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Catalent's (CTLT) New Launch to Enhance Gene Therapy Development

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Catalent, Inc. CTLT has recently introduced its new UpTempo Virtuoso platform process. The platform is designed for the development and CGMP (current good manufacturing practices) manufacturing of adeno-associated viral (“AAV”) vectors.  

It is worth mentioning that the suspension-based UpTempo Virtuoso platform includes optimized standard protocols for cell culture, transfection and downstream purification. It also includes a standardized bill of materials to streamline the critical supply chain and material qualification.

The latest launch is expected to help Catalent significantly strengthen its foothold in the global cell and gene therapy business, a component of the company’s broader Biologics segment.

Significance of the Launch

The UpTempo Virtuoso platform is expected to standardize and simplify various time-consuming steps in AAV manufacturing. This is likely to significantly lessen the timeline from gene to clinic and enable rapid first-in-human clinical evaluation.

The new platform has been developed to deliver a CGMP-ready enhanced process capable of yielding drug products for clinical evaluation in nine months. This will potentially reduce the conventional development pathway considerably, thereby helping manage more predictable conclusions. Apart from this, customers using this new process will have access to Catalent’s integrated supply chain of plasmid DNA (pDNA), thereby offering further possibilities to cut development timelines.  

Per management, the new process has been designed with the aim of providing Catalent’s customers with a reliable, reproducible and scalable path to clinic. Management has also confirmed that with the expansion of the gene therapy pipeline to a broader disease portfolio and in anticipation of increasing regulatory requirements, the company’s enhanced CGMP manufacturing process has been developed to meet robust regulatory submission guidelines for AAV gene therapy products while providing customers with the advantage of reduced timelines.

Industry Prospects

Per a report by Research and Markets, the global cell and gene therapy market was valued at $4.99 billion in 2021 and is anticipated to reach $36.92 billion by 2027 at a CAGR of approximately 39.6%. Factors like increasing incidences of rare and chronic diseases, advancements in cell and gene therapy, and rising number of clinical trials are likely to drive the market.

Given the market potential, the latest launch is expected to significantly strengthen Catalent’s global business.

Notable Developments in Biologics

In April, Catalent acquired Erytech Pharma’s commercial-scale cell therapy manufacturing facility in Princeton, NJ. The deal includes an exclusive long-term supply agreement for Catalent to support Erytech’s lead product candidate, eryaspase (GRASPA), which is currently in late-stage development for the treatment of acute lymphoblastic leukemia.

The same month, Catalent announced the acquisition of a biologics development and manufacturing facility currently under construction near Oxford, U.K., from Vaccine Manufacturing and Innovation Centre UK Limited. This facility addition is expected to expand Catalent’s presence in the U.K. and across Europe.

In March, Catalent announced the completion of a $30-million (€27 million) project at its facility in Limoges, France. The project completion is expected to convert the site into a European center of excellence for biopharmaceutical development, drug product fill/finish services and packaging.

Price Performance

Shares of the company has lost 5.6% in the past year compared with the industry’s 33.2% decline and the S&P 500's 6.1% fall.

Zacks Investment Research
Zacks Investment Research


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Zacks Rank & Key Picks

Currently, Catalent carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space include Omnicell, Inc. OMCL, Patterson Companies, Inc. PDCO and AMN Healthcare Services, Inc. AMN.

Omnicell, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 16%. OMCL’s earnings surpassed the Zacks Consensus Estimate in three of the trailing four quarters, the average beat being 13.4%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Omnicell has lost 20.1% compared with the industry’s 44.8% fall over the past year.

Patterson Companies has an estimated long-term growth rate of 9.9%. PDCO’s earnings surpassed estimates in three of the trailing four quarters, the average beat being 2.7%. It currently carries a Zacks Rank #2.

Patterson Companies has lost 11.1% compared with the industry’s 7.4% fall over the past year.

AMN Healthcare has an estimated long-term growth rate of 1.1%. AMN’s earnings surpassed estimates in the trailing four quarters, the average beat being 15.6%. It currently sports a Zacks Rank #1.

AMN Healthcare has lost 1.1% compared with the industry’s 63.4% fall over the past year.


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