| EUROPEAN BIO/PHARMA OUTLOOK |

Solving Pharma's Post-Brexit Puzzle

As Europe's bio/pharma market learns that breaking up is hard to do, it also must address productivity, regulatory, and drug pricing challenges.
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| FORMULATION: OLIGONUCLEOTIDES |

Characterization and Impurity Analysis of Oligonucleotide Therapeutics

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.
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| SINGLE-USE MANUFACTURING |

Point-of-Use Leak Testing of Single-Use Bag Assemblies

The authors describe the development and validation of a highly sensitive point-of-use pressure decay test.
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| GMP/GDP INSPECTIONS |

The GMP/GDP Inspection Landscape—Part I: Data

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has conducted an annual survey of GMP/GDP inspections at sites and affiliates among its member companies from 2003 until the present time. This article describes findings of the EFPIA annual survey of site inspections among its member companies.
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| PROCESS OPERATIONS |

Defining Quality: Joining the Quality Lab and the Plant Floor

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.
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| PEER-REVIEWED RESEARCH |

A Statistical Decision System for Out-of-Trend Evaluation

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.
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| OUTSOURCING REVIEW |

The Tide Stays High

Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
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