Shanshan Liu, Technical Director at No deviation Pte. Ltd. and an International Board Member of ISPE, will be sharing her expertise at the QSMI Biennial Scientific Conference 2024 & 4th Asian Rabies Advisory Group of Experts (ARAGE) Meeting held at Samyan, Bangkok; Thailand.
The presentation, “New Modalities & Emerging Technologies,” explores the rapidly evolving landscape of Advanced Therapy Medicinal Products (ATMPs) and their associated challenges and innovations. It highlights significant breakthroughs, such as the approval of 40 ATMPs to date under FDA jurisdiction.
Despite the exiting opportunities ATMPs present. There are also various key challenges commonly presented to bringing the therapies to the patient. Those challenges include delivery systems, regulatory complexity, manufacturing scalability, affordability and high development costs.
With the new modalities, inclusive of Antibody Drug Conjugate, new vaccines, gene therapies and cell therapies, the product complexity increases, so does the manufacturing process complexity. Among all the challenges, the challenges around the manufacturing of the ATMPs will be specifically discussed.
Throughout the presentation, the generic manufacturing processes for mRNA vaccine, viral vector gene therapy product and CAR-T product will be discussed to review the opportunities and challenges uniquely presented to those new therapy types.
To address the new manufacturing processes and their specific challenges, ATMP products also require new process systems and with different process systems, the facility and operation should planned and implemented accordingly. This presentation will provide commonly considered process systems and the pros and cons for different solutions.
Specific examples will be provided on the emerging technologies, where integrated solutions, digitalisation and robotic technologies are adopted for the manufacturing of ATMP products.
Lastly the presentation also examines point-of-care (POC) manufacturing as a promising yet distinct approach. While sufficiently different from centralized manufacturing, POC solutions must complement rather than undermine traditional systems.
Overall, the presentation underscores the need for robust strategies to address the complex landscape of ATMP development while leveraging emerging technologies to improve affordability, scalability, and patient outcomes.
We look forward to Shanshan’s participation at the QSMI Biennial Scientific Conference 2024, where her expertise will undoubtedly inspire innovation and collaboration in the field of advanced therapies.
Are you ready to explore the possibilities of ATMP manufacturing? At No Deviation, we are dedicated to helping organizations navigate the complexities of advanced therapies with innovative solutions and expert guidance.
Contact us today at hello@nodeviation.com to learn more about how we can support your journey in advancing ATMP manufacturing and delivering better outcomes for patients.
With 15 years of experience in the pharmaceutical industry globally, predominantly in Process, CQV, Process Automation and Project Management, Shanshan has held both consultant and end user roles.
With increasing involvement in the GMP remediation and GMP audit projects, she has been building in-depth compliance knowledge as well as interaction with authorities globally.
