Pharmaceutical Technology-02-01-2018

Pharmaceutical Technology

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology

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.

Pharmaceutical Technology

Successful outsourcing relationships in early phase drug-development analytics are driven by partnership.

Pharmaceutical Technology
Features

February 01, 2018

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.

Pharmaceutical Technology

This article describes how to improve the regulatory journey from classification to market clearance for sponsors of medical device combination products.

Pharmaceutical Technology
Features

February 01, 2018

Research suggests that working with a single contract partner can reduce development time and improve economics.

Features
Pharmaceutical Technology

February 01, 2018

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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Pharmaceutical Technology

February 01, 2018

Click the title above to open the Pharmaceutical Technology 2018 Partnerships in Outsourcing Supplement in an interactive PDF format.