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BioPharm
June 2020
Volume 33, No. 6
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Notice to BioPharm International subscribers currently receiving printed copies of the magazine:

Many readers working remotely may not have access to the print versions of BioPharm International; therefore, for upcoming issues, we will deliver the digital version of the magazine to you via email. Your print issues will continue to be delivered to you via postal mail and will be awaiting your return to the office. If you wish to change your delivery address, or delivery preference, you can do so via our online subscription form.
 

| COVER STORY |

New Tools Facilitate Automated Process Control

Jennifer Markarian

Automated sampling systems and integration of PAT are overcoming some of the roadblocks to increased automation of biopharmaceutical manufacturing processes.
read more


| UPSTREAM PROCESSING |

Plasma-Based Antibody Therapies Battle Against COVID-19

Cynthia A. Challener

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.
read more


| DOWNSTREAM PROCESSING |

Challenges, Tools, and Strategies for Data
Integrity Protection

Feliza Mirasol

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.
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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BioPharm International June Issue
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| PEER-REVIEW RESEARCH |

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

Jun Luo, Sid Kundu, Yiming Peng, Jesse Bergevin

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.
read more


| OPERATIONS |

Finding New Efficiencies in Clinical Trial Logistics

Agnes Shanley

The COVID-19 pandemic has led to increased demand for direct-to-patient shipments, challenging cold-chain specialists to become more agile and to strengthen their global distribution networks.
read more


| ANALYTICS |

The Importance of Partnering for Bioanalytical Studies

Feliza Mirasol

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
read more


| BIOBUSINESS |

The Role of Incubators in Cell and Gene Therapy Development

Lauren Lavelle

Working with incubators can provide cell and gene therapy developers with more opportunities.
read more


| FROM THE EDITOR |

Are We All In This Together?

Rita C. Peters

Achieving herd immunity will require testing, data, a vaccine, and public support.
read more


| REGULATORY BEAT |

Generic Drugs in Spotlight as Pandemic Creates Shortages

Jill Wechsler

FDA and the US Congress support innovation and access to cheaper medicines.
read more


| ASK THE EXPERT |

Following Guidelines During a Crisis

Susan J. Schniepp

Products must be manufactured in accordance with appropriate regulatory requirements, even during a pandemic, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
read more



WEBCASTs

Validation of an LC-MS Multi-Attribute Method (MAM) Supporting Biopharma Process Characterization
Tuesday, June 30, 2020 at 10am EDT | 9am CDT | 2pm BST | 3pm CEST
Register now


| EVENTS |

BIO Digital

June 8–12, 2020

Validation University

August 24–26, 2020

CPhI Japan

September 30–October 2, 2020

more events

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