Charles River Laboratories Partners with Arovella Therapeutics to Advance GMP Next-Generation Sequencing for CAR-iNKT Cell Therapy Development
Charles River Laboratories International, Inc. has announced a strategic collaboration with Arovella Therapeutics Ltd. to provide Good Manufacturing Practice (GMP)-compliant Next Generation Sequencing (NGS) services that will support the development of Arovella’s innovative cell therapy platform for the treatment of blood cancers. The partnership represents another important step toward accelerating the development of advanced cell and gene therapies by combining cutting-edge genomic technologies with comprehensive quality testing and regulatory expertise.
The collaboration will support Arovella’s lead investigational therapy, ALA-101, an off-the-shelf chimeric antigen receptor invariant natural killer T (CAR-iNKT) cell therapy being developed for patients with CD19-positive B-cell lymphomas and leukemias. Through the agreement, Charles River will perform GMP-grade NGS testing for cell bank characterization while also providing viral safety release testing for clinical manufacturing batches.
The announcement also highlights an important regulatory achievement. The U.S. Food and Drug Administration (FDA) recently accepted the use of Next Generation Sequencing as part of Arovella’s Investigational New Drug (IND) application for viral safety testing of two cell banks used in the ALA-101 manufacturing process. This acceptance reflects the growing confidence among regulators in advanced sequencing technologies as reliable tools for ensuring the safety and quality of cell therapy products.
Strengthening Manufacturing Quality for Advanced Cell Therapies
Cell and gene therapies require rigorous manufacturing controls because they are produced from living cells rather than traditional chemical compounds. Every stage of production—from creating master cell banks to manufacturing clinical doses—must be carefully evaluated to ensure product identity, purity, potency, and safety.
The partnership allows Arovella to leverage Charles River’s extensive experience in biologics testing and GMP manufacturing support to establish a highly robust quality control program for ALA-101.
Charles River will utilize Next Generation Sequencing to comprehensively characterize the cell banks that generate key reagents used during manufacturing. These analyses are designed to identify potential viral contaminants and verify that the cell lines meet stringent regulatory quality standards before being used in clinical production.
In addition to characterization testing, Charles River will also conduct viral safety release testing on manufactured clinical batches of ALA-101. These release tests help confirm that each batch satisfies established safety requirements before being administered to patients participating in clinical trials.
FDA Acceptance Highlights Growing Role of Next Generation Sequencing
One of the most significant aspects of the collaboration is the FDA’s acceptance of NGS-based viral safety testing within Arovella’s IND submission.
Historically, viral safety evaluations relied primarily on conventional in vitro and in vivo testing methods that often require lengthy testing timelines and may have limitations in detecting unknown pathogens.
Next Generation Sequencing offers a modern alternative capable of rapidly screening biological materials for a broad spectrum of viral agents through comprehensive genomic analysis. Rather than searching only for predetermined viruses, NGS enables unbiased detection of both known and previously unidentified microorganisms.
The FDA’s willingness to accept this technology within Arovella’s IND reflects increasing regulatory recognition that advanced sequencing methods can improve both sensitivity and efficiency while maintaining high safety standards for patients.
As more developers incorporate NGS into manufacturing workflows, the technology may help shorten development timelines while supporting increasingly sophisticated cell and gene therapy programs.
Charles River Expands Support for Advanced Therapeutics
Charles River Laboratories continues to broaden its capabilities to meet the growing demands of the advanced therapeutics industry.
Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River Laboratories, emphasized that supporting Arovella’s innovative iNKT platform aligns closely with the company’s strategy of delivering comprehensive development and manufacturing services to biotechnology clients.
She noted that the FDA’s acceptance of NGS within Arovella’s IND submission demonstrates the growing importance of GMP-ready sequencing technologies in supporting safer and more efficient development of complex biologic medicines.
According to Dolph, Charles River remains committed to providing scientific expertise and integrated testing solutions that enable clients to move promising therapies through clinical development while maintaining rigorous quality standards.
The collaboration also reflects Charles River’s broader investment in next-generation analytical technologies designed specifically for emerging modalities such as gene editing, cell therapies, viral vectors, and regenerative medicine.
Arovella Advances Off-the-Shelf CAR-iNKT Therapy
Arovella Therapeutics is developing ALA-101 as an allogeneic—or “off-the-shelf”—CAR-iNKT therapy targeting CD19-positive hematologic malignancies.
Unlike conventional CAR-T therapies, which require cells to be collected individually from each patient before manufacturing, ALA-101 is designed to be produced in advance from donor-derived invariant natural killer T cells. This approach has the potential to simplify manufacturing, reduce treatment delays, and improve patient access.
Invariant natural killer T cells possess characteristics of both innate and adaptive immune systems, allowing them to recognize and eliminate cancer cells while potentially reducing some of the safety concerns associated with traditional CAR-T therapies.
By combining CAR technology with iNKT cells, Arovella aims to create a readily available immunotherapy capable of treating patients with B-cell lymphomas and leukemias without the lengthy production timelines required for personalized therapies.
The manufacturing process for such advanced therapies requires exceptionally high standards of quality control, making comprehensive characterization and viral safety testing essential components of development.
Commitment to Safety and Regulatory Excellence
Dr. Nicole van der Weerden, Chief Executive Officer of Arovella Therapeutics, described the collaboration as an important milestone in strengthening the company’s clinical manufacturing program.
She explained that integrating advanced Next Generation Sequencing for comprehensive cell bank characterization, alongside validated viral safety testing for clinical batch release, reinforces Arovella’s commitment to maintaining the highest standards of safety, product quality, and regulatory compliance.
According to van der Weerden, these advanced analytical approaches help ensure that patients receive therapies manufactured under robust scientific and quality systems while supporting efficient regulatory review throughout clinical development.
The partnership also provides access to Charles River’s extensive expertise in biologics testing, allowing Arovella to benefit from established quality systems that have supported numerous therapeutic development programs worldwide.
Next Generation Sequencing Is Transforming Biopharmaceutical Testing
NGS has become one of the fastest-growing technologies in pharmaceutical quality control because of its ability to generate comprehensive genetic information quickly and accurately.
Compared with conventional testing approaches, sequencing technologies offer several important advantages:
- Comprehensive detection of viral contaminants and microbial agents
- High-throughput analysis capable of evaluating large genomic datasets
- Greater sensitivity for identifying low-level contaminants
- Faster turnaround times for complex biological testing
- Improved scalability for commercial manufacturing
These advantages make NGS particularly valuable for advanced therapeutics, where manufacturing materials often involve living cells, viral vectors, engineered tissues, or genetically modified organisms.
Charles River’s GMP-compliant NGS services are designed to satisfy global regulatory expectations, including requirements established by the FDA, European Medicines Agency (EMA), and International Council for Harmonisation (ICH) guidelines governing biological product safety.
Expanded Capabilities Following Pathoquest Acquisition
Charles River has further strengthened its sequencing expertise through its recent acquisition of Pathoquest, a company specializing in Next Generation Sequencing solutions for biopharmaceutical characterization and quality control.
The acquisition significantly expands Charles River’s capabilities in sequencing-based pathogen detection, cell bank characterization, and quality testing for advanced therapeutic products.
By integrating Pathoquest’s specialized expertise into its existing biologics testing network, Charles River can now provide faster, more comprehensive NGS services throughout the drug development lifecycle, from early research through commercial manufacturing.
This expanded infrastructure positions the company to support the rapidly growing global market for cell and gene therapies, where demand for advanced analytical testing continues to increase.
Comprehensive Biologics Testing Infrastructure
Beyond sequencing services, Charles River offers a broad portfolio of biologics testing and manufacturing support designed to assist developers throughout every stage of product development.
Its capabilities include GMP-compliant cell banking, cell line characterization, viral safety testing, storage services, and regulatory support.
The company operates multiple GMP-compliant cleanroom facilities and maintains extensive infrastructure capable of producing and storing thousands of cell and viral banks for biotechnology and pharmaceutical clients worldwide.
These integrated services allow developers such as Arovella to streamline manufacturing workflows while maintaining consistent product quality and regulatory compliance as therapies progress from laboratory research into clinical development and, ultimately, commercial production.
Supporting the Future of Cell and Gene Therapy
The collaboration between Charles River Laboratories and Arovella Therapeutics reflects broader trends across the biotechnology industry, where advanced manufacturing technologies, genomic analytics, and regulatory innovation are becoming increasingly interconnected.
As novel therapies such as CAR-iNKT cells continue to advance, sophisticated analytical tools like Next Generation Sequencing are expected to play an increasingly important role in ensuring product quality, patient safety, and regulatory confidence.
By combining Charles River’s GMP testing expertise with Arovella’s innovative immunotherapy platform, the collaboration aims to establish a strong manufacturing and quality foundation for ALA-101 while supporting continued progress toward new treatment options for patients living with lymphoma, leukemia, and other serious cancers.
About Arovella Therapeutics
Arovella Therapeutics Ltd (ASX: ALA) is a biotechnology company focused on developing its invariant natural killer T (iNKT) cell therapy platform from Imperial College London to treat blood cancers and solid tumours. Arovella’s lead product is ALA-101. ALA-101 consists of CAR19-iNKT cells that have been modified to produce a Chimeric Antigen Receptor (CAR) that targets CD19. CD19 is an antigen found on the surface of numerous cancer types.
iNKT cells also contain an invariant T cell receptor (iTCR) that targets glycolipid bound CD1d, another antigen found on the surface of several cancer types. ALA-101 has had its IND accepted by the US FDA and is being developed as an allogeneic cell therapy, which means it can be given from a healthy donor to a patient. Arovella is also expanding into solid tumour treatment through its CLDN18.2-targeting technology licensed from Sparx Group. Arovella will also incorporate its IL-12-TM technology into its solid tumour programs.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.