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Pharmaceutical Quality Control White Papers

WHITE PAPER

Easy 1 Hour Mycoplasma Detection in Cell Therapy Samples

The BIOFIRE® Mycoplasma solution utilizes the FILMARRAY® 2.0 Industry instrument and a closed pouch PCR test to detect the presence of >130 species of mycoplasma. The system provides sample to answer in ~1 hour with little technical training required. This provides options for bringing mycoplasma testing in-house, thus saving time and outsourcing costs.

WHITE PAPER

Automated 1-Hour Mycoplasma Testing 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

Accurate Identification of Pharmaceutical Environmental Microorganisms

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 may contribute to reduce cost and time linked to investigations and corrective actions.
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.