Overview
The goal of technology transfer is to seamlessly transfer product and process knowledge from development to manufacturing, and between manufacturing sites, to achieve successful product realization, as outlined in ICH Q10. This knowledge underpins the manufacturing process, control strategy, process validation, and sustainability improvements. At BioDlink (TOT BIOPHARM), our technology transfer services are designed to address these challenges, particularly when working with CDMOs, where transferring knowledge across different entities can be more complex than internal transfers. Our expert team ensures that all critical parameters are maintained, and product quality is consistently delivered, minimizing risks and accelerating time to market.
Services
-
New product introduction
assessment, including plant equipment suitability, collinear production risk,
and product feasibility risk, etc.
-
Bridging process development and
clinical and commercial production, including intra-company and CDMO technology
transfer (change introduction, raw material list, gap analysis, technology
transfer agreement and protocol, sampling plan, etc.).
-
Process scale-up optimization,
covering pre-clinical trial to clinical production, clinical to commercial
production, and commercial production improvement and problem elimination, with
technical and verification support.
Advantages
-
Experienced core team with over 12
years of experience
-
Standardized technology transfer
management procedure
-
Comprehensive risk management
system
-
Extensive experience in late-stage
process transfer and scale-up
Technology transfer standard management procedure
Core technical staff with 10 years of experience
Comprehensive risk management system
Late-stage process transfer and scale-up experience