| MANUFACTURING |

The Case for Stainless Steel

Despite the growing popularity of single-use technologies in biomanufacturing, there are still instances where stainless steel is the better option.
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| QUALITY |

Moving From Compliance to Quality

Too narrow a focus on regulatory compliance may prevent organizations from embracing—and profiting from–quality and operational excellence.
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| ANALYTICS |

Accepting the Challenge of Protein Characterization

Protein characterization is a critical part of drug development, but as there are still limitations with available techniques, industry needs to look at technological advances to meet the specific requirements of complex molecule characterization.
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| CLINICAL TRIAL MANUFACTURING |

Orchestrating Success in Clinical Trial Manufacturing

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.
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| ANALYTICAL LAB OPERATIONS |

Best Practices in the QC Micro Laboratory

Strong personnel training, detailed SOPs, commitment to data integrity, investigation and implementation of appropriate modern methods, and employing Lean and Six Sigma methodology initiatives are key best practices for the quality control microbiology lab.
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| OUTSOURCING |

De-risking Biologics Development Through Advanced Mass Spectrometry Approaches

Using advanced HDX-MS and native MS techniques can improve the identification of potentially successful biologic drugs and de-risk CMC and clinical designs.
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| FROM THE EDITOR |

The Moon, the Stars, and the Science Lab

Half a century after man first walked on the moon, space-based science is exploring benefits for Planet Earth.
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| REGULATORY BEAT |

FDA Maps Strategies to Advance Cell and Gene Therapies

New tools and policies aim to support more complex manufacturing processes.
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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, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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