10.03.18 -- CMC Hiring And Practice: 6 Lessons For Outsourcing
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By Louis Garguilo, Chief Editor, Outsourced Pharma
Things have progressed nicely for Ruby Casareno, Vice President, Chemistry, Manufacturing and Controls (CMC), Allakos Inc. For executives wishing the same for your CMC leadership and organization, there are lessons on why that’s the case. Those lessons also recall for Casareno an earlier experience where progression traversed a rockier road. It all adds up to 6 best practices particular to outsourcing drug development and manufacturing.
By Bernhard J. Paul, Ph.D., principal consultant, Carinth Consulting LLC
Virtually every biotech or pharmaceutical company relies on CDMOs for R&D and manufacturing services or to access specialized technology to bring their drug candidates to the market. Identifying and selecting CDMOs is a lengthy and difficult process, and it is critically important to select the right partner. This is the second article in a five-part series exploring questions that will help you during the selection process and enable you to choose the right partner for your project.
By Sue Schniepp, Regulatory Compliance Associates Inc.
Quality metrics, quality culture, and data integrity are among the current and emerging topics of interest to the pharmaceutical industry of particular concern to both the industry and regulatory authorities. To understand how these three topics relate to each other it is important to understand some of the history that led up to today’s environment, where quality metrics, quality culture, and data integrity come together to establish current global regulatory expectations.