| API SYNTHESIS & MANUFACTURING |

Optimizing Cell-Culture Media

Media manufacturers are focused on reducing risk, improving quality and consistency, and managing costs.
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| FORMULATION |

Targeting Drug Delivery with ADCs

Safe and effective drug targeting with ADCs requires careful selection of drug, antibody, and linker.
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| MANUFACTURING |

Using QbD in Topical Drug Manufacturing

Characterization of the product and process is key for process development and scale-up of topical drug manufacturing using a QbD approach.
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| ANALYTICS |

A Continuous Improvement Metric for Pharmaceutical Manufacturing

Statistical methods and novel indices can be used to monitor and benchmark variability, and guide continuous improvement programs in late-stage drug development.
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| QUALITY |

Avoiding Investigational Failure/Discrepancy-Related Form 483 Observations

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.
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| PEER-REVIEWED RESEARCH |

Establishing Acceptance Limits for Uniformity of Dosage Units: Part Two

The author describes how to establish acceptance limits for acceptance value (AV) data for process validation batches, typical characteristics of AV distributions, and how to derive relevant constants for AV control charts in annual product review and continued process verification reports.
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| EU REGULATORY WATCH |

EMA Increases Support for SMEs

EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
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| ASK THE EXPERT |

A Look at Batch Record Review

The review of batch records creates a story of the materials, manufacturing, and packaging involved in the production of bio/pharmaceuticals, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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