BioPharm International’s July Issue: Catching Up Downstream; A Biologics Partisan Divide

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July 2019
Volume 32, No. 7

| COVER STORY |

Catching Up Downstream

Agnes Shanley

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

Applying QbD to Upstream Processing

Susan Haigney

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

Design Considerations for a Commercial Cell and Gene Therapy Facility

Feliza Mirasol

The commercialization of cell and gene therapies prompts deeper considerations of logistics, technology, and design for manufacturing facilities.
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BioPharm International July Issue

Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
Click here to access the site ››

| RESIDUAL IMPURITIES |

Analysis of Residual Impurities in Continuous Manufacturing

Cynthia A. Challener

Real-time monitoring of product- and process-related impurities remains a challenge.
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The Bioprocessing Summit
convenes more than 1,500 international bioprocess professionals to share practical solutions for today's bioprocess challenges. Now in its eleventh year, the event has grown to include 16 distinct meetings with weeklong programming on upstream and downstream processing, analytical development and quality, formulation and stability, cell and gene therapy production, and manufacturing. Along with conferences, the Summit also includes short courses and training seminars that provide in-depth coverage of critical bioprocess topics.
Learn more at BioprocessingSummit.com ››

| PEER-REVIEWED |

Catalytic Site Analysis and Characterization of a Solvent-Tolerant Aldo-Keto Reductase

Wei Jiang, Rui Pei, Weiliang Wu, PanPan Zhao, Libing Tian, Shu-Feng Zhou

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

Removing Gaps in Data Integrity

Agnes Shanley

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

Up-to-Date Systems Streamline Operations

Amber Lowry

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

A Biologics Partisan Divide

Rita C. Peters

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

FDA Revamps Biosimilar Quality Requirements

Jill Wechsler

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
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| PERSPECTIVES ON OUTSOURCING |

Gene Therapies Propel Outsourcing Investment

Susan Haigney

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

Playbooks Are Not Just Child's Play

Siegfried Schmitt

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.
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