The traditional approach to biopharma outsourcing—where a sponsor hands a defined process to a contract manufacturer for execution—is no longer sufficient for many complex cell and gene therapies, says David Enloe, CEO of Rose BioSolutions. He argues that contract development and manufacturing organizations (CDMOs) should operate more like extensions of their clients’ teams.
Manufacturing capacity remains important, but Enloe says programs increasingly depend on scientific leadership, regulatory and quality expertise, and effective project management. For technically demanding therapies, sponsors and CDMOs need to assess risks together, question assumptions, and consider the full development path rather than simply follow a transferred procedure.
Rose is investing in specialist support at the start of client programs, when manufacturing or regulatory risks may be easier to address. Early collaboration can help prevent process changes from leading to substantial rework, Enloe says. It also reflects a growing emphasis on ensuring that new therapies can be manufactured reliably, reproducibly, and at scale.
The company’s approach includes giving clients direct access to technical leaders and encouraging open communication. Enloe says greater transparency about objectives and constraints helps both sides stay accountable for decisions and timelines, and tackle problems before they threaten a program.
Enloe spent about 15 years working on the sponsor side before moving into CDMO leadership. He says that experience helps him understand the pressures developers face. He views manufacturing as part of the route from a therapeutic idea to patients, rather than as a standalone operational service, and says close collaboration can help sponsors and CDMOs navigate that route together.