This workstream is defining an inter-company strategy, accepted by major regulatory bodies, on process characterization. This strategy will bring quantifiable benefits in terms of time and resource savings.
An optimal approach for designing and performing process characterization studies is required
As industry moves towards next generation therapeutics, manufacturing processes are becoming increasingly advanced and novel. This increases the importance of standardizing and streamlining process characterization (PC) activities.
Failure to adequately characterize processes may result in:
- risks to patients
- inability to meet regulatory compliance requirements
- delays to registration
- sub-optimal batch yields
- extended processing times in plants
- costly commercial batch failures impacting supply to patients
- diminished company revenues
Defining a strategy to minimize time and resources required for process charaterization studies
This workstream is defining a consensual inter-company strategy, accepted by major regulatory bodies that reduces time and resource for process characterization without impacting on product quality or patient safety. Members are defining how the use of prior knowledge across programs and within programs can narrow and focus Process Characterization studies.
This work will support the development of a consolidated approach to conducting risk analysis, reducing risks of non-compliance to regulatory requirements and increasing consistency of process performance. This will minimize the time and resources required to execute process characterization studies without compromising robust data and process model and reduce restrictions around established conditions.
Process Characterization deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
To find out more about how BioPhorum can help your business, enter your details below and a member of our team will be in touch.