Charles River Laboratories International, Inc. CRL recently launched Helper Plasmid. This is designed to secure supply and streamline adeno-associated virus (AAV)-based gene therapy programs from early discovery through commercial manufacturing. The device is currently available in Research Grade (RG), High Quality (HQ), and Good Manufacturing Practice (GMP)-grades.
This off-the-shelf pHelper offering adds to the company’s comprehensive collection of contract development and manufacturing organization (CDMO) products and services.
About Helper Plasmids
The pHelper plasmids are the first in the company’s off-the-shelf plasmid product portfolio which is aimed at supporting AAV-based gene therapy programs. It is developed to simplify complex supply chains and safeguard viral vector packaging in cell and gene therapy programs.
The manufacturing process of the same is authenticated with Chemistry, Manufacturing and Controls information and a Certificate of Analysis to support regulatory filings and approval applications.
Per management at Charles River, the company remains committed to supporting advanced therapy developers with a rapid supply of critical plasmid DNA starting materials to expedite their programs. The combination of Charles River’s established plasmid and viral vector CDMO capabilities and the newest in-stock packaging plasmids for RG, HQ, and GMP grade plasmids, will help to accelerate timelines and ensure the highest quality product with one partner.
The use of standard off-the-shelf plasmids such as pHelper AAV-based gene therapy developers can potentially speed up the production timelines and help in the reduction of program development costs. The product delivers reliability and is readily available to be used. The company cites that the manufacturing process is free of any animal component, without compromising on quality.
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The plasmid has been previously used in AAV production for a range of serotypes, therapeutic trans-genes, and scales. While offering Kanamycin antibiotic resistance, the product can be accessed without any license and royalty fees throughout the research to the commercial phase.
More on the News
In recent years, Charles River has significantly broadened its cell and gene therapy portfolio with several acquisitions and recent expansions. This comes with the intention to simplify complex supply chains and meet the growing global demand for plasmid DNA, viral vector, and cell therapy services.
Simultaneously, the company also provides end-to-end support and supply chain simplification for cell and gene therapy developers. Combined with the company’s legacy testing services, Charles River offers an industry-leading “concept-to-cure” solution for advanced therapies.
The addition of pHelper plasmids follows the launch of the eXpDNA plasmid manufacturing platform, which is built upon decades of plasmid DNA CDMO scale-up experience. The universal, standardized platform significantly reduces plasmid production turnaround time for advanced therapy medical products and vaccine developers.
Per a Research report, the global plasmic DNA manufacturing market size was valued at $1.29 billion in 2022 and is expected to witness a compound annual growth rate of 17.63% by 2030.
The increasing awareness about cell and gene therapy boosts industry growth. This is mainly due to a rise in cell and gene therapy products, which are used in the treatment of various diseases globally and the availability of approved gene therapy products.
In March 2023, Charles River launched a cloud-based platform Apollo. This industry-leading platform offers drug developers secure access to study data, milestones, documents, cost estimates, and program planning tools to save time and enhance the client experience. The platform’s current capabilities are designed to support clients with safety assessment and toxicology studies.
In the past month, the company announced a multi-program agreement with Pioneering Medicines, which is a strategic initiative within Flagship Pioneering. Through the agreement, Pioneering Medicines will have access to Logica, an artificial intelligence (AI)-powered drug solution that translates biological insights into optimized preclinical assets by leveraging Valo Health’s AI-powered Opal Computational Platform and Charles River’s leading preclinical expertise.
In the past six months, shares of the company have declined 0.1% compared to the industry’s fall of 8.7%.
Zacks Rank and Key Picks
Charles River carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the overall healthcare sector are Haemonetics Corporation HAE, TerrAscend Corp. TRSSF and Akerna Corp. KERN. Haemonetics and TerrAscend sport a Zacks Rank #1 (Strong Buy), while Akerna carries a Zack Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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