Process characterization – supporting registration and commercialization
The Lifecycle of Biopharmaceutical Drug Development
Process characterization is a critical activity during the lifecycle of biopharmaceutical drug development, allowing effective process control strategies to be developed for successful process validation and commercial manufacture. Through the experience gained in the execution of late stage process development programs, FUJIFILM Diosynth Biotechnologies has developed a suite of Quality by Design (QbD) tools and documentation templates for the benefit of our customers. Our approach allows flexibility to construct a process characterization study designed around your specific process and needs.
We deliver a first-in-class Process Characterization (PC) program design and execution to support your product registration and commercialization strategy.
We deliver a first-in-class Process Characterization (PC) program design and execution to support your product registration and commercialization strategy. These services can be included as part of your product and process development lifecycle. We also offer process characterization studies as a free-standing service.
- We use uses a rational approach to Process Characterization using QbD tools.
- QbD is a continuum not a step function – Many traditional pharmaceutical development approaches are consistent with QbD having some aspects of science and risk based approaches.
- PC programs are designed with the depth (e.g. small, med, large) needed to meet client process requirements while also balancing timeline and resource needs versus risks and benefits.
Benefits of a using QbD tools in PC
Utilizing a QbD approach will provide greater process understanding which allows to better define an appropriate control strategy leading to lower manufacturing costs from greater efficiencies and fewer failed lots. It also reduces the risk of failure in process performance qualification campaigns.
Having a well-designed Process Characterization Study also will provide you with:
- Additional data with which to assess deviations.
- More efficient and effective change control.
- Increased value to the development and product package especially if subsequently licensed onto big pharma / biotech who often have in-house QbD programs.
There can also be regulatory benefit including being able to meet increased expectations e.g. FDA Process Validation Guidance 2011 and FDA Draft Biosimilar Guidance 2012.
Typical activities in a Process Characterization Study
- CQA Identification and FMEA Analysis
- Analytical method qualification
- Unit Operation Screening and/or DoE studies
- Intermediate & media stability studies
- Resin and Membrane reuse
- Robustness and/or Linkage Studies
The latest high-throughput technology, including ambr® systems and Tecan robotic workstations, together with high-throughput analytics, are routinely applied allowing for increased data collection.