The Center for Breakthrough Medicines (CBM) has opened their new analytical testing services laboratories to address growing capacity needs in the supply-constrained cell and gene therapy market.

More than 2,500 submissions are currently under review in the FDA’s cell and gene therapy pipeline. This volume, combined with FDA’s increased scrutiny, has caused bottlenecks for product release results, with testing queues of up to 8 months. By 2025, the FDA expects to receive upwards of 200 investigational new drug (IND) applications for cell and gene therapies annually, with an estimated approval of 10 to 20 cell and gene therapies each year. This unprecedented growth comes with challenges, particularly in testing. Tremendous backlogs in critical long-lead assays across the industry are leading to 6–12-week delays for cell-based methods, safety assays, and advanced analytics.

“CBM’s testing and analytical services business has a concentrated focus on meeting the unprecedented market demand where testing queues are at all-time highs,” said Joerg Ahlgrimm, president and CEO, CBM. “Clients and patients need in-process and product release testing, and CBM can meet this need. We provide speed to market by expediting the path to approval by utilizing advanced analytical methods and platform assays to demonstrate potency, purity, identity, and safety for FDA approval.”

CBM’s testing and analytical services provides an integrated and comprehensive portfolio of services to its clients all on one campus located in the heart of Philadelphia’s Cellicon Valley, with a goal to shorten development timelines, reduce regulatory risks and accelerate cures for patients. CBM’s testing services will support custom assay development, characterization, and release for cell and gene therapy products, as well as for biologics, vaccines and plasmids. Regardless of a company’s development stage, CBM offers tailored solutions from IND through commercialization and lot release.

Dana Cipriano, senior vice president of testing and analytical services, CBM, said, “Our laboratories support R&D and GMP testing services, enabling the continued expansion of the on-site capabilities that can be scaled up at our expansive King of Prussia facility. Our testing service is backed by strong scientific expertise and advanced analytical equipment and is located across the hall from our process development and manufacturing operations, allowing us to offer a complete on-site end to end service for our manufacturing clients as well as the option for standalone external testing for our clients.

CBM’s Testing Capabilities and Expansion Plan

CBM’s testing and analytical services business occupies approximately 200,000 square feet across four buildings along with a stand-alone safety testing laboratory segregated from GMP operations on one campus. In addition to analytical development capabilities, the campus has advanced analytics at the forefront of the operation, including the following components:

• A bioassay lab that supports potency assay development with a “partner-in-plant” philosophy welcoming CBM’s clients to promote early development of these methods and provide a progressive approach to development throughout a product’s life cycle.

• An analytical lab to support assay development, full product and process characterization, as well as release testing.

• Next-generation sequencing (NGS) and molecular biology laboratories for full product characterization early in product development through commercial approval.

• Validated testing platforms to support gene therapies, cell therapies, biologics, vaccines and plasmids.

• Stability labs to support International Council for Harmonization (ICH) Q2 Stability programs.

CBM’s testing and analytical services strengthen the company as a contract testing business, making testing a key strategic asset supporting the contract development and manufacturing organization (CDMO), and helps fill an extensive and growing analytical testing shortage in the CGT industry.

“We are aggressively attacking the testing market through our massive execution and delivery of the most comprehensive analytical testing capability in the CGT industry located on one campus,” said Audrey Greenberg, co-founder and chief business officer, CBM. “Our integrated manufacturing and testing services provide quality and speed—robust and unique advantages for our clients.”