BioPharm International
May 15, 2017
Features
2017 eBook
1
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.
May 15, 2017
Features
2017 eBook
1
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.
May 15, 2017
Features
2017 eBook
1
Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
May 15, 2017
Features
2017 eBook
1
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.
May 15, 2017
Features
2017 eBook
1
Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.
May 15, 2017
Features
2017 eBook
1
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.
May 15, 2017
Features
2017 eBook
1
Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.
May 15, 2017
Features
2017 eBook
1
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
May 15, 2017
Features
2017 eBook
1
This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.