BioPharm International-07-01-2019

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Using a QbD approach from early-stage development through commercialization can ensure that upstream processes are efficient and reliable.

FDA and USP take sides in debate on biologic drug standards.

Real-time monitoring of product- and process-related impurities remains a challenge.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

Although downstream efficiency still lags behind upstream, engineering-driven innovation is breaking through boundaries.

The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.

In this study, a novel aldo-keto reductase was cloned and purified, and its important conserved sites were analyzed.

Recently released equipment and products include microbioreactor systems, cell therapy automation software, and IIoT-enabled flow sensors.

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