Charles River (CRL) Launches LVV-based Gene Therapy Platform

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Charles River Laboratories International, Inc. CRL recently launched its lentiviral vector (LVV) manufacturing platform, Lentivation.  The technology can reduce LVV manufacturing timelines for gene and gene-modified cell therapies by up to 60%, equating to less than seven months compared with typical manufacturing workflows.

Lentivation leverages Charles River's robust screening toolbox for tackling challenging gene-of-interest plasmids, off-the-shelf (OTS) LVV packaging plasmids, phase-appropriate production with fit-for-purpose facilities, on-hand materials and in-house analytics to meet growing client needs for clinical and commercial supply.

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Charles River offers standardized protocols for cell culture, transfection, and downstream purification thanks to its over 20 years of experience as a viral vector contract development and manufacturing organization (CDMO) and validated platform processes with a successful track record.

The addition of Lentivation comes on the heels of the release of Charles River's OTS LVV packaging and AAV helper plasmids, as well as the eXpDNATM plasmid manufacturing platform, all of which are aimed at enabling both LVV-based and AAV-based gene therapy programs. Lentivation complements the previously disclosed nAAVigationTM platform, substantially strengthening Charles River's cell and gene therapy manufacturing capabilities.

These offers result from decades of plasmid DNA and viral vector CDMO scale-up experience, which drastically decreases production turnaround time for ATMP and vaccine developers when paired with the company's in-house testing capabilities.

Significance of New Launch

Per management, the company is excited to expand its strong range of current capabilities by integrating the Lentivation platform. The LVV production options allow CRL to support more sophisticated therapy programs and, most importantly, provide patients worldwide with cutting-edge gene therapies.

The LVV platform from Charles River offers medicinal developers an efficient, dependable route to the clinic and the market. The proven platform expands on Charles River's well-established capabilities and procedures, refined over decades of effectively supporting advanced therapy clients.

Industry Prospects

Per a report by Grand View Research, the global gene therapy market was valued at $7.54 billion in 2022 and is expected to grow at a CAGR of 19.1% by 2030.  The market's growth is attributed to factors such as expanding the area of advanced therapies along with gene delivery technologies and developing progressive competition among key players focused on commercializing their therapies.

Developments Within Peers

Companies like Illumina, Inc. ILMN, QIAGEN N.V. QGEN and PacBio PACB are also progressing in Cell and Gene therapy.

In August 2023, PacBio — a developer of high-quality, highly accurate sequencing solutions and GeneDx and a leader in delivering improved health outcomes through genomic and clinical — entered into a research collaboration with the University of Washington to study the capabilities of HiFi long-read whole genome sequencing (WGS) to increase diagnostic rates in pediatric patients with genetic conditions.

In July 2023, Illumina launched the latest version of DRAGEN software, DRAGEN 4.2, to analyze next-generation sequencing (NGS) data. DRAGEN 4.2 is expected to expand accuracy, flexibility and scalability to enable efficient workflows and extract meaningful insights from genomic data. Per an expert familiar with DRAGEN software, the latest offering of DRAGEN 4.2 is likely to be a significant step for genomics analysis as it combines the detection of multiple variant types in addition to a single nucleotide variant or SNV.

The same month, QIAGEN expanded its digital PCR (dPCR) offering for the biopharma sector's cell and gene therapy development in partnership with Niba Labs. With their combined offerings, QIAGEN and Niba Labs can assist companies in developing cell and gene therapies to overcome significant resource limitations and adhere to stringent project deadlines. The partnership will offer the biopharma sector the most cutting-edge analytical options to satisfy the sector's changing needs and enhance its cell and gene therapy products.

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