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Charles River (CRL) Introduces Novel IgY-Based ELISA Kit

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Charles River Laboratories International, Inc. (CRL - Free Report) recently introduced its first Enzyme-Linked Immunosorbent Assay (ELISA) Kit for the detection and quantitation of remaining host cell proteins (HCP) in CHO-based biotherapeutics. The HCP-ELISA is built upon Company’s HCP-GAPex service, enhancing the efficiency and efficacy of HCP assay development.

The recent launch of the ELISA kit bolsters Charles River’s robust Biologics Testing offering.

About IgY-Based ELISA Kit

Charles River’s new HCP-ELISA kit utilizes avian IgY antibodies as the primary detection technology. These antibodies are derived from Specific-Pathogen-Free Chicken (SPF) Eggs and developed entirely by AVS Bio.

HCP-ELISA kit can be bought individually and run by the client at their facility. Clients are also offered the opportunity to have Charles River’s industry experts perform the assay, delivering a wide range of supporting services.

Charles River’s HCP-GAPex program offers a streamlined transition from off-the-shelf generic ELISA kits to a fully validated product-specific assay, customized for each product once the drug candidate has progressed into late-phase clinical trials.

Benefits of IgY-Based ELISA Kit

Per management, using ideal tools for impurity control is crucial for a quality-by-design approach in drug development. The superior specificity and coverage of the new kit lower the risk of undetected host cell proteins during early process optimization. This leads to a faster and smoother transition from early to late phase and registration.

AVS Bio is the producer of Specific-Pathogen-Free Chicken (SPF) eggs in the United States and has been dedicated to offering high-quality antibodies for research and development for many years. This collaboration with Charles River highlights the versatility and effectiveness of the IgY in the field of biotherapeutics.

Industry Prospects

Per a report by Grand View Research, the global biological safety testing products & services market size was valued at $2.77 billion in 2018 and is expected to grow at a CAGR of 12.3%. The increasing production of new-generation biologics by major pharmaceutical and biotechnology companies and the high prevalence of target diseases globally are driving the market.

Recent Developments

In January 2023, Charles River announced a viral vector contract development and manufacturing organization (CDMO) partnership with Rznomics Inc. The South Korea-based biopharmaceutical company, Rznomics, will leverage Charles River’s viral vector CDMO experience to initiate clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

Zacks Investment ResearchImage Source: Zacks Investment Research

In the same month, Charles River announced viral vector contract development and manufacturing organization (“CDMO”) partnership with Rznomics. Charles River’s viral vector CDMO experience will be utilized by Rznomics to begin clinical development of its RNA-based anticancer gene therapy in liver cancer patients.

Price Performance

Shares of the company have gained 10.4% in the past six months against the industry’s fall of 2.8%.

Zacks Rank and Key Picks

Currently, Charles River carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , Cardinal Health, Inc. (CAH - Free Report) and Merit Medical Systems, Inc. (MMSI - Free Report) .

AMN Healthcare, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 3.3%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 10.9%.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

AMN Healthcare has gained 5.4% against the industry’s 19.6% decline in the past year.

Cardinal Health, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 11.6%. CAH’s earnings surpassed estimates in two of the trailing four quarters and missed the same in the other two, the average beat being 6.4%.

Cardinal Health has gained 48.7% against the industry’s 0.8% decline over the past year.

Merit Medical, flaunting a Zacks Rank #2 at present, has an estimated long-term growth rate of 11%. MMSI’s earnings surpassed estimates in all the trailing four quarters, the average beat being 25.4%.

Merit Medical has gained 28.1% against the industry’s 0.8% decline over the past year.

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