BioPharm International-05-15-2017

The authors examine the selection process of the contract manufacturing–pharmaceutical relationship and the communication challenges that pharmaceutical firms face prior to and during the CMO selection process.

Andrea Zobel, senior director of product management, clinical trial supply, and logistics at PAREXEL International, examines key issues and questions that sponsors and contract partners must address.

Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.

BioPharm International speaks with a CMO to find out how it is coping with capacity challenges, regulatory authority scrutiny, supply chain reliability, and new requests from clients to incorporate continuous manufacturing into processing lines.

Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.

The article reviews strategies for firms with or without existing in-house capacities and the pros and cons for outsourcing bio/pharmaceutical development and manufacturing.

Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.

FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.

This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.