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BioPharm
January 2019
Volume 32, No. 1
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| COVER STORY |

Identifying Incentives to Adopt Advanced Manufacturing

Rita C. Peters

Bio/pharma companies are successfully launching novel therapies; however, the industry still needs to work on manufacturing innovation.
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| SPECIAL REPORT: EMPLOYMENT SURVEY |

Matching Personal and Company Success

Rita C. Peters

Compensation and professional challenges are key pieces to solving the biopharma employee satisfaction puzzle.
read more


| UPSTREAM: CELL CULTURE |

The Role of Automation in Cell-Line Development

Feliza Mirasol

Automation in cell-line development and cell culture is leading to more consistent quality while improving efficiency, and, ultimately, speed to market.
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BioPharm International January Issue
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| DOWNSTREAM: SEPARATION AND PURIFICATION |

A Look at the Affinity Chromatography Landscape

Cynthia A. Challener

New ligands are being developed to meet the separation and purification needs of next-gen biologics.
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| PEER-REVIEWED |

Efficacy of a Simple Static Cleaning Procedure for SPTFF

Torsten Bisschop, Karen Chan, and Herb Lutz

This article highlights a case study in which a static cleaning methodology was applied for SPTFF.
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| FACILITY DESIGN |

The Impact of Expedited Review Status on Biomanufacturing Facility Design

Jeff Odum

For rapid scale-up, facility design must better integrate product development and manufacturing lifecycle activities.
read more


| STABILITY TESTING |

Modeling the Degradation of mAb Therapeutics

Anurag S. Rathore, Rohit Bansal

Kinetic models can be used to study aggregation and fragmentation to help ensure stability.
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| FROM THE EDITOR |

Internal and External Challenges to Biopharma in 2019

Rita C. Peters

Pricing pressures, investment volatility, and government dysfunction greet Biopharma in 2019.
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| REGULATORY BEAT |

CDER Priorities for 2019: Opioids, Quality, Safety, and Innovation

Jill Wechsler

FDA plans to support initiatives to ensure that all medicines are safe, effective, and of high quality.
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| PERSPECTIVES ON OUTSOURCING |

The Outlook for CMO Outsourcing in 2019

Ronald A. Rader and Eric S. Langer

Outsourcing of manufacturing activities is expected to increase in 2019.
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| ASK THE EXPERT |

Global Inspection Harmonization

Siegfried Schmitt

Understanding the differences in inspection processes is the key to successful global expansion.
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LIVE WEBCAST

Understanding Absolute Stoichiometry of Oligomeric Protein Complexes using SEC-MALS
Tuesday, January 29, 2019 at 11am EST| 8am PST| 4pm GMT| 5pm CET
Register now


| EVENTS |

2019 PDA Annual Meeting

March 11–13, 2019

Pittcon 2019

March 17–21, 2019

DCAT Week '19

March 18–21, 2019

more events

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