These six high-level workstreams identify, discuss and prioritize key industry topics and challenges swiftly.
The workstreams cover a range of topics, including:
- Analytics and assay validation
- Commercial Readiness and CMC
- EHS and biosafety
- Raw materials
There are unique challenges in this rapidly expanding area
Compared with general biologics, ATMPs (Advanced Therapy Medicinal Products) are immature, with high manufacturing and analytical variability. Science and technology are evolving quickly and regulatory industry guidance needs to keep pace with the speed of development. With the rapid growth of the sector, cross-industry collaboration is critical to solve these common challenges.
Understanding better how processes and technologies impact delivery and patient safety
Members leverage cross-industry expertise via to gain a better understanding of common industry challenges and collaborate to solve problems more quickly. The teams provide an increased network of experts resulting in greater resource to solve challenges.
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.
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