| COVER STORY |

Evaluating the Rewards vs. the Risks of Automation

Cynthia A. Challener

Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.
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| UPSTREAM PROCESSING |

Elements in Raw Materials May Impact Product Quality

Susan Haigney

Trace elements in raw materials may impact the quality and safety of the finished biologic product, according to industry experts.
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| PEER-REVIEWED |

Study on an Inactivation Evaluation Method of Cleaning Processes for Biopharmaceuticals

Takashi Kaminagayoshi, Kosuke Takenaka, Tetsuya Ohta, Tomohiro Doi, Makoto Sadamitsu, Shunsuke Omori, Shinji Tsuji, Yoshiaki Miko, Osamu Shirokizawa, Andrew Walshi

This study was successful in establishing a reliable and effective method for evaluating cleaning processes based on risk.
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BioPharm International September 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 ››

| QUALITY BY DESIGN |

QbD in the Development of ADCs with PBD Dimer Warheads

Srinath Thirumalairajan, Jesse Novak, Sanjeevani Ghone

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.
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| MICROBIAL CONTAMINATION |

Ensuring Viral Safety of Viral Vaccines and Vectors

Anissa Boumlic, Martin Wisher, Damon Asher, Priyabrata Pattnaik

Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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| INTELLECTUAL PROPERTY |

Patenting Antibodies in Europe

Monika Rai, Juliet Redhouse

Although there are some similarities between the way that US and European authorities uphold antibody patents, there are also some important differences.
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| FROM THE EDITOR |

Be a Part of the Solution

Rita C. Peters

Sharing of bioprocessing know-how can help resolve pressing industry problems.
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| REGULATORY BEAT |

FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies

Jill Wechsler

More consistent and reliable production processes are critical for advancing innovative treatments.
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| PERSPECTIVES ON OUTSOURCING |

Biopharma Demand Continues to Influence CMO Actions

BioPharm International Editors

Partnerships, mergers, and new services indicate that biologics are continuing to influence CMOs' and CDMOs' decisions to expand their biopharmaceutical services.
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| ASK THE EXPERT |

Checking Incoming Goods

Siegfried Schmitt

Detailed process descriptions and robust documentation aid in compliance as well as training, says Siegfried Schmitt, principal consultant at PAREXEL.
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UPCOMING WEBCASTs

Using High-Throughput Automation to Accelerate Biologic Drug Formulation
Thursday October 25, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Protein A Chromatography: Important Features in Purification to Reduce mAb Aggregation and Increase Recovery
Tuesday, October 23, 2018 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Screen Hundreds of N-Glycans per Day: More Samples – Better Decisions – Faster
Europe Broadcast: Thursday, October 4, 2018 at 2pm BST | 3pm CEST
US Broadcast: Thursday, October 4, 2018 at 11am EDT | 10am CDT | 8am PDT>br/> Asia Pacific Broadcast: Friday, October 5, 2018 at 11am CST | 12pm JST | 1pm AEST
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