Microbial Solutions Digital Resources

During these uncertain times, e-learning has never been more important. Our Microbial Solutions portfolio of digital resources is available on-demand to keep your endotoxin testing, microbial detection, and microbial identification education current.

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Articles

USP Chapter 1085: Frequently Asked Questions
Endotoxin Calculations: FAQ Document
Endotoxin Test Methods Comparison Sell Sheet
Putting Endotoxins to the Test
Mechanism of Low Endotoxin Recovery Caused by a Solution Containing a Chelating Agent and a Detergent 
Evaluation of LAL and Recombinant Endotoxin Alternative Assays for an Assessment of Endotoxin Detection Specificity
From the Ocean Floor to Outer Space
Fireflies & Horseshoe Crabs: Innovating Science
Testing the Tests for Contaminated Water


Blogs

Pharma 4.0 
Recombinant Factor C Under the Microscope
The Rapid-Fire World of Endotoxin Testing
Conquering Data Integrity By Eliminating Human Error 
Horseshoe Crab Habitats Extend Further out to Sea Than We Think
Citizen Science With Mystic Aquarium (Video) 
Recombinant Technology for Bacterial Endotoxin Testing: What’s Hot in 2022
Pride of the Sea: A Fisherman’s Role in Patient Safety


Posters

Aspects of Mechanism in Low Endotoxin Recovery 
Utilizing Robotics to Increase LAL Testing Efficiency  


Webinars

What You Need to Know About USP <1085>
Understanding Glucan Impact on Endotoxin Testing
Hints and Tips for Ensuring a Successful LAL Product Validation
Make or Break Your LAL Assay: Choosing the Best Accessories for Your Endotoxin Testing Program
Keeping Quality Control, Bioburden Testing, and New Technologies Current with Annex 1 
Calculating Endotoxin Limits 
Data Integrity: Eliminating Risk & Human Error in Endotoxin Testing
Using Six Sigma Tools for Out of Specification (OOS) Investigations 
Transforming Analytical Data Into Actionable Results
LER: A Biopharmaceutical Operational Reality Perspective
Automating the Microbiology Laboratory: Past, Present, and Future
The Analytical Reality of Recombinant Endotoxin Technologies
Worth the Wait: Navigating the Complexities to Developing a Recombinant LAL
The Journey of the Bacterial Endotoxin Test

Video

Nexus Demo Video
MicroLearning: On-Demand Educational Insights for Bacterial Endotoxin Testing

Articles

How to Select the Right Rapid Microbial Method
Case Study Overview: How to Gain Regulatory Approval for a Rapid Sterility Test 
How Celsis Rapid Detection Systems Provide Operational Benefits to Unilever
Accelerating Development and Release of mRNA-based Therapeutics to Market Using Rapid Methods
Implementation Strategies for Validating Alternative Methods
PDA JPST Article Rapid Sterility Test Systems


Blogs

Pharma in 2021 and Beyond: 7 Trends That Will Drive the Industry 
What can Pharma QC Micro Learn from the Cosmetics Industry?  
Fireflies & Horseshoe Crabs: Innovating Science
Implementing Rapid Sterility Test Systems: A Guide from the Experts 
The Importance of Rapid QC Solutions for Cell and Gene Therapy 
The New Economics of Rapid Microbiological Methods in a Post Pandemic World
How RMMs Mitigate Disruptions to Manufacturing and Operations

 

Webinars

Rapid ATP-Bioluminescence for Non-sterile Product Testing: Roadmap to Implementation  
STAT Results for STAT Samples: Implementing Modern Rapid Micro Methods
The Operational Impact of Celsis® Rapid Micro Methods
Back to Basics: Environmental and Sterility Assurance Control for Medical Devices
Celsis® for Sterility Product Spotlight Webinar
Celsis® For Sterility: Validating a 7-Day Direct Inoculation Sterility Test Using the Celsis Advance 
Think Outside the Box: Applying Rapid Sterility Testing in Biology Quality Control
Keeping Quality Control, Bioburden Testing, and New Technologies Current with Annex 1 

Posters

Rapid Microbial Detection In-Process Biomanufacturing Controls
From Cell Culture to Sterility: Applications for Rapid Detection Across the Entire Biomanufacturing Process
Demonstrating Equivalency and Limit of Detection for a Rapid Sterility Method using ATP-Bioluminescence
Demonstrating Method Suitability for an ATP-bioluminescence Rapid Method for Egg-Based Vaccine Testing

Other Resources

From Cell Culture to Sterility: Applications for Rapid Detection Across the Entire Biomanufacturing Process
Guidance on Implementation of Alternative and Rapid Microbiological Methods Ebook
ARMM Technology Comparison Worksheet
Celsis Advance II™ Virtual Instrument Demonstration
Celsis AMPiScreen® Tested Products Fact Sheet
Accelerating Development and Release of mRNA-based Therapeutics to Market Using Rapid Methods Case Study
Extending Column Resin Life and Reducing Downstream Costs through Rapid Microbial Methods Case Study

Articles

Fagron Sterile Services Relies on Charles River for Critical QC Testing 
Reducing Risk in Your Environmental Monitoring Program
Qualifying Your Cleanroom
Best Practices in the QC Micro Laboratory
Why should you care about Burkholderia cepacia?
Annex 1 Regulatory Changes Increase Expectations for Pharma
Filamenttous Fungi - Facilities Facing Facts

Blogs

Maintaining Quality and Environmental State-Of-Control
Microbiology Core Competencies and Control in the Facility
Annex 1: Regulatory Changes Increase Expectations for Pharma
Microbial ID in Quality Control Microbiology: An Industry Perspective
How Ready Are Your Cleanrooms for Annex 1 Updates?
The Key to Environmental Monitoring
Q&A with Ziva Abraham
Sustainability and Conservation in Microbial ID Labs
Key Takeaways from the FDA’s New Non-sterile Guidance 
New EU GMP Annex 1: The Beginning of a New Era
Introducing AccuPedia™: A Deeper Look into Microorganisms
Next Generation Sequencing for Bacterial Identification

Webinars

Environmental Monitoring and Cleanroom Qualification: What to Expect in the New Annex 1
Keeping Up with Annex 1 Revisions
Back to Basics: Environmental and Sterility Assurance Control for Medical Devices
Microbial Identification: How to Comply with the Current and Future Versions of USP Chapter <797>
A Bacillus cereus Situation: How New Species in the Group Can Affect Manufacturing
Microbial Identification Using A Phylogenetic Approach
Best Practices for Environmental Monitoring and Risk Management
Burkholderia cepacia Complex in the Pharmaceutical Industry
Reducing Manufacturing Risks with Molecular Identification Methods
Understanding the EU GMP Annex 1 Revisions
Tracking and Trending Made Easy
Optimizing MALDI-TOF for Filamentous Fungi Identification
Mold Contamination, Investigation, and Remediation Challenges
Keeping Up With Annex 1 Revisions: Impact of Major Changes
Environmental Monitoring and Cleanroom Qualification: What to Expect in the New Annex 1
CCS Blind Spots: An Exclusive Look at Contamination Investigations

ePosters

Data Integrity in the Microbiology Lab 
How Accurate and Robust is Your Fungal Characterization Strategy?
Comparing Sequence-Based Microbial Identification Methods
Operational Impact of Accurate Microbial Identification within the Burkholderia Cepacia Complex

 

Tools

What is your Microbial ID Program Really Costing You?