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Assess your sustainability practices, identify areas for improvement, and seamlessly integrate them into production.
Optimize waste management by implementing innovative recycling techniques. Use energy recovery and carbon capture initiatives to improve energy and material use.
Achieve energy, water, and space savings to build an effective operation with a greener footprint.
Build a comprehensive SUT library that dictates the whole project.
Reduce complexity with standardized single-use diagrams.
Plan for scalability from R&D to full-scale production.
Select the right materials for your process with an effective URS.
Create a naming convention optimized for speed and accuracy.
Design your process to be efficient and scalable from the start.
Standardize documentation for consistency and efficiency.
Develop and deliver training programs on compliance and best practices.
Conduct internal audits to ensure continuous compliance.
Free up your operators time and improve your designs.
Stay ahead of regulations with thorough GMP risk assessment and mitigation.
Develop a risk-based URS around your project's unique requirements.
Embed best practices into your project with expertly developed and managed SOPs.
Develop and manage BOMs from a single source of truth.
Ensure your Master data is uploaded in full.
Implement efficient inventory management practices to reduce waste.
Coordinate logistics to ensure timely delivery and reduce delays.
Qualify vendors and communicate effectively from the start.
Optimize supply chain processes to cut costs and streamline logistics.
Bring your E&L qualification program up to date with current regulatory expectations.
Mitigate supply chain risks with SU dual sourcing.
Assess your supply chains for sustainability goals.
Ensure your materials are fit-for-function for your process needs
Ensure your materials will be delivered on time.
Implement innovative recycling techniques and optimize waste management.
Large biopharmaceutical multinational
Monoclonal antibody
Qualification
Problem
Needed to de-risk commercialization schedule by bringing completing E&L qualification in unprecedented short timelines with limited resources. There was a lack of in-house E&L knowledge that meant this hefty workstream was not started early enough. This issue was escalated very high up and was in the spotlight at above-site leadership teams. A fast and effective E&L qualification approach was needed to keep the project on track.
Solution
The company used Fastnet to rapidly implement a science-based approach in a traceable GMP format, which enabling quality to perform facilitated reviews. The risk of leachables was significantly reduced by applying principles outlined in Margarian et al (2016). Only materials of constructions and surface areas of SUT located downstream of UFDF presented a risk to patient.
Result
The project was delivered in record time with limited resources. All involved received superb recognition for preserving the commercialization milestones of the product. The approach used would go on to be adopted at the global level across all sites.
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