BioPharm International’s June Issue: Can Nanotechnology Deliver Big Drug Benefits?

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June 2019
Volume 32, No. 6

| COVER STORY |

Can Nanotechnology Deliver Big Drug Benefits?

Feliza Mirasol

Research advances have enabled the application of nanotechnology to drug delivery. What does this technology offer in the way of enhancing therapeutic effect?
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| DEVELOPMENT |

Taking Therapeutic Antibodies to the Next Level

Feliza Mirasol

This article explores the challenges and potential of next-generation therapeutic antibodies.
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| UPSTREAM PROCESSING |

Streamlining Upstream Processing: A Good Place to Start

Felicity Thomas

As cost and time pressures within biopharma are on the rise, innovative expression systems may offer companies a good opportunity to streamline processes early on.
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BioPharm International June Issue

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| DOWNSTREAM PROCESSING |

Addressing the Complex Nature of Downstream Processing with QbD

Susan Haigney

Quality by design brings both challenges and benefits to the development of downstream processes.
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| PEER-REVIEWED |

Comparing Facility Layout Options for Managing Business and Operating Risks

Mark Witcher, Harry Silver

The authors present a risk analysis of the impact of various business and operating risks on three facility layout strategies.
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Process Development Forum
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| DATA ANALYTICS |

From Data to Information

Agnes Shanley

Making siloed data accessible across functions and to contract partners is the first step to facilitating continuous improvement and enabling use of artificial intelligence in manufacturing.
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| OPERATIONS |

Moving PAT from Concept to Reality

Cynthia A. Challener

The learning curve for process analytical technology has slowed widespread adoption.
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| SUPPLY CHAIN |

On the Right Track

Felicity Thomas

Proactive approaches that consider long-term supply chain security compliance are recommended to ensure companies stay on the right track.
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| FROM THE EDITOR |

Bio/Pharma Facilities Still Have a Lot to Learn

Rita C. Peters

FDA's annual manufacturing report card shows more quality compliance is needed.
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| REGULATORY BEAT |

FDA Advances New Approach to Drug Quality Assessment

Jill Wechsler

CDER's KASA program seeks manufacturer data on drug attributes and risks to inform oversight.
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| ASK THE EXPERT |

Quality Agreements and Out-of-Specification Investigations

Siegfried Schmitt

A good working relationship between sponsor and contractor will become invaluable when an OOS occurs, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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