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BioPharm
April 2020
Volume 33, No. 4
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| COVER STORY |

Can Vaccine Development Be Safely Accelerated?

Cynthia A. Challener

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.
read more


| UPSTREAM PROCESSING |

Bioreactors Redefine Upstream Productivity

Agnes Shanley

New bioreactor designs, coupled with better media, process intensification and analytics, continue to improve upstream bioprocessing.
read more


| DOWNSTREAM PROCESSING |

What’s New in Downstream Technologies

Lauren Lavelle

The latest advances in downstream technologies include a fluid chromatography system, sensing and control units for hygienic valves, a compact valve platform, a membrane purification column, and a protein A affinity chromatography resin.
read more


BioPharm International April Issue
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| MANUFACTURING |

Seeing Success with Single-Use Solutions

Felicity Thomas

Single-use solutions continue to grow in popularity, largely as a result of the cost and time efficiencies they can afford biopharma companies.
read more


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Featured Resources from BioPharm International
View our online resource center, sponsored by GE Healthcare, to explore a case study and articles on gaining and retaining skilled labor, modular bioprocessing, the good and bad of biosilimiars, and more.
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| ANALYTICS |

Contamination Control for Cell Therapy

Felicity Thomas

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.
read more

| QUALITY/REGULATIONS |

Biosimilars Tackle Interchangeability Standards

Feliza Mirasol

Demonstrating interchangeability can ensure biosimilar substitutability at the pharmacy level.
read more


| OPERATIONS |

Being Vigilant in Supplier Oversight

Susan Haigney

Risk assessments, audits, and good communication between sponsor and supplier are key elements of supplier oversight.
read more


Packaging Preserves the Cold Chain

Hallie Forcinio

More sustainable and functional packaging protects temperature-sensitive drugs.
read more


On Point: Biologics Drive Growth in Pre-Filled Syringes

Felicity Thomas

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.
read more


| OUTSOURCING |

Ensuring Smooth Tech Transfer of Bioprocess Operations

Cynthia A. Challener

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.
read more


| BIOBUSINESS |

Lower Taxes, More Flexibility Crucial to Retaining Pharma Employment

Agnes Shanley, Lauren Lavelle

As politicians focus on drug cost reduction, biopharmaceutical companies in the US are moving to states with lower taxes and relocating some facilities that had been offshore.
read more


| FROM THE EDITOR |

Biopharma’s Leadership Role in a Pandemic

Rita C. Peters

As the coronavirus pandemic unfolds, the bio/pharma industry must practice science over hype.
read more


| REGULATORY BEAT |

Biosimilars Poised for Gains in US Market

Jill Wechsler

FDA is encouraging alternative insulins and challenging anticompetitive practices.
read more


| ASK THE EXPERT |

Critical Knowledge for Preparing Audits

Susan J. Schniepp

N Addressing data integrity, quality culture, aging facilities, investigations/corrective actions and preventive actions, and risk management is key when conducting audits, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
read more



WEBCASTS

Simple and Effective Methods for Purification and Determination of Molecular Weight of DMT-on and DMT-off Oligonucleotides
Wednesday, April 22, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
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Implementing Attribute Monitoring Analyses for Biopharmaceutical Development and QC
Wednesday, April 29, 2020, 9am EDT| 2pm BST| 3pm CEST
Register now


| EVENTS |

BIO Digital

June 8–12, 2020

CPhI China

June 22–24, 2020

Interphex 2020

July 15–17, 2020

more events

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