Outsourcing

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Articles

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Contractors Balance Increased Demand During COVID-19

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

Sartorius Stedim Biotech Launches Consultancy Services for Viral Clearance Validation

Ronald A. Rader is senior director, Technical Research, at BioPlan Associates.

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

This article highlights 15 years of changes in biopharmaceutical manufacturing.

Fifteen Years of Progress: Biopharmaceutical Industry Survey Results

Hope Mueller is vice-president of continuous improvement at HorizonPharma Inc.

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

Operations and Quality Oversight of CMOs

Jana Spes is Vice-President, Technical Operations, Apotex, jspes@apotex.com.

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

Quality Metrics and CMO Agreement

David Deere is the chief commercialization officer for PaizaBio, a US-based contract manufacturing organization and consulting group with in-country aseptic fill-and-finish operations in Hangzhou, China. Deere is a veteran global pharmaceutical executive whose career path includes Valeant Pharmaceuticals International, F. Hoffman-La Roche and Genentech.

New drug approval policies promote industry growth and injectable contract manufacturing opportunities in China.

Regulatory Reform in China: Implications for Global Biopharmaceutical Companies

Biopharmaceutical manufacturers continue to put quality at the forefront of their relationships.

Biomanufacturers Demand Higher Quality Standards in 2016

Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.

Integrating Technology Transfer and Facilities Startup for Biologics

Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.

While stakeholders generally welcome improvements to quality initiatives, they are concerned with how the new requirements will be implemented for more complicated supply-chain models.

Overwhelming Response from Industry on FDA’s Guidance on Quality Metrics

David K. Haggard is an independent consultant working for Tunnell Consulting

Penny Hylton, PhD, is Managing Consultant, Tunnell Consulting

A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.

Contract Services, Regulatory Consulting