By Dave DiProspero, CRB
Interest in continuous manufacturing—as an alternative and/or addition to traditional batch manufacturing—is significant. The FDA approved Janssen Pharmaceutical's transfer from batch to continuous manufacturing for Prezista, a drug product that treats HIV. The Agency also approved Orkambi, Vertex's cystic fibrosis drug, which the company will manufacture via continuous processing. Therefore, the stage is set for additional continuous-process approvals of more prescription products in tablet form that typically have been manufactured via the batch process.