| PROTEIN THERAPEUTICS DEVELOPMENT |

Transcriptomics and the Production of Recombinant Therapeutics

Transcriptomics plays a role in influencing the production of recombinant therapeutics in microbial and mammalian hosts.
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| QUALITY |

Understanding Validation and Technical Transfer, Part 3

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.
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| ANALYTICS |

Rapid Adventitious Agent Testing Remains a Real Need

More advanced NGS-based techniques still require validation and regulatory acceptance.
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| SUPPLY CHAIN |

Meeting the Challenge of Patient-Centered Clinical Trials

Logistics manufacturers are adapting to explosive growth in the use of direct-to-patient clinical trials. Michael Sweeney, director of patient-centric logistics at World Courier Group, discusses the new model's impact.
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| FROM THE EDITOR |

Let the Learning Commence

By minding gaps in industry knowledge, bio/pharma companies can avoid development pitfalls.
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| REGULATORY BEAT |

Manufacturers Under Pressure to Curb Opioid Use and Abuse

FDA and Congress seek to limit the production and distribution of pain medicines.
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| PERSPECTIVES ON OUTSOURCING |

CMOs Expand Manufacturing Capacities

New and expanded facilities point to the continuing growth of the biopharmaceutical industry.
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| ASK THE EXPERT |

Outsourcing Analytical Methods

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
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