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American Pharmaceutical News In Review
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December 09, 2020
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  Take a Tour of Eurofins’ Category 5 Laboratory

Control your ADC free-drug testing at the industry’s only laboratory network for highly potent compounds of its kind. The addition of Category 5 testing areas within the Eurofins network in Lancaster, PA, and Columbia, MO, allow for specific stability and release testing to be performed on finished products that present safety challenges for traditional chemistry laboratories. Discover how together we can target diseases and make the world healthier and safer.

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» Industry News
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  Sotira Completes Pre-Clinical Testing for COVID-19 Vaccine Alternative
Sotira has announced the successful completion of the second phase of pre-clinical testing for its ... read more »
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  Potential Treatment from ARCA for COVID-19 Receives Fast Track Designation
ARCA biopharma announced the FDA has designated as a Fast Track development program the ... read more »
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  FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
The FDA expanded the approved indication for Xofluza to include post-exposure prevention of ... read more »
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  NIAID Selects Metabolon for COVID-19 Study
Metabolon will participate in the NIAID, part of the National Institutes of Health, ... read more »
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  Neurelis Completes Pre-IND Meeting with FDA for Acute Agitation Treatment
Neurelis has concluded a pre-IND Application meeting with the FDA regarding NRL-4. read more »
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  MapLight Completes Dosing in Phase 1 Study for Social Deficit in Autism
MapLight Therapeutics has completed dosing of healthy volunteers across five cohorts in a Phase 1 ... read more »

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» QC Corner
QC Corner
  Analysis of FDA Enforcement Reports (2012-2019) to Determine the Microbial Diversity in Contaminated Non-Sterile and Sterile Drugs
An analysis of FDA enforcement reports from 2012 to 2019 showed that Gram-negative bacteria were the... read more »
QC Corner
  Perfusion Medium Development for Continuous Bioprocessing of Animal Cell Cultures
Traditional bioprocesses of mammalian cell cultures are operated in batch- or fed-batch mode. To ... read more »

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» Infographic
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  How to Maximize Viral Clearance in a Membrane-Based Process
Product safety is a big concern in biopharmaceutical manufacturing. Specifically, virus contamination in biopharmaceutical products is critical to ... read more »
» Featured Articles
The Truth of Endotoxin Values - Points for Consideration During Investigation of Aberrant BET Results
Bacterial Endotoxin Testing (BET) is mandatory for detection of Endotoxin/Lipopolysaccharides (LPS) in parenteral drug products. This is important as ... read more »
The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration: A PDA and BioPhorum Collaboration
Pre-Use/Post-Sterilization Integrity Testing (PUPSIT) continues to be a much-discussed topic in the manufacture of sterile pharmaceutical and ... read more »
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» Featured Video
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  On-Demand Webinar: Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
In this webinar, you will learn more about current regulatory requirements for residual host DNA clearance for biological products and what that means... watch »
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  On-Demand Webinar: TOC Method Madness: Is there a method to your validation madness?
In this webinar you'll learn about determining acceptance criteria, what compounds can and cannot be analyzed using TOC, why recovery studies are ... watch »

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» Featured Products
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  MB3000-PH FT-IR Analyzer
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  APAF-BP AdvantaFlex™ Biopharmaceutical Grade TPE Tubing
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» Featured Whitepaper
Reformulation into Long-Acting Injectables and Implants
Long-acting, drug delivery products based on PLG-parenteral functional excipients have been used to reformulate and repurpose more than 60 drugs. This white paper reviews the conversion of oral and ... read more »
Recognizing the Potential Impact of Agitation Directionality On Oxygen Mass Transfer Through a kLa Evaluation Within the BIOne Single-Use Bioreactor
Defining a suitable agitation strategy is essential for the successful development of upstream mammalian bioprocesses. read more »

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| Events
EVENT
  Sustainability In Bacterial Endotoxin Testing
Online –  12/10/2020
Horseshoe crabs in the United States are regulated and monitored carefully.
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EVENT
  Solid Form Analysis: In-depth Understanding of API’s Behavior
Online –  12/16/2020
Solid form analysis plays a vital role in material’s characterization throughout the whole pharmaceutical development cycle.
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