Derisk Multimodal CGT Manufacturing With These Key CDMO Capabilities

By Life Science Connect Editorial Staff

Developers and CDMOs across the CGT landscape are continually exploring how best to manufacture advanced therapies while meeting development timelines and ensuring commercial viability. Whether production can be scaled to meet treatment demand for cancer, autoimmune disorders, and other major indications remains a central concern. Compared with gene therapy, cell therapy manufacturing is notably less mature, more labor intensive, and more susceptible to batch failure. These processes are inherently variable due to differences in starting materials and their dependence on patient-specific inputs.

For CGT developers working across multiple modalities, manufacturing more than one drug with the same CDMO yields a number of benefits, including speed, regulatory consistency, smoother tech transfer, and harmonized quality systems. To succeed, multimodal CDMOs must ensure meticulous contamination control and maintain dedicated SME teams across drug types. As developers evaluate potential partners, it is critical to rigorously assess whether a CDMO has the technical prowess, regulatory understanding, and quality infrastructure required to support manufacture of multiple modalities.

In a recent Cell & Gene live event, experts Steve Award, Principal Director, Supply Chain & Industry X — Life Sciences at Accenture, and Michael Blackton, MBA, VP, Manufacturing and Supply at Ocugen, spoke to their perspective on multimodal CDMO success. Below, we outline their recommendations for prioritization in multimodal CDMO selection.

Expertise Across Modalities

In the evaluation of multimodal CDMO partners, developers must first deduce whether an organization has demonstrable expertise across relevant modalities. Consider asking prospective partners the following:

• Does your team have previous experience manufacturing similar modalities?
• If so, where are those programs in the pipeline, and what were the outcomes of regulatory submissions?
• Do you maintain designated SME teams for different modalities?
• Can your team provide strategic regulatory guidance, including best practices for approval and lot release?

Clear, modality-specific answers to these questions can help distinguish true expertise from nominal capability.

Commitment to Contamination Control, Quality, And Risk Management

To minimize the risks associated with manufacturing multiple modalities in the same facility, a CDMO must demonstrate an organization-wide commitment to contamination control. Red flags include inconsistent application of quality systems across clients, leading to quality drift, or reliance on caution rather than precise engineering controls.

A capable CDMO should have rigorous SOPs, robust documentation practices, and comprehensive employee training programs. Physical segregation of raw materials and error-proofing strategies, such as distinct line fittings for different products, further mitigates contamination risk. Determine whether a CDMO employs an integrated risk dashboard, such as a cohesive manufacturing execution system (MES), laboratory information management system (LIMS), and/or cloud native platform. These systems enable real-time data capture and visibility, empowering cross-functional teams to make in-process predictions, evaluate risks, and implement corrective actions before failure occurs. Whenever possible, schedule a site visit to review these capabilities in person.

Strategic Digital Infrastructure

With a robust network of digital tools, a CDMO partner can predict batch outcomes, manage critical process parameters, and ensure speed and configurability. Evaluate a multimodal CDMO’s technology suite and how effectively it supports advanced therapy manufacturing. While the technology landscape continues to evolve, here are a few strategic offerings to look for:

• Digital twins of facilities. Virtual models of cleanrooms, equipment, quality control, and operator schedules allow CDMOs to test scenarios to improve throughput, enhance flexibility, and increase process confidence.
• Consolidated analytical platforms. Integrated data across scheduling, QC, and logistics provides SMEs with a single source of truth, enabling proactive decision-making and earlier intervention on potential bottlenecks to improve cycle time and control.
• Modular software solutions. Low code, modular platforms offer flexible and cost-effective digital foundations. These systems support automation and continuous data capture, delivering real-time visibility and faster batch release.

A Proven Regulatory Track Record

Finding a multimodal CDMO with established regulatory expertise can be a significant asset. While drug developers must ultimately make their own filing decisions, an experienced partner can provide valuable guidance through complex regulatory challenges. This specialized support is particularly important for nascent developers as they navigate the pathway from academia to regulatory approval.

Developers should ask potential partners about their experience guiding similar modalities through regulatory pathways. Have they supported any commercially approved CGTs? Request proof of execution and governance to evaluate how a CDMO has previously defined success, including batch success, tech transfer performance, and financial or supply chain resilience.

Capacity Planning And Workforce Readiness

Because multimodal manufacturing is so demanding on a CDMO’s resources, capacity planning is a critical factor in meeting development and commercial timelines. Capacity planning is not traditionally GxP, thus, it is rarely audited, making due diligence especially important.

Consider whether a potential partner relies on documented planning processes or institutional knowledge that could be lost with staff turnover. Key questions include whether the CDMO runs capacity models across suites and equipment, simulates different demand scenarios, and can adapt to shifts in commercial demand. With these planning mechanisms in place, a partner will be well-prepared to support multiple modality needs.

In addition, CDMOs should provide dedicated project managers who can deftly navigate the interplay of different modalities while serving as consistent points of contact. The prioritization of regular communication, timeline reliability, and technical depth all contribute significantly to CGT program success.

The Bottom Line Is More Nuanced

Price alone is rarely the defining criteria for whether a multimodal CDMO is the right partner for a CGT developer. Instead, developers must consider a broader set of factors, including contamination control strategies, analytical prowess, digital architecture, and regulatory track records. Together, these attributes drive operational excellence, reduce risk, improve timeline predictability, and ultimately lower COGS over time.