Author Archives: Jeffrey Staecker

Methods on the Move: Addressing Method Transfer Challenges for the Biopharmaceutical Industry

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Analytical method transfers are essential components of the current global biotechnology environment. Analytical method transfer can be defined as “a documented process that qualifies a laboratory (the receiving laboratory) to use a validated analytical test procedure that originated in another laboratory (sending laboratory), thus ensuring that the receiving laboratory has the procedural knowledge and ability to perform the transferred analytical procedure as intended†(1). The goal is to ensure that a method continues to perform in the validated state regardless…

June 20, 2018

Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry

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Expanding biopharmaceutical pipelines and therapeutic modalities are feeding a boom in outsourcing key elements of development and manufacturing projects. The rapid growth of the industry as well as of emerging therapeutic areas (e.g., antibody–drug conjugates, biosimilars) challenge sponsors and contractors alike to meet industry needs. The authors in this featured report explore increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on…

March 9, 2017

CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities, An Overview

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Introduction by Cheryl Scott The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing technologies in a regulated environment…

April 12, 2016

Effective Management of Contract Organizations: Keeping the Product Pipeline Moving, Compliant, and Available

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Both small and large biopharmaceutical companies are increasingly pursuing the outsourcing of manufacturing and testing throughout the product lifecycle. The growing use of contract manufacturing organizations (CMOs) and contract testing organizations (CTOs) has led to increasing complexity within the biopharmaceutical industry as more third-party sites are leveraged to support global markets. To address those issues, a CASSS Chemistry, Manufacturing, and Controls (CMC) Strategy Forum was held in Washington, DC, 27–28 July 2014. The title was “Effective Management of Contract Organizations: Sponsors, Contract Organizations, Health Authorities and Patients — Keeping the Product Pipeline Moving, Compliant, and Available.†The CMC Strategy Forum is…

October 15, 2015