| DEVELOPMENT |

Managing Excipient Interactions

The key is to ensure that excipients only interact with APIs via desired mechanisms.
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Tackling Solubility in Drug Development

Spray drying is a versatile and rapid technique that can provide companies with a suitable and scalable option to improve the solubility and bioavailability of drug products.
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| MANUFACTURING |

Visualization Enhances Facility Design

Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.
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| ANALYTICS |

Meeting E&L Expectations

As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
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| QUALITY/REGULATIONS |

Applying Lessons Learned from the Semiconductor Industry

Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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| PEER-REVIEWED RESEARCH |

Approaches to Reduced Sampling and Testing for Starting Materials

Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.
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| FROM THE EDITOR |

Fighting the Good Fight

Nearly four decades after the first diagnosis, the fight to treat HIV/AIDs continues.
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| US REGULATORY WATCH |

Quality Issues Offset Biomedical Advances

Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.
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| ASK THE EXPERT |

Investigating Combination Product Failures

Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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