Partnerships to Build Success

September 10, 2025 by Aldevron

The value of working with an expert CDMO from discovery and preclinical onward

This is part three of a three-part series summarizing our whitepaper, Set Your Cell and Gene Therapy Program Up for Success from Day One

Our previous posts, Understanding the Risk and Heading In the Right Direction, explored the size and nature of the risks involved if a developer doesn’t plan for clinical and commercial stages during early-phase cell and gene therapy development. In this post, we’ll outline how a good partner can mitigate those risks.

Translating cell and gene therapies from biological concept to scalable and manufacturable treatment involves significant costs and complications that can threaten a treatment’s commercial viability. Many CGT developers, particularly at early stages, lack the in-house expertise to meet stringent Chemistry, Manufacturing, and Controls (CMC) requirements or the capacity to develop and manufacture CGTs at scale in a cost-effective manner.

Focusing on CMC
Unlike traditional drug review processes, where 80% of the regulatory review focuses on the clinical portion, around 80% of the CGT review process is centered on product manufacturing and quality, according to the FDA.

Therefore, CMC data is crucial for regulatory approval. Developers need to demonstrate consistent and safe manufacturing through quality control, stability tests, and evidence of reproducible scaling for therapy production.

CMC considerations must be integrated into the CGT development program from the start. This encompasses the design, qualification, operation, and maintenance of the manufacturing facility and its supporting functions. For smaller biotechnology and academic developers, generating this evidence can be challenging in the early stages of development.

CGT-specialized end-to-end CDMOs can support such developers. With years of experience and deep expertise, CDMOs use highly automated, high-throughput technology and workflows to eliminate manual tasks that cause errors and delays, ensuring adherence to the highest manufacturing standards. CDMOs often employ single-use bioreactors, proprietary vector platforms, and the latest gene-editing techniques to enhance manufacturing capabilities.

Investing in expertise and experience
Building a relationship with a CGT-specialized CDMO in the earliest stages of preclinical development is a valuable investment for the success of your program, given the significant risks associated with quality, scale-up, and regulatory issues later in clinical development.

By partnering with a CDMO from the beginning, developers can achieve more efficient transitions between program phases and optimize preclinical stages for later-stage challenges, such as scale-up or scale-out activities. An experienced CDMO will also help ensure the consistency of materials and processes, and provide phase-appropriate quality grade materials, analytics, and regulatory support.

Access to specialized expertise in CGT manufacturing is crucial. Without it, developers risk delays, missed opportunities, and escalating costs, especially during later stages that require manufacturing at scale. Partnering with CGT-specialized CDMOs brings substantial benefits, such as:

• Many years of experience and deep know-how
  These CDMOs typically have a proven track record with multiple CGT programs and unique access to the limited talent pool, capable of understanding and rapidly troubleshooting emerging issues.
• Expertise in regulatory affairs and compliance
  Experienced CDMOs often have open lines of communication with regulatory bodies, enabling right first-time submissions and smoother regulatory reviews.
• Analytical testing resources
  They possess the tools and resources to conduct the robust analytical testing required to maximize the safety and quality of therapy.
• Comprehensive CMC experience
  CDMOs with a strong portfolio of successful CMC submissions increase the chances of regulatory approval.
• Experience with process optimization and scale-up
  Their experience in process optimization and scale-up allows for efficient and effective manufacturing transitions.
• True end-to-end capabilities
  Leading CDMOs offer a full spectrum of knowledge, technology, and techniques needed to bring a novel CGT to market in an efficient, cost-effective way while maintaining the highest safety and efficacy standards.

As an example, Aldevron offers a full spectrum of services to support CGT programs from small-scale, preclinical work to clinical trials and commercial scale. With over 25 years of experience in the industry, we have a deep understanding of the evolving regulatory landscape. That expertise can guide you through complex regulatory requirements while maintaining compliance at every stage.

By partnering with Aldevron, you gain access to a wealth of experience, cutting-edge technology, and a commitment to quality, maximizing your CGT program’s chances of success. We are dedicated to supporting you through every phase of development, helping you to navigate challenges and achieve your commercialization goals efficiently and effectively.

Learn more about setting your program up for success with our whitepaper

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