PROJECT EXPERTISE

At Endotoxin Consulting Group, the importance of diversity in knowledge specific to endotoxin testing is how we navigate solutions for our clientele. Our team at ECG has strong experience in project management specific in the stage gate process as well as focusing heavily on lean six sigma practices, where we make a collaborative effort to improve performance by systematically removing waste and ultimately reducing variation. 

With this in mind we take all the project management experience with lean principles and evaluate variables such as industry 4.0, automation, data integrity to provide hardware and software solutions with unbias based on your products manufactured required to undergo the endotoxin test for quality control release testing. Our experts have in-depth knowledge of LAL/rFC formulations, complex sample matrices which may exhibit low endotoxin recovery, optical correlations running the gamut from gel-clot testing to automated hardware/robotic platforms utilizing LAL or rFC reagents.  

We offer innovative and smart solutions for all your in-process and final product release testing!

THE ENDOTOXIN TREND

Pharma 4.0 has been called the new industrial revolution, its implementation will more likely resemble an evolution in which digitization and automation meet.
AUTOMATION
Endotoxin Software platforms all adhere to CFR 21 Part 11 compliance, however many have nuances in which some perform better specific to the end-user data integrity requirements .
DATA INTEGRITY
FDA has recently approved the first drug using the recombinant factor C assay for endotoxin testing. As an animal free method this provides a sustainable alternative to LAL-based tests.
rFC
At ECG, we believe strongly in the sustainability of horseshoe crab populations and provide strong guidance when validating utilizing recombinant factor c (rFC) methodologies.
Horseshoe Crab Conservation
The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topicof Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue. At Endotoxin Consulting Group we have experts who can provide analytical and mitigation strategies.
Low Endotoxin Recovery
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