Realizing the Potential of Vaccines

As vaccines gain prominence within pharma, there is an expectation that specialized CDMO services will provide opportunities.
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Analysis and Purification: Instrumental to BioPharma

To deal with the complex requirements of biopharmaceuticals, companies need a sophisticated toolbox of analytical and purification techniques.
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Tooling Up for Pharma

Instrumentation advancements over the past 30 years have certainly enabled greater efficiency in pharma development and analysis despite slow adoption by the industry.
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Farther Than the Eye Can See

Machine vision systems have been an integral part of pharma manufacturing and packaging for many years and, with the introduction of stricter safety regulations, are set to become more vital.
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Niche APIs By Popular Demand

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.
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Raise a Glass to Pharma Vials

Glass vials have come a long way from mere commodities and are now considered an integral part of final drug product.
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Regulatory Harmony

Harmonization of regulatory guidelines not only reduces workloads for manufacturers and regulators but can potentially help to accelerate patient access to vital therapies.
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|EXCIPIENTS |

Combo Drugs Require a Complex Design Approach

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.
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| FORMULATION |

Formulation and Manufacturing Trends for Parenterals

Formulators of parenteral drugs must be cautious of specific considerations during development and manufacture.
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| SOLID-DOSE MANUFACTURING |

Blending Trace Ingredients

Homogeneity of the powder blend is crucial for solid-dosage drug manufacturing.
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| PEER-REVIEWED RESEARCH |

Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method

The ZipChip CE-ESI interface is evaluated for suitability as a platform approach for quantitation of MIs in API.
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| CLINICAL TRIAL MANUFACTURING AND LOGISTICS |

Orchestrating Success in Clinical Trial Manufacturing

Experts share best practices for managing clinical trials manufacturing and logistics.
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| cGMPs |

US FDA Steps Up cGMP Enforcement for OTC Drugs

Senior managers of OTC drug companies are on a learning curve, as US FDA warning letters cite insufficient understanding of cGMPs and inadequate responses to prior 483s.
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| ANALYTICS |

Accepting the Challenge of Protein Characterization

Industry needs to look to technological advances to meet the specific requirements of complex molecule characterization.
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| STANDARDS AND REGULATIONS |

The Great Divide? Implications of the SPC Waiver

Europe has introduced a waiver for supplementary protection certificates, polarizing opinions throughout the industry. In this interview, the SPC waiver and its implications for European pharma are discussed.
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| EDITOR'S COMMENT |

Celebrating in Style

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.
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| EUROPEAN REGULATORY WATCH |

One Small Step for Man, One Giant Leap for Pharma Regulators

European Union regulators have taken a significant step towards resolving some of the major supply-chain difficulties behind medicine shortages.
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| ASK THE EXPERT |

Quality Risk Management Plans Create Effective Quality Systems

Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products.
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