Rethinking 'Platforms’ in Cell and Gene Therapy Development

Rethinking the one-size-fits-all model

While some platforms may be working well in specific situations, many CGT teams find themselves needing more adaptability than rigid, off-the-shelf platforms can provide. In those cases, a more flexible framework can offer both structure and freedom without compromising control and process knowledge.

The high variability of CGT programs—from the modality and manufacturing environment to the regulatory pathway—makes it difficult for standardized platforms to serve as a universal solution.

Predefined processes may streamline some steps, but they often require workarounds that increase complexity, introduce delays, or restrict customization. And while speed is critical, so is the ability to pivot as a program evolves. A platform that doesn’t allow that flexibility can quickly become a bottleneck.

Therapies that don’t align perfectly with the platform’s predefined methods may require time-consuming adaptation or even full process redevelopment. This lack of alignment can have broader implications as well. Without built-in mechanisms for flexibility, regulatory filings can become more complex, adding risk at a stage when predictability is critical.

What happens when the process doesn’t fit the program?

These challenges are more than theoretical. Teams working on novel or emerging therapies often find themselves constrained by platforms that weren’t designed to accommodate the biology of their program.

When the process doesn’t fit the therapy, developers are forced to spend valuable time reworking systems or building in exceptions, distracting them from core development milestones and increasing pressure on resources.

Without the right level of adaptability, a platform can shift from being an enabler to an added layer of complexity.

A different kind of platform thinking

Thermo Fisher Scientific’s Rapid Development Framework™ was designed with this challenge in mind, leveraging in-house expertise and tested pathways. Built specifically for the demands of viral vector and cell therapy development, it combines structure with adaptability—providing the benefits of a platform approach without locking teams into rigid workflows.

Rather than an off-the-shelf solution, the Rapid Development Framework is modular and configurable, allowing users to leverage standardized components while integrating their own methods and workflows as needed. Whether the program involves cell therapy or viral vector development, RDF enables teams to maintain control over the process while reducing time, cost, and regulatory complexity.

Designed for both viral vectors and cell therapies

For lentiviral (LV) and adeno-associated viral (AAV) vectors, the Rapid Development Framework provides a proven development path with established raw materials as well as tested processes and analytics that can reduce program cost and accelerate the path to GMP manufacturing, with time to filled GMP drug product in as little as 9 months. For cell therapy developers working on chimeric antigen receptor T cell (CAR-T) or induced pluripotent stem cell (iPSC) programs, RDF supports flexibility across different workflows, with options for automated, semi-automated, or a modular approach (CAR-T) and multiple methods for reprogramming and delivery (iPSC). Established analytical development parameters across both modalities can reduce timelines by up to 50% compared to developing custom assays.* For both cell therapy and viral vector development, the emphasis is on enabling progress—not dictating the terms.

*Custom assay development typically takes up to 12 weeks; RDF requires approximately 6 weeks by leveraging established parameters. 

Save time and cost without sacrificing quality

The value of the flexibility enabled by the Rapid Development Framework ultimately shows up in execution. From early development through regulatory submission, teams can see tangible benefits in time savings, consistency, and process control, including:

• Eliminating the need to start from scratch with pre-qualified materials and standardized analytics
• Supporting project-specific innovation through flexible methods and modular workflows
• Improving documentation and simplifying regulatory filings through thoughtful process standardization

A signal from regulators

Regulatory agencies are increasingly recognizing the value of standardization in complex therapeutic areas. One example is the FDA’s Platform Technology Designation Program—launched in 2023—which is primarily geared toward sponsors and aims to recognize and expedite the use of well-characterized platform technologies in the development of new products. While it does not directly apply to CDMO offerings, the program underscores the agency’s interest in reproducible, efficient development strategies in cell and gene therapy.

The Rapid Development Framework aligns with this direction, by bringing structure where it’s useful, and adaptability where it’s essential. 

Rethinking what a platform can be

In a field where complexity and customization are the norm, the conversation around platform processes is evolving. Developers are looking beyond inflexible, predefined solutions and toward frameworks that offer the flexibility to adapt as science advances.

As the CGT landscape matures, so too must the tools and processes that support it. Whether it’s through regulatory alignment, workflow simplification, or modular design, approaches like the Rapid Development Framework point to a future where speed and adaptability are no longer at odds.

Why it’s time to rethink ‘platforms’ in cell and gene therapy development

In a field where complexity and customization are the norm, developers are looking beyond inflexible, predefined platform processes and toward frameworks that offer the flexibility to adapt as science advances. Thermo Fisher Scientific’s Rapid Development Framework points to a future where speed and adaptability are no longer at odds.