With just a handful of cell and gene therapies currently on the market, we’ve only seen the tip of the iceberg.
That’s how Cryoport’s Executive Director of Business Development, Ryan Carpentier, explains the impending industry boom in Contract Pharma. The FDA has hired 50 new clinical reviewers to handle the expected influx of NDAs, estimating it will receive more than 200 regenerative INDs per year by 2020 and approve 10 to 20 cell and gene therapies each year by 2025. Many key industry players, such as Kite and bluebird bio, are planning to open large manufacturing facilities to accommodate production and demand.
With this trend comes an overwhelming concern, Carpentier reports: pharmaceutical executives and federal officials alike are sounding the alarm about the need for established manufacturing regulations for cell and gene therapy development and distribution.
Cryoport developed Chain of Compliance™ so that both we and our clients can provide end-to-end traceability for the development and distribution of these sensitive new therapies. Although the FDA has not established specific regulations for cell and gene therapies yet, we are combining domestic and international requirements for both pharmaceutical and manufacturing processes to ensure our company and our clients are fully prepared to comply with expected federal standards.
Companies that are not prepared for such regulations will find themselves at a huge disadvantage, likely needing months or years to establish processes and reporting that comply with new regulations.