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American Pharmaceutical News In Review
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March 02, 2021
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  Webinar: Meeting the Evolving Requirements of Pharmaceutical Waters with Proactive Process Control

In pharmaceutical water process monitoring, there is a need to change operating philosophy from reactive to proactive. This provides better transparency and increases the ability to better control water quality. Real time, continuous feedback on TOC ensures that TOC content of water remains low and can eliminate the struggle with biofilm formation and the risks it presents in pharma water quality. Click Learn More to register for this webinar.

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» Industry News
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  FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine
The FDA issued an EUA for the third vaccine for the prevention of COVID-19. read more »
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  AIVITA Completes Phase 1 Study of Personalized COVID-19 Vaccine Candidate
AIVITA announced the completion of a Phase 1 clinical study in Indonesia of its personalized vaccine... read more »
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  Independent Data Monitoring Committee Finds Efficacy for REGEN-COV
Regeneron announced changes to the Phase 3 trial assessing investigational REGEN-COV in outpatients ... read more »
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  HUMIRA Receives FDA Approval to Treat Pediatric Patients with Ulcerative Colitis
AbbVie announced the FDA approved HUMIRA for the treatment of moderately to severely active ... read more »
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  FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation
The FDA granted approval for Amondys 45 injection for the treatment of Duchenne muscular dystrophy ... read more »
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  Contec Hosts International Panel in Cleanovators Special Event
On March 18, leading experts in infectious disease, public health, public policy, and contamination ... read more »

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» QC Corner
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 »
QC Corner
  Rise of Single-Use Bioprocessing Technologies: Dominating Most R&D and Clinical Manufacture
In recent years, the application of single-use technologies in the bioprocessing industry has become... read more »

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» Featured Articles
In-Situ Disinfectant Validation Case Study
One of the key quality attributes for evaluating effectiveness of the cleaning and disinfection program is the in-situ validation. The requirement can... read more »
Sample Sizing Approaches for Container Closure Integrity (CCI) Testing
Sample size approaches for container closure integrity testing (CCIT) for routine commercial biopharmaceutical production vary across the industry. ... read more »
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» Featured Video
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  On-Demand Webinar: Introducing the Latest Technology in Bioburden Testing
In this webinar you’ll learn about the improvements made to reduce the chance of cross contamination, improvements made to assist with traceability, ... watch »
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  On-Demand Webinar: A Successful Journey to Cell Therapy Manufacturing: From R&D to Lot-Release
In this webinar you'll learn about regulatory requirements for GMP ancillary materials for cell and gene therapy, closed-system manufacturing and how ... watch »

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» Featured Products
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  MB-Rx Insitu Reaction Monitoring Analyzer
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  KICCOLATE Croscarmellose Sodium
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» Featured Whitepaper
White paper: Making the Switch to In-House Mycoplasma Testing
Octapharma AB in Stockholm, Sweden, is the site for the NUWIQ® production, a recombinant human FVIII produced in human cells. Regulatory guidelines state that recombinant bulk harvest must be tested ... read more »
Microbiology and More - Unleashing the Power of the MODA-EM Solution
Challenge: Capturing QC data electronically in a single system When setting up their facility in Tokyo, Japan, NCLi wanted to maximize the efficiency of their quality control (QC) laboratories by ... read more »

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| Events
EVENT
  Crush Particle Analysis Problems with Hound
Online –  03/11/2021
Materials and particle characterization are critical for assessing quality.
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EVENT
  SMi’s 2nd Annual AI in Drug Discovery
Online –  03/15/2021
Chaired by: Darren Green, Director of Molecular Design & Senior Fellow, GSK Sponsored by: Cas Group & Dassault Systèmes Exploring the latest ...
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