CDMO AmplifyBio Shuts Down Amid Challenging Cell and Gene Therapy Market

AmplifyBio, an Ohio-based contract development and manufacturing organization (CDMO) focused on cell and gene therapies, has announced its closure due to market challenges and financial constraints. The company's decision highlights the growing difficulties faced by early-stage developers in the advanced therapeutics sector.

Market Downturn Forces AmplifyBio's Closure

Founded in May 2021 with $200 million in funding from Battelle and other investors, AmplifyBio initially aimed to capitalize on the promising cell and gene therapy market. However, the company cited a "significant shift" in market conditions, leading to scarce investor financing for early-stage biotechs and hampering its growth trajectory.

Despite efforts to explore "all investment and acquisition opportunities," AmplifyBio's leadership, investors, and stakeholders were unable to secure a path forward for the company. The closure comes on the heels of recent cost-cutting measures, including the shutdown of its South San Francisco R&D facility acquired from PACT Pharma in 2022.

Industry-wide Challenges for Advanced Therapeutics

AmplifyBio's demise reflects broader concerns within the cell and gene therapy sector. While these advanced therapeutics offer potential one-time treatments for severely ill patients, the industry has faced setbacks related to manufacturing complexities, accessibility issues, high costs, and safety concerns.

The recent departure of Peter Marks, Ph.D., the FDA's longtime director of the Center for Biologics Evaluation and Research (CBER), has further exacerbated worries within the field. Marks was considered a key ally to advanced therapeutics developers, and his exit may present additional challenges for companies navigating the regulatory landscape.

Impact on AmplifyBio's Operations and Workforce

Prior to its closure, AmplifyBio had expanded its operations and workforce significantly. In February 2023, the company reported a workforce of over 300 employees and had added 28 new clients in the previous year. The company's footprint included its original site at Battelle's campus in West Jefferson, Ohio, and the recently opened AmplifyBio Manufacturing Enablement Center (AMEC) in New Albany, Ohio.

AmplifyBio's services encompassed preclinical contract research for cell and gene therapies, as well as manufacturing capabilities for mRNA and plasmid products. The company's closure is likely to impact ongoing projects and collaborations within the industry, potentially creating ripple effects for partner organizations and clients.

As the cell and gene therapy landscape continues to evolve, AmplifyBio's fate serves as a cautionary tale for other early-stage companies and investors in this high-risk, high-reward sector. The industry now faces the challenge of balancing innovation with financial sustainability in an increasingly competitive and scrutinized market.