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Pharmtech
May 2019
Volume 31, No. 5
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| COVER STORY |

The Search for Bioprocess Productivity Improvement

Feliza Mirasol

Large biopharmas, emerging biotechs, and CMOs are looking for novel ways to improve the productivity of biologics in a rapidly evolving biotherapeutics market.
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| EXCIPIENT VARIABILITY |

Avoiding Excipient Variability

Cynthia A. Challener

Knowing the source and understanding the impact on CQAs is crucial to optimum drug formulation and processing.
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| FORMULATION |

Role of Particle Morphology on Tablet Dissolution Rates

Renato BP Pinto, Anderson Albuquerque, Raphael Lopes

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water soluble drug substance, has an influence on the dissolution rate of compressed tablets.
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PharmTech Europe May Issue
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| ASEPTIC MANUFACTURING |

Closed Systems for Aseptic Fill and Finish

Jennifer Markarian

Isolators, robotics, and other new technologies are ready to modernize aseptic pharmaceutical filling and packaging.
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| MANUFACTURING |

Single-Use in 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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| PEER-REVIEWED RESEARCH |

Testing for Water in DMSO: Exploring Alternatives to Volumetric Karl Fischer Analysis

Andrew Johnson, Ashley Jones

In Karl Fischer analysis, sulfur trioxide can react with DMSO, invalidating test results. The authors evaluated different instruments and methods, described in this article, to minimize the impact on results.
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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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| PACKAGING |

Contract Packaging Grows

Hallie Forcinio

Contract packagers expand operations and services to accommodate growing need.
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| EUROPEAN REGULATIONS |

A Meeting of Minds

Felicity Thomas

A new conference is set to provide a platform for European regulatory professionals to come together to discuss relevant issues and share expertise.
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| OUTSOURCING |

Bioprocessing Facilities and FDA Inspection Problems

Ronald A. Rader

FDA inspections can create uncertainty. Supervision of the contract manufacturer is crucial in ensuring compliance.
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| EDITOR’S COMMENT |

Broadening Europe’s Research Horizons?

Felicity Thomas

Horizon Europe gains parliamentary endorsement, bringing it closer to becoming a reality.
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| EUROPEAN REGULATORY WATCH |

Playing the Waiting Game with GMP Guidelines Revisions

Sean Milmo

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.
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| ASK THE EXPERT |

The Auditor Vs. Inspector Issue

Siegfried Schmitt

We need to understand both sides when it comes to audits, says Siegfried Schmitt, PhD, vice-president, technical, PAREXEL Consulting.
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| EVENTS |

Injectable Drug Delivery 2019

London, UK
15–16 May 2019

Advanced Therapy Medicinal Products Conference

Vilnius, Lithuania
4 June 2019

4th PDA Europe Annual Meeting

Amsterdam, The Netherlands
25–26 June 2019

more events

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