ElevateBio

Powering the creation of cell & gene therapies at a speed the world deserves.

Clinical Development

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The best time to engage a cell and gene therapy CDMO is when key process development decisions are still being made, not once your process is ready for GMP manufacturing. Early manufacturing input reduces risk, accelerates technology transfer, and improves manufacturability and process consistency from the start.

Most Programs Engage Their CDMO Too Late

When we ask when the right time is to engage a CDMO, the answer we hear most often is, “Once the process is ready for technology transfer”. Nobody wants to pull a busy technical team into CDMO conversations before there’s a process ready to hand off. But by then, the decisions that shape manufacturability, scalability, and operational success are already locked in. A process that performs well in the lab can still hit real problems once it moves into GMP manufacturing.

Manufacturing Experience Matters More Than Capacity

Facilities, equipment, and people are the obvious assets a CDMO brings to the table. The more valuable one is manufacturing experience, the practical knowledge of how a process actually performs in a GMP setting. The right time to draw on that expertise is during process development, not after the process is locked, so the process gets designed with manufacturability in mind from the start.

A CDMO Sees Manufacturing Risks a Development Lab Can’t

A CDMO can tell you things a development environment can’t. Equipment reliability is one: how often does that piece of equipment generate errors when it’s run over and over, batch after batch? Raw materials and vendors are another: does the vendor provide robust quality control, and are they a supply partner you can actually count on? Timing matters too. An unstable intermediate that has to be prepared just in time can take longer to process on the GMP floor than it did on the lab bench. And in-process test results, the ones that trigger decisions like seeding, splitting, or harvesting, need a home: on the manufacturing floor or in the QC lab.

The Right CDMO Shapes Your Process, Not Just Manufactures It

The right question when evaluating a cell and gene therapy CDMO isn’t whether they can manufacture your process. It’s whether they have the process development capability to engage before the process is even defined. A CDMO brought in at the point of clinical manufacturing inherits your constraints. A partner engaged during process development helps you avoid creating them in the first place, so your program never loses momentum handing off from development to manufacturing.

ElevateBio Integrates Process Development and Manufacturing From the Start

ElevateBio offers a strong integrated tech transfer team that includes SMEs from manufacturing operations, MSAT, and process development. They provide critical manufacturability design input to the process development effort upfront, rather than a manufacturability assessment after the fact that points out what’s wrong with a process that’s already been transferred. This early engagement doesn’t just derisk and accelerate tech transfer. It also reduces variability, and failures in clinical manufacturing.

Yogesh Waghmare, Senior Director, MSAT

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Yogesh Waghmare, PhD is Senior Director of Manufacturing Science and Technology at ElevateBio, where he leads end-to-end technical support for GMP manufacturing of advanced modalities including cell therapies, viral vectors, and mRNA. With over 15 years of experience across MS&T, process development, and CMC leadership, he has held senior roles at Moderna, Editas Medicine, bluebird bio, and Sanofi-Genzyme, supporting clinical through commercial programs and regulatory submissions. Yogesh holds a PhD in Chemical Engineering and has authored numerous publications and delivered invited presentations in bioprocessing and advanced manufacturing.

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Autologous cell therapies have transformed what’s possible for patients. Now it’s time to rethink the testing methods used to release them.

For many cell therapy programs, the manufacturing processes have been engineered to compress timelines where possible. Cells are collected, engineered, expanded, tested, and prepared for reinfusion on timelines where even small delays matter. But contaminant detection remains one of the areas where the field still depends heavily on growth-based methods for sterility, mycoplasma, and adventitious agent testing.

That mismatch creates a practical problem. Advanced therapies are increasingly personalized, time-sensitive, and operationally complex. Release testing needs to evolve with the products it supports.

Growth-Based Testing Was Not Built for Modern Cell Therapy Timelines

Traditional contaminant testing is effective because it is conservative, familiar, and rooted in established regulatory expectations. But it is also slow by design. Many methods depend on giving bacteria, fungi, mycoplasma, or viruses enough time to grow to detectable levels.

That time requirement creates a major bottleneck for autologous cell therapies. When the full vein-to-vein process may take about a month, waiting for safety results consumes a meaningful share of the overall timeline. The issue is not that legacy methods lack value. The issue is that cell therapy manufacturing has outpaced the speed of the testing model.

Sequencing-Based Analytics Could Create a Faster Detection Model

Sequencing-based contaminant detection offers a different model: identify microbial or viral nucleic acids directly rather than waiting for organisms to grow.

At ElevateBio, we are developing NGS-based rapid analytics for cell therapy release testing. The workflow extracts DNA or RNA from a representative cell therapy product, prepares sequencing libraries, uses hybrid capture to enrich relevant targets, and applies custom bioinformatics to identify bacterial, fungal, or viral species. In early feasibility studies, this approach detected two fungal and three bacterial contaminants at approximately 10 CFU per 75,000 cells, as well as five viral contaminants at 1–10 genome copies per 7,500 cells (see the data).

Those results do not eliminate the need for further development. They do show that sequencing-based methods detect a diverse range of potential contaminants in a cell therapy-relevant background.

The Bigger Opportunity Is One Analytical Framework for Multiple Contaminant Classes

The value of sequencing is not only speed. It is breadth.

A sequencing-based approach has the potential to consolidate detection across bacteria, fungi, and adventitious viruses within a common analytical framework. It also produces digital, species-level information that may support more informative investigations when a signal is detected.

That matters because rapid release is not simply about getting to a pass/fail answer faster. It is about creating a more responsive quality model: one that can detect risk earlier, characterize it more precisely, and support better decisions before product release.

Rapid Release Will Require Both Innovation and Validation

Sequencing-based analytics are not a shortcut around safety expectations. They must be characterized, qualified, and validated with the same rigor expected of any release-relevant method.

The next work is clear: further define limits of detection, reduce cost and turnaround time, evaluate additional technologies, and demonstrate performance across more representative product types. The long-term opportunity is equally clear. Faster contaminant detection could help cell therapy programs reduce release bottlenecks while maintaining the safety standards patients depend on.

Rapid release starts with faster, more informative contaminant detection. Sequencing-based analytics are not just a new test. They are a path toward a release model better matched to the timelines and complexity of modern cell therapy.

View the Related Poster and Video Presentation

Gary Sommerville Ph.D., Principal Scientist, NGS, Technical Services

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Gary Sommerville is a Principal Scientist in ElevateBio’s Next-Generation Sequencing core lab, where he leverages over a decade of genomics expertise as the wet lab lead to drive cross-functional collaboration supporting internal R&D initiatives. He also leads assay development and onboards external sequencing clients seeking to utilize ElevateBio’s NGS technical capabilities.

Prior to ElevateBio, Gary spent six years as a Senior Scientist at Dana-Farber Cancer Institute’s Molecular Biology Core Facilities, where he led sequencing data generation for internal stakeholders and Harvard Medical School collaborators.

Gary earned his Ph.D. in Molecular Medicine from Trinity College Dublin, Ireland, investigating molecular signatures of cancer stem cells across various cancer types with and without BRAF V600E mutations.

In his free time, Gary enjoys traveling, attending sporting events with his children, and pursuing an ever-elusive scratch handicap in golf.

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