At the Advanced Therapies Congress 2024 in London, Amina Al-Mossawi, a Qualified Person (QP) at Hitech Health, delivered vital insights on the crucial considerations for biotech firms when selecting a Contract Development and Manufacturing Organisation (CDMO). With extensive experience in both clinical and pharmaceutical settings, Amina’s guidance is invaluable for companies aiming to navigate the complex landscape of cell therapy manufacturing.
During her presentation, Amina emphasised the importance of aligning with a CDMO that meets the specific needs of a therapy from development through to commercialisation. She also explained that this alignment proves crucial to the success rate of new therapies in the highly competitive and rapidly evolving biotech industry.
Understanding the Full Scope of CDMO Services
Amina also pointed out that a competent CDMO must fully grasp the intended purpose of the therapy and the demographics of the patients it targets. This deep understanding proves critical for developing, scaling up, and managing the commercial supply chain of new therapies. She further stressed the importance of technical proficiency, particularly in adhering to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
The Financial and Strategic Stakes of CDMO Selection
“Selecting the right CDMO involves more than evaluating technical capabilities,” Amina stated. As a result, financial considerations and strategic planning play pivotal roles. Thus, biotech firms must prepare to manage unexpected costs and complexities, such as those arising from Brexit and other regulatory changes.
Risk Management in CDMO Partnerships
In particular, A significant portion of Amina’s speech addressed the risks associated with miscommunication and the dangers of partnering with CDMOs that do not tailor their services to meet client needs. “Clear, realistic communication and expectations form the foundation of any successful partnership,” Amina advised.
A Call for Tailored CDMO Services
Hitech Health is advocating for a shift away from the ‘one-size-fits-all’ approaches prevalent in the CDMO industry, urging companies to seek partners that offer flexibility and customisation. This tailored approach ensures that the unique needs of each therapy and patient group are met, thereby enhancing the potential for clinical and commercial success.
If you’d like to arrange a meeting with Amina to learn more about our services then please email: aal-mossawi@hitech-health.com
Reference : https://personalizemymedicine.com/2024/04/18/advanced-therapies-congress-2024/