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Pharma Quality Control White Papers  

Detection of Small Events in Environmental Monitoring Culture Media

WHITE PAPER

Part I : Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This whitepaper discusses the challenges of one media / one temperature incubation, and evaluates the sustainability of a single incubation temperature for Environmental Monitoring.

Detection of Small Events in Environmental Monitoring Culture Media

WHITE PAPER

Part II : Suitability of a Single Incubation Temperature for Environmental Monitoring Programs

This white paper presents the results and explains the methodology used at Sanofi (Marcy l’Étoile Site - France) to evaluate the suitability of a single incubation temperature for Environmental Monitoring.

It 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.

Detection of Small Events in Environmental Monitoring Culture Media

WHITE PAPER

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

Cell & Gene Therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat diseases such as cancer, rare diseases, and autoimmune disorders.

Those therapies, based on living cells, have short shelf lives, are available in low volumes and cannot be sterilized by filtration or irradiation. Microbiological examination of cell-based products is critical to ensure safety prior to patient infusion.

Detection of Small Events in Environmental Monitoring Culture Media

WHITE PAPER

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.

Detection of Small Events in Environmental Monitoring Culture Media

WHITE PAPER

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.

Detection of Small Events in Environmental Monitoring Culture Media

WHITE PAPER

Detection of Small Events in Environmental Monitoring Culture Media

Automated Incubation and Reading versus Visual Inspection

USP chapter <1116>1 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. 

WHITE PAPER

ENDOZYME® II GO automation solution for endotoxin testing

The Tecan Fluent® workstation has been paired with the bioMérieux ENDOZYME® II GO pre-coated plates to create a seamless automation solution for endotoxin testing.

BIOFIRE Mycoplasma

WHITE PAPER

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).
Mycosplasma white paper

WHITE PAPER

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 (1).

WHITE PAPER

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.

WHITE PAPER

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.

WHITE PAPER

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.

WHITE PAPER

The Hunt for the Missing Endotoxin

This white paper reviews the causes contributing to low endotoxin recovery (LER), the impact it creates, as well as solutions which can rectify the issues it results in. We also discuss the advantages and disadvantages of developing your de-masking protocols in-house, and how you can use the ENDO-RS® de-masking tool kit to make the process easier from beginning to end. Following this, we outline the pros and cons of outsourcing your de-masking project, what you should look for in a third-party company, and why you can and should trust bioMérieux with your de-masking protocol development.

WHITE PAPER

Bacterial Endotoxin Testing

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.

WHITE PAPER

Qualification and Method Validation in the Pharmaceutical Industry

The pharmaceutical industry is highly regulated in a number of ways. One of them is Qualification and Validation. But what are we talking about? Why do we talk about Qualification AND Validation? What does this apply to? What tools accompany these approaches? How are they deployed?

WHITE PAPER

How Drug Developers Use a Feasibility Study to Protect Their Investment

Pharmaceutical manufacturers use feasibility studies to ensure the solution they would implement (equipment, system, process…) meet their expectations in compliance with highest standards.

WHITE PAPER

What is driving the adoption of rFC for bacterial endotoxin testing?

As industry leaders seek strategies to build supply chain resilience, multi-sourcing is driving the adoption of alternative solutions like rFC.

WHITE PAPER

Waste reduction in endotoxin testing

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