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BioPharm
September 2016
Volume 29, No. 9
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| FOCUS |

Parenteral Advisory: Outmoded Fill/Finish Technology

Randi Hernandez

Improvements to aseptic manufacturing procedures are long overdue. But how feasible is it for manufacturers to modernize fill lines of legacy products?
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Puerto Rico: Regional difficulties related to fill/finish

Randi Hernandez

A company's fill/finish individual facilities can be negatively impacted by a region's economic climate, as currently observed at some of the pharmaceutical manufacturing locations in Puerto Rico.
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| BIOREACTOR PERFORMANCE |

Modeling Bioreactor Performance

Cynthia A. Challener

Model effectiveness is determined by the quality and composition of the data inputs.
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| PROTEIN CHARACTERIZATION |

Implementing a Dual Approach to Protein Characterization

Gunjan Choudhary, Laura Moriarty

Innovations in electrophoresis and chromatography upstream of protein characterization can accelerate research.
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| PEER-REVIEWED RESEARCH |

Part II: Enabling Freeze-Thaw Stability of PBS-Based Formulations of a Monoclonal Antibody

Tatyana Mezhebovsky, Eric Routhier, Philip Sass, Zahra Shahrokh

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.
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| DOWNSTREAM PROCESSING |

Process Chromatography Selection for Downstream Processing Applications

Caroline Hroncich

Industry experts discuss best practices for selecting a separation technology.
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|UPSTREAM PROCESSING |

Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology

Tom Fletcher, Holden Harris

Advances in cell culture media technology have helped achieve safer biologics.
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| GOOD DISTRIBUTION PRACTICES |

Manufacturing and Distribution Boundaries Blur

Agnes Shanley

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
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| OUTSOURCING |

Innovation vs. Capacity: How CMOs Compete

Jim Miller

The strategies of a innovation-driven CMO may be different than a capacity-driven CMO.
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| REGULATORY BEAT |

Efforts Accelerate to Streamline Postapproval Change Process

Jill Wechsler

Manufacturers and regulatory authorities seek coordinated lifecycle management policies.
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PDA Issues Call to Action for Faster Postapproval Changes

The Parenteral Drug Association develops program to address barriers to implementation of postapproval changes.
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| FROM THE EDITOR |

When Marketing and Medicine Collide

Rita C. Peters

Steep price increases for a popular drug have created patient and Congressional backlash.
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| PRODUCT SPOTLIGHT |

Analyzer Automates Cell-Culture Chemistry Analysis

The BioProfile FLEX 2 from Nova Biomedical is a cell-culture chemistry analyzer that allows for automated cell-culture analysis for small-volume culture systems.
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Data Logger Provides Ultra-Low Temperature Readings

The OM-CP-CRYO-TEMP ultra-low temperature data logger from Omega Engineering records temperatures as low as -86 °C.
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| Events |

2016 PDA Universe of Pre-filled Syringes and Injection Devices

October 17-18, 2016

BIO Europe 2016

November 7-9, 2016

AAPS Annual Meeting and Exposition

November 13- 17, 2016

more events

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