BioPharm International’s May Issue: Formulating Biologic Drugs for Sterile Fill/Finish

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May 2019
Volume 32, No. 5

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| COVER STORY |

Formulating Biologic Drugs for Sterile Fill/Finish

Cynthia A. Challener

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.
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| BIOSIMILARS |

Challenges with Successful Commercialization of Biosimilars

Anurag S. Rathore, Arnold G. Vulto, James G. Stevenson, Vinod P. Shah

This article presents some key differences between the US and European regulation of biosimilars, including naming conventions and pharmacovigilance of biosimilars, and the impact of biosimilars on commercialization and affordability of biotherapeutics.
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| UPSTREAM PROCESSING |

What's New in Upstream Technologies

Amber Lowry

Recent upstream processing innovations include enhanced sensor technology, single-use bioreactors, and automated cell culture systems.
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BioPharm International May Issue

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| DOWNSTREAM PROCESSING |

Single-Use for Downstream Chromatography: Benefit or Hindrance?

Feliza Mirasol

Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
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| ASEPTIC MANUFACTURING |

Optimizing Diaphragm Valves to Improve Bioprocess Reliability

Paul McClune

Valve design and materials affect performance and cost to maintain.
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| QUALITY CONTROL |

Getting a Handle on Biopharma's Most Critical Quality Attributes and Quality Control

Agnes Shanley

Broad efforts are underway to determine biopharmaceuticals' most significant critical quality attributes and enable real-time release.
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| ANALYTICS |

Managing Biologic Equipment Cleaning

Feliza Mirasol

This article takes a look at current practices for cleaning and sterilizing biomanufacturing equipment used in a multi-product versus single-product setting.
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