| COVER STORY |

Maintaining Cell Line Integrity

Feliza Mirasol

The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
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| UPSTREAM PROCESSING |

The Search for Next-Gen Expression Systems

Cynthia A. Challener

Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
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| DOWNSTREAM PROCESSING |

Expectations for Residual Impurity Analysis Continue to Rise

Cynthia A. Challener

More complex biologic samples must be evaluated to ever higher levels of specificity and sensitivity.
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BioPharm International August Issue

Process Development Forum
Need to optimize your manufacturing systems? Find insights, solutions, and shortcuts in bioprocessing at ProcessDevelopmentForum.com.
Click here to access the site ››

| MANUFACTURING |

A New Paradigm in Drug Development

Pascale Bouillé

The changing regulatory and manufacturing environment is ushering in a new approach to drug development.
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| ANALYTICS |

E&L Risk Assessment for Biologic Drug Products

Adeline Siew, PhD

Materials in contact with a drug must be fully characterized to ensure they do not negatively affect the safety and efficacy of the product.
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| FROM THE EDITOR |

FDA Is Not Playing Games with Biosimilars

Rita C. Peters

Frustrated by slow market adoption, Gottlieb maps out a new plan for biosimilar competition.
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| REGULATORY BEAT |

FDA Seeks to Revive Quality Metrics Initiative

Jill Wechsler

FDA is asking firms to discuss internal quality metrics efforts as part of the approval process for new medical products.
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| ASK THE EXPERT |

Submitting Extractables and Leachables Data to Regulators

Susan J. Schniepp

The type of product, the packaging materials being used, and the process and materials used to manufacture the product will determine when E&L data should be submitted to regulators, says Susan J. Schniepp, executive vice-president, Post-approval Pharmaceuticals and distinguished fellow at Regulatory Compliance Associates.
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