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Pharmaceutical Quality Control White Papers

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WHITE PAPER

A Rapid, Fully Automated Mycoplasma Detection System

Routine testing for microbial contaminants is a necessary part of ensuring biopharmaceutical product quality and safety. In this white paper, we describe the potential application of BIOFIRE FILMARRAY® – a well-recognized technology used in infectious disease diagnostics for rapid at-line detection of Mycoplasmas in the pharmaceutical industry.
endozyme II go

WHITE PAPER

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? There have been amazing advances in terms of (a) high throughput, (b) error reduction, (c) test organization and (d) value / analyst effort.

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.
Accurate Identification of Environmental Microorganisms

WHITE PAPER

Accurate Identification of 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.

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.

horseshoe crab

WHITE PAPER

Adoption of rFC for Bacterial Endotoxin Testing

Both pharmaceutical companies and regulators have the same goal — ensuring continuous supply of safe drugs and therapies. Global pharmaceutical companies depend upon robust global supply chains to fulfil their endotoxin testing requirements to ensure patient safety. rFC is a safe, sustainable endotoxin testing solution that could mitigate many of the adverse trends impacting global supply chain consistency.
Waste reduction in endotoxin testing infographic

WHITE PAPER

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. Given that Limulus Amoebocyte Lysate (LAL) is packaged in vials (2.6 or 5.2mL) and reconstituted as needed, there is inevitable waste compared to using recombinant Factor C (rFC).