FOCUS
The Endotoxin Consulting Group (ECG) is a global microbiology consulting firm focused specifically on the bacterial endotoxin test utilizing Limulus Amebocyte Lysate (LAL), performed in the United States under USP <85>,the European and the Japanese Pharmacopeia. We also strongly believe in the sustainability of horseshoe crabs and provide strong guidance when validating utilizing recombinant factor C (rFC) methodologies.
Our services range from short to long term laboratory start-up in addition to validating complex samples types with guidance on endotoxin masking in biologics commonly referred to low endotoxin recovery (LER). Our expertise lies with knowledge of all reagents, hardware and software technologies provided by all LAL/rFC manufacturers. We offer guidance and focus on new technologies to validate first time right with intense focus on data integrity.
Our ultimate aim to protect end-users performing the endotoxin test by offering a conscientious view of all options available with respect to horseshoe crab conservation.
Laboratory Start-Up
Expertise on best methods, hardware, software and LAL/rFC Reagents needed. We recognize the need for low sensitivities/sample treatments to overcome potential interference.
Validation & Documentation
We offer guidance on development of standard operating procedures on all aspects of the endotoxin test specifically with your sample in mind.
On-Site Training & Troubleshooting
We offer short and long term on-site assistance with full training classes with certification. Our goal is make offer peace of mind once a process has been validated with full support a continual basis.
FDA Mock Audits and Representation
We off full support during a FDA audit and will also perfom mock audits specifically on your endotoxin testing process to ensure all processes are providing accurate data. Meta-Data is examined under scrutiny.
Automation with Data Integrity
At ECG we have leading consultants who are experts on data integrity, best in class endotoxin software and automation offerings to reduce errors in your overall process to quicker results, with time and money saved as a result . The importance of these aspects can significantly affect your success rate when bringing new products to market.
About
With over 25 years experience in the LAL arena, our experts are ready to help your lab take the next step. Learn more about who we are.
Take Action
Protecting consumers from bacterial contamination is of utmost importance as necessary quality control method under USP <85>.