Pharmaceutical Technology February 2018

February 2018 | Volume 2018 Supplement, Issue 1
Pharmaceutical Technology Partnerships in Outsourcing Supplement 2018 Issue
Features
Mark Egerton, PhD, chief executive officer of Quotient Sciences, shares insights on a new approach to accelerate drug development, which integrates formulation development, real-time adaptive GMP manufacturing, and clinical research within a single platform.
Industry lessons from a fast-track technology transfer of a soft-gelatin capsule (softgel) are multifold. This case study reviews the success factors for effective execution of the technology transfer, which include: strong relationship between the customer, the contract development and manufacturing organization, and other partners based on deep knowledge in the technology; established and proven quality-by-design processes; risk mitigation management; project leadership; flawless execution; and mutual trust.
Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.
A different perspective on controlling fixed costs of biomanufacturing, based on know-how from other industries, provides a competitive edge, says the CEO of Samsung BioLogics.
Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.
CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.
Research suggests that working with a single contract partner can reduce development time and improve economics.
Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.
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