White Papers

State Of The Art Automation For Endotoxin Testing

They say “A rising tide lifts all boats” and this is true for advances in automation as applied to various analytical test methods. Have you checked the state of automation capabilities recently? Read the white paper to learn more.

Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This white paper discusses the challenges of one media/one temperature incubation, with a real case study and evaluates the sustainability of a single incubation temperature strategy for Environmental Monitoring.

Environmental Monitoring for Pharmaceuticals

In microbiology and pharmaceutical development, environmental monitoring (EM) is a process that determines the quality of a controlled environment via microbial data collection.

Easy 1 Hour Mycoplasma Detection in Cell Therapy Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

BIOBALL® Burkholderia cepacia Complex Strains Performance Testing for USP <60> Growth Promotion Requirements

This white paper provides an evaluation of BIOBALL® MultiShot 550 Bcc range recovery levels on bioMérieux BCSA (Ref 33631) ensuring they are acceptable as per growth promotion and indicative properties testing requirements of USP <60> chapter.

Bacterial Endotoxin Testing: 10 Reasons to Choose Recombinant Factor C

Recombinant horseshoe crab Factor C (rFC) methods are the latest state-of-the-art solution for effective bacterial endotoxin testing (BET). This whitepaper reviews the advantages of Recombinant horseshoe crab Factor C (rFC) over the BET methods currently in widespread use. We compare the performance of LAL reagents with rFC, and summarize the evidence supporting our 10 reasons to choose rFC.

How Drug Developers Use a Feasibility Study to Protect Their Investment

A feasibility study is probably the single most important consideration when it comes to changing your method of application. One will quickly confirm your product compatibility and method. bioMérieux provides high-quality products and applies these exact standards to our feasibility studies.

Waste in Endotoxin Detection Assays LAL vs rFC

From traditional to alternate endotoxin testing methods used for product release testing, there is an opportunity to waste less reagent and generate cost savings.

EM Data Quality Management

Drug developers rely on data quality management (DQM) during development and manufacturing for a number of reasons and, therefore, must start with a clear data management strategy in order to organize and protect the integrity of the products, along with the safety and well-being of patients.

Detection of Small Events Environmental Monitoring Culture Media

USP chapter <1116> describes Environmental Monitoring (EM) as a key element to ensure control of aseptic processing areas. The quality of the drugs manufactured is directly linked to the capacity to minimize microbial contamination.

Single Temperature Analysis for Environmental Monitoring Samples

ENVIRONMENTAL MONITORING (EM) is one of the main microbiological controls that pharmaceutical industries perform to ensure the safety and efficacy of pharmaceutical products. To efficiently control the quality of these products, the presence of potential microbial contaminants must be monitored. Although the traditional method is extremely manual, variable and error-prone, it remains the standard procedure used in industry for hundreds of millions of samples per year.

Adoption of rFC for bacterial endotoxin testing

With industry’s push to build a more diverse global supply chain, we find ourselves at a tipping point for the widespread adoption of alternative solutions like rFC — driven as much by industry, if not more, than regulators.

Automated nucleic acid amplification assay for mycoplasma detection in cell and gene therapy products

Cell & Gene therapies (CGT) or advanced therapeutic medicinal products (ATMPs) are innovative medicines developed to treat cancers, rare diseases, autoimmune disorders and injuries. As these therapies utilise living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

Non-Growth-Based Alternative Sterility Testing

The SCANRDI® is a non-growth-based rapid microbial method (RMM) that detects not only viable microbial cells that can be isolated using a broth or agar plate but also viable but non-culturable (VBNC) microorganisms, including stressed and fastidious microorganisms that may not be recovered by standard culture methods, making SCANRDI® more sensitive than growth-based methods.

Overcoming Mycoplasma Testing Challenges in Cell and gene Therapy Manufacturing with BIOFIRE®

The BIOFIRE® Mycoplasma test is a closed-system sample-to-answer nucleic acid test that is designed to report the presence/absence of over 130 mycoplasma species in less than an hour. It requires minimal hands-on time and contains everything needed to run a molecular test in a sealed pouch.

Automated 1 Hour Mycoplasma Detection in Bioproduction

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells.

Sustainable Glass Packaging and Test Reagent Use Practices that Significantly Reduce Waste

Nine out of 10 top global pharmaceutical companies have set targets to reduce their carbon footprint. One of the main driving forces behind the pharmaceutical industry’s efforts to reduce its carbon footprint is the rapidly changing regulatory environment following the Paris Agreement, ratified by 196 countries in 2015.

Endotoxin Testing: New Horizons with Recombinant Reagents

A comprehensive analysis of historical context, current practices, and future directions in Europe and the United States.

Harnessing the Power of CAR-T Cell Therapies Without Compromising Quality Control

Download the white paper to learn about CAR-T cell therapy, which uses a patient’s own genetically modified T cells to target and kill cancer cells.

The Hunt for the Missing Endotoxin

This white paper explores the causes and impact of low endotoxin recovery (LER) and presents solutions, including guidance on in-house protocol development, outsourcing considerations, and the use of the ENDO-RS® de-masking tool kit. It also features expert insights from Dr. Christian Faderl on how pharmaceutical manufacturers can effectively address masked endotoxins.

Validation Protocol

In the Pharmaceutical industry, Validation protocol and/or Qualification protocol list a set of procedures (tests to be performed) used to check if a product meets the proper requirements of its intended purpose.

New Standardized Methodology to Evaluate Environmental Monitoring Plates Inspection Using an Automated System

To efficiently control the quality of pharmaceutical products, manufacturers must monitor for potential microbial contaminants. This is typically performed using irradiated culture media in Petri plates throughout the production process, especially within clean rooms, isolators and controlled production environments.

Image Whitepaper - Accurate Identification of Pharmaceutical Environmental Microorganisms

Accurate Identification of Pharmaceutical Environmental Microorganisms Using VITEK® MS

Microbial contamination of pharmaceuticals poses a great problem to the pharmaceutical manufacturing process from both a safety as well as an economic point of view. Rapid and accurate identification of microorganisms can contribute to reduce cost and time linked to investigations and corrective actions.

Image Whitepaper - APR Whitepaper_Automated Methods for Environmental Control (EM)

A Recognized Rapid Microbiological Method for Cell & Gene Therapy Products: Regulation & Industrial Application

This white paper details how innovative microbiological technologies are revolutionizing sterility testing for Cell and Gene therapy products. You'll learn the validation guidelines for alternative microbiological methods and gain understanding of the regulatory evolution and acceptance of rapid microbial testing.

Automated Methods for Environmental Control (EM) - Application of Automated Microbiology for Environmental Monitoring of Clean Rooms

Optimizing the control of bioproduction processes and the environmental monitoring of the biopharmaceutical industry is key to supporting the competitiveness of companies and no longer making quality control a bottleneck in the value chain of bioproduction but rather a real added value.

Low Endotoxin Recovery: A Mitigation Approach Case Study

This white paper discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference. Authors Dr Christian Faderl and Kevin L. Williams detail the steps for conducting a demasking study and walk through the process, providing a comprehensive case study.

Role of in-house isolates in pharmaceutical quality control

Download this application note by Dr Megha Bajaj, Global Solution Manager at bioMerieux, to discover more about: - The relevancy of in-house isolates in microbiological QC testing - The selection and implementation of in-house isolates - Common microorganisms isolated in pharma labs.