Customer Relationship Management in Contract Manufacturing
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.
Preparing an Approach to Cold Chain for Cell- and Tissue-Based Therapies
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.
Getting Biopharmaceutical Tech Transfer Right the First Time
Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
CMOs Tackle New Challenges
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.
Gearing Up for Biosimilars
Contract manufacturers prepare for anticipated biosimilars manufacturing demands through expansion and acquisition.
Insourcing vs Outsourcing: Choosing the Right Strategy
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.
Operations and Quality Oversight of CMOs
Effective communication between contract manufacturing organizations and pharmaceutical company clients relies on well-defined master service and quality agreements.
Quality Metrics and CMO Agreement
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
Key Considerations in Outsourced “On-Site” Audits as Part of Supplier Qualification
This article reviews experiences with the outcome of in-house audits, audits by third parties, and purchased audit reports.
