Personalized medicine holds immense potential for transforming healthcare by supplying tailored treatments to each patient, but the manufacturing process faces obvious challenges. Overcoming these hurdles requires a specific set of solutions. By addressing these challenges, the process of manufacturing personalized medicine becomes streamlined, providing patients with targeted and effective treatments quickly, which significantly improves patient outcomes.
The ATMP Journey
Each year, ATMP trials contribute to more than $23 billion in investments. Strong technology foundations and flexible solutions are what make the difference in patent exclusivity, expanding operations to clinical trials, and a speedy time to market. Classified into three main categories, gene therapies, somatic-cell therapies, and tissue-engineered medicines, the ATMP journey’s future focus is on implementing agile and flexible systems to allow for swift adaptation and scalability across the rapidly evolving landscape.
Key challenges affecting your ATMP Journey
Data management & time to market
Real-time release impeded by manual activities, lacking qualified automation, inefficient line and product change over, and an inability to achieve digital technology transfers.
Process complexities & scaling
Costly scaling efforts due to higher number of SKUs and smaller batch sizes. Complexity of manufacturing ATMP exacerbates issues.
Workforce effectiveness
Dependency on tribal knowledge impedes the spread of key skills and amplifies risks of manual activities.
Regulatory compliance
Disparate and disorganized data impedes alignment with regulatory bodies to ensure product quality and reporting to enable Right to Operate.
Conquer challenges with a holistic digital strategy
Digitization allows new technologies and ideas to be tested quickly and at less cost than what could be done before. Take advantage of new technologies that promote flexible, scalable manufacturing in the world of personalized drug development.
Explore more about Advanced Therapeutic Medicinal Products
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