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Quality by Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development

By: B. Cooney, et al Reprinted with the permission of BioProcess International, Quality by Design (QbD) is a modernized approach to pharmaceutical development that is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate and improve the manufacturing process within defined ranges without obtaining prior regulatory...

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Global Biomanufacturing Trends, Capacity and Technology Drivers: Industry Biomanufacturing Capacity Overview

By: P. Seymour, D. Ecker Reprinted with the permission of American Pharmaceutical Review , Biologic-based drugs are an increasingly important part of the product growth strategies for pharmaceutical and biopharmaceutical companies. As the number of commercial products and pipeline candidates grows, a crucial issue facing the industry is the current and future...

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Biopharmaceutical Manufacturing Process Validation and Quality Risk Management

By: F. Castillo, et al Reprinted with the permission of Pharmaceutical Engineering, May-June, 2016 Manufacturing processes for biopharmaceuticals must be designed to produce products that have consistent quality attributes. This entails removing impurities and contaminants that include endotoxins, viruses, cell membranes, nucleic acids, proteins, culture media components, process chemicals, and ligands leached...

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Responding to an FDA 483 form

By: T. Burtis Reprinted with the permission of BioProcess International, February 2016 BPTC Senior Consultant Taylor Burtis recommends a straight forward, five step process for managing a company’s response to the issuance of an FDA 483. Earlier in her career, she held senior-level regulatory positions in the biopharmaceutical industry as well as...

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Getting flexible with manufacturing

By: S. Haigney Reprinted with the permission of Pharmaceutical Technology, September 2015 BPTC Vice President and Principal Consultant, Tom Ransohoff, was interviewed on the latest trends in flexible manufacturing in the September 2015 issue of Pharmaceutical Technology. Additional interviewees include Olivier Loeillot, General Manager, Asia, BioProcess, GE Healthcare’s Life Sciences business and...

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High-throughput process development approaches for biopharmaceuticals

By: S. Jones, et al Reprinted with the permission of American Pharmaceutical Review, 2015 Jan-Feb Development of a robust, reproducible biopharmaceutical manufacturing process is a critical path activity in the overall early development timeline. Platform processes have enabled companies to perform process development in shorter timeframes for molecules such as antibodies. However,...

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