EDITOR'S DESK

Sterile Injectable Outsourcing Trends: What Biosimilar Developers Must Know

Though a majority of the data points in a recent ISR report on Sterile Manufacturing are not specifically focused around biosimilars, I reached out to the report’s lead author to unpack a handful of findings I thought would be important for those involved in both biologics and biosimilar manufacturing and outsourcing.  

Solving Pharma’s Public Opinion Crisis

Americans' view of the pharma industry is at an all-time low. NSF Health Sciences Global VP Martin Lush says to change that, something radical will have to happen.

Why EU’s New Med Device Regs Matter To Biopharma

Pharma's CMC regulatory affairs staff, R&D leadership, manufacturing, quality and compliance professionals take note: the EU MDR is real, it becomes effective next May, and it brings with it new challenges and regulatory uncertainty for manufacturers of combination products.     

FDA’s Woodcock: Biosimilar Development Promotes Future Of Better Biologics

While some regulators may express skepticism that we’ll see major changes to the clinical component of the biosimilar development pathway, Woodcock’s DIA keynote exemplified what I found to be a strikingly different attitude about the future possibilities for biosimilar development.

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BIOPROCESSING WHITE PAPERS

  • Using A CMO To Streamline Process Characterization
    Using A CMO To Streamline Process Characterization

    While traditional small molecule drug products usually consist of pure chemical substances that are easily analyzed after manufacture, biologics such as monoclonal antibodies (mAbs) are much more complex. 

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BIOPROCESS ONLINE CONTENT COLLECTIONS

DataIntegrity

 

This free collection of articles is from the Data Integrity In The Life Sciences series, the purpose of which is to highlight contemporary insights and relationships to key quality systems in order to elevate the most important topics and advance improvements in the collective quality culture.

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LIFE SCIENCE INDUSTRY EVENTS

Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Effective Batch Record Review – Getting It Right The First Time January 8 - 8, 2020
1:00pm - 2:30pm EST, Online Training
Clinical Research Project Management - 7 Breakthrough Behaviors For Success January 14 - 14, 2020
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Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error January 15 - 15, 2020
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TRAINING COURSES

Essentials of Disinfectant Efficacy Testing – Ensuring Microbial Control December 12 - 12, 2019
1pm-2:30pm EST, Online Training
Effective Batch Record Review – Getting It Right The First Time January 8 - 8, 2020
1:00pm - 2:30pm EST, Online Training
Clinical Research Project Management - 7 Breakthrough Behaviors For Success January 14 - 14, 2020
1pm-2:30pm EDT, Online Training
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error January 15 - 15, 2020
1pm-2:30pm EST, Online Training
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