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Month 2016
Volume 29, No. 4

| COVER STORY |

Continuous Processing for the Production of
Biopharmaceuticals

Anurag Rathore, Nikhil Kateja, Harshit Agarwal, Abhishek Kumar Sharma

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.
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| OUTSOURCING |

CMC Development is Hot

Jim Miller

Demand is driving expansion and consolidation of formulation and clinical trial materials services.
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| REGULATORY |

Vaccine Development Faces Urgency and
Challenges

Jill Wechsler

Global outbreaks energize vaccine R&D and drive production modernization.
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| COMPLIANCE NOTES |

Integrating Technology Transfer and Facilities Startup for Biologics

Walter Matzmorr

Careful planning, adequate staffing levels, and experienced project managers can help avoid pitfalls of transferring processes from one facility to another.
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BioPharm International XXXXMONTHXXXX Issue

| PEER-REVIEWED RESEARCH |

Size-Exclusion Chromatography for Preparative Purification of Biomolecules

Andreas Stein, Anja Heinen-Kreuzig, André Kiesewetter, Sebastian Schwarm

The authors provide application data to support the use of SEC beyond small-scale operations.
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| FROM THE EDITOR |

Behind the Scenes in Vaccine Development

Rita C. Peters

Proven science-based strategies can help to accelerate vaccine development.
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| ANALYTICAL BEST PRACTICES |

Essentials in Bioassay Design and Relative Potency Determination

Thomas A. Little, PhD

The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.
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| TROUBLESHOOTING |

A Review of the Challenges of Delivering Macromolecule Biologicals

Andy Fry

Selecting a delivery method early on may be beneficial.
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| ADVENTITIOUS AGENTS |

Modeling the Efficacy of HTST for Inactivating Mouse Minute Virus

Mark Plavsic, Raymond W. Nims

The authors investigate discrepancies in the reported efficacy of high-temperature short-time treatment for inactivating mouse minute virus.
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| BIOPROCESSING |

Lessons Learned Accelerate Vaccine Development

Cynthia A. Challener

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
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| UPSTREAM PROCESSING |

Platform Approach Speeds Process Development

Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig

A modular cell-culture platform demonstrates accelerated process development.
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| DOWNSTREAM PROCESSING |

The Importance of Buffers in Downstream Processing

Susan Haigney

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.
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| WEBCASTS |

Innovative Tools for the Development and Manufacturing of Biotherapeutic Proteins

On Demand
The biopharmaceutical industry has seen ever increasing innovation over the past five years. Most notably, there has been an increase adoption of high-throughput process development (HTPD) and single-use technologies. Join our webinar to learn effective strategies to match product quality attributes for a biosimilar product and reduce process development timelines.
Sponsored by Patheon

Hydroxyapatite Separation of Monoclonal Antibodies and Antibody Fragments

On Demand
Join us for a discussion on the use of hydroxyapatite in mAb and mAb fragment purification processes.
Sponsored by Tosoh Bioscience LLC

more webcasts