AAV platform speeds gene therapy programs, says Charles River

Charles River Laboratories has launched its nAAVigation vector platform, which it says has the ability to reduce a gene therapy developers program timeline by 55%.

According to Charles River Laboratories (CRL), its nAAVigation platform has been designed using its adeno-associated virus (AAV) vector contract development and manufacturing organization (CDMO) experience.

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The company claims that its nAAVigation technology removes the need for significant process development by streamlining the pathway to AAV vector production. Additionally, CRL says that the 55% reduction to a program’s timeline equates to less than eight months compared to traditional manufacturing practices.

“The significant turnaround time reduction for viral vector therapy developers utilizing nAAVigation combined with Charles River’s established development process, standard, on-hand materials, templated documents, and in-house analytics will enhance our clients’ experiences,” said Daniel Smith, executive director global cell and gene therapy portfolio at CRL.

From CRO to CDMO

While traditionally a clinical research organization (CRO), CRL has increased its presence in the contract development and manufacturing organization (CDMO) over the past few years through its M&A activity.

Having acquired WIL Research in 2016, the firm added a small molecule CDMO in the form of QS Pharma. However, the firm turned its back on the CDMO space by divesting that business the following year. In February 2021, CRL reentered the CDMO sphere by acquiring Cognate Bioservices for $875 million and just three months later, the firm bolstered its CDMO capabilities with its $300 million Vigene Biosciences buy.

The company claims that its nAAVigation technology removes the need for significant process development by streamlining the pathway to AAV vector production. Additionally, CRL says that the 55% reduction to a program’s timeline equates to less than eight months compared to traditional manufacturing practices.

“The significant turnaround time reduction for viral vector therapy developers utilizing nAAVigation combined with Charles River’s established development process, standard, on-hand materials, templated documents, and in-house analytics will enhance our clients’ experiences,” said Daniel Smith, executive director global cell and gene therapy portfolio at CRL.

Cell line approach

CRL says that its nAAVigation’s approach is based on a high-productivity HEK293 suspension cell line, which is able to meet clients’ scale-up and serotype requirements. The platform itself uses an optimized single-use upstream method in conjunction with downstream purification processes. In turn, CRL states that this allows its customers AAV programs to scale-up to 500, L in suspension.

Furthermore, through the use of development processes, templated documents, on-hand materials, and in-house analytics, the platform has the potential to accelerate time to clinic.

“The launch of the nAAVigation vector platform process is the latest in a series of portfolio enhancements aimed at supporting our cell and gene therapy clients from early target identification through clinical-stage manufacturing,” Kerstin Dolph, corporate senior vice president, biologics solutions at CRL said.

“By increasing speed and efficiency for viral vector production, nAAVigation will help accomplish our ultimate goal of delivering safe, effective therapies to patients faster.”