer not only delivers technical success—but also strategic commercial advantage.