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March 08, 2024

In the evolving cell and gene therapy market, when it comes to selecting your contract development and manufacturing organization, one size does not fit all. As many biotech and biopharma companies depend on experienced cell and gene therapy contract development and manufacturing organizations (CDMOs), selecting a CDMO partner that best fits your needs and is “just right” is critical. Here are some key factors to consider that can significantly impact the success of your program(s).

Facility Adaptability

Having ready-to-go, customizable and hoteling manufacturing space options allows sponsors the necessary flexibility to adapt to changing manufacturing needs without delaying your program. Considering that cell and gene therapy clinical development is often expedited, it is essential for sponsors to select a CDMO with pivotal and commercial supply experience and capacity.

Economic Development Support

CDMOs that have economic development support benefit greatly and that advantage is passed along to the developer. The policies and incentives for success provide an environment that promotes growth, innovation and technology adoption.

Ample Human Capital

Access to reliable and ample human capital depends on the location of a CDMO’s facility. Choosing a CDMO located near a rich pool of talent from a variety of sources, such as academic institutions and universities, research centres, and medical centres, provides a consistent supply of professionals.

Talent Development and Retention

Talent development that focuses on specialized skill development through a comprehensive, scalable training program ensures the workforce is proficient for a variety of roles.

Additionally, CDMOs that are located in a limited competitive environment, combined with a positive work culture that fosters employee engagement and provides career advancement opportunities, leads to high retention, facilitating a stable and reliable manufacturing workforce.

Manufacturing Reliability

Building a culture with a mindset focused on quality and continuous improvement enables consistent delivery of superior products that meet quality and regulatory standards. In-house and on-site quality control can provide further benefits, especially for autologous therapies, such as enhanced control, reduced cost and shorter turnaround time, leading to earlier patient treatment.

Flexible, Secure Supply Chain and Logistics

CDMOs that have a dedicated logistics hub and cold chain distribution partner available in the location where clinical trials are taking place offer options to enhance efficiency and secure on-time product delivery to distribution and clinical sites.

Finding Your Goldilocks

Selection criteria to secure your Goldilocks’ CDMO partner in the dynamic cell and gene therapy space needs to extend beyond capacity expansion and track record, offering you sustainable operational excellence. Your CDMO partner should not only meet your immediate needs, but also provide the necessary flexibility and security for a long-term, dependable partnership – with an organization that is equally invested in your success.

To learn more about OmniaBio, a dedicated and flexible global cell and gene therapy CDMO, and how we can help bring maturity to your programs, please visit our website here.

 

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