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Pharmtech
March 2018
Volume 30, No. 3
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| COVER STORY |

Can Early Development Strategies Avoid Later-Stage Disasters?

Rita C. Peters

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.
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| API SYNTHESIS AND MANUFACTURING |

Small Volumes, Big Challenges

Cynthia A. Challener

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.
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| PARTICLE ENGINEERING |

Dry Particle Coating—A Unique Solution for Pharmaceutical Formulation

Jasdip S. Koner, Eman Z. Dahmash, David A. Wyatt, Afzal Mohammed

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.
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PharmTech Europe March Issue
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| TOPICAL DRUG FORMULATION |

Formulating Topical Products Containing Live Microorganisms as the Active Ingredient

Jason Carbol, Pia Isabel Tan, Yug Varma, David W. Osborne

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.
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| ANALYTICS |

Stability Testing Determines Proper Drug Storage Parameters

Feliza Mirasol

Stability testing on APIs/finished drug product helps define optimal drug packaging for shelf-life storage.
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| PEER-REVIEWED RESEARCH |

A New Method for Risk Assessment of Pharmaceutical Excipients

Yurii Pidpruzhnykov, Olena Ruban, Tetiana Kolisnyk

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
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| QUALITY |

Expectations in Quality Agreements

Susan Haigney

Robert Iser of PAREXEL Consulting answers questions regarding the regulatory expectations of quality agreements and how companies can ensure the quality and safety of their products.
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| LAB OPERATIONS |

Improving Operations in the Lab

Amber Lowry

New and emerging products advance bio/pharma laboratory operations.
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| COLD-CHAIN DISTRIBUTION |

Poseidon Takes on the Pharma Supply Chain

Agnes Shanley

Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.
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| EUROPEAN REGULATORY WATCH |

Tackling Medicine Shortages in Europe

Sean Milmo

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.
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| US REGULATORY WATCH |

FDA Heightens Drive for Transparency

Jill Wechsler

Manufacturers tackle regulatory and competitive issues to develop complex therapies and biosimilars.
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| OUTSOURCING REVIEW |

Current Challenges in Bioprocesses Development

Ronald A. Rader

Development and adoption of new technologies create challenges that may take years to resolve.
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| ASK THE EXPERT |

Computerized Systems Validation

Siegfried Schmitt

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
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| EVENTS |

Paperless Lab Academy 2018

Milano, Italy
20–21 March 2018

Optimization of Cell & Gene Therapy Production Conference

Washington DC
26–27 March 2018

INTERPHEX

New York, New York
17–19 April 2018

more events

Take the survey

Biopharmaceutical Manufacturing Survey

Participate in BioPlan's 15th Annual Global Biopharmaceutical Manufacturing Study. Share your insight on current global and regional trends affecting biomanufacturing and BioPlan will donate $15 (up to $2,000) on your behalf to global health charities. Participants also receive a free aggregated summary of this year's results and an updated 15 Top Trends in Biopharmaceutical Manufacturing White Paper.

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