Pharmaceutical Quality Control Scientific Library

Automated growth-based methods have long been utilized to test microbial contamination across a diverse range of pharmaceutical products, including cell and gene therapy (C&GT) products. These innovative therapies are revolutionizing the treatment of life-threatening and chronic diseases, offering significant benefits to patients. Due to their short shelf life, these products must be administered promptly and tested for microbial contamination to ensure patient safety.

Single temperature incubation is less commonly used in environmental monitoring today — but that’s starting to change. This article explores how the right strategy and tools can help your program shift to a single temperature approach for greater efficiency, simplicity, and risk reduction.

For the past 50 years, the Limulus amebocyte lysate (LAL) test has served as the foundation of drug and medical device manufacturing endotoxin control. Now, however, the United States Pharmacopeia (USP) has recognized the need to transition to recombinant methods. 

One of the more advanced technologies, SCANRDI®, can generate accurate results in a little as 4 hours or less. SCANRDI® is a solid-phase cytometry system that applies a highly sensitive, non-growth based rapid microbial method, generating results in 4 hours or less.

Four bioproduction manufacturers evaluted the BIOFIRE^® FILMARRAY^® 2.0 system — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

Two cell therapy and four bioproduction manufacturers evaluted the BIOFIRE® FILMARRAY® 2.0 — interested in the results in an easy-to-digest format? Download a one page Scientific Study Summary that details the study's objectives, outline, and conclusion!

Traditional, manual methods of environmental monitoring can be subject to numeration errors as well as data traceability and integrity issues, which result in overall inefficiency. Want to uncover how automated methods outperform these traditional approaches? Download our infographic now and gain exclusive insights.

There are several leading trends reshaping the compounding pharmacy industry in recent years that we expect to impact the 503B outsourcing facilities in 2024 and beyond.

Embark on a 6-part journey designed to challenge the traditional norms in endotoxin detection.

Matrix-assisted laser desorption ionisation (MALDI) uses a laser to absorb energy from a matrix to create ions with minimal fragmentation from large molecules. It can analyse biopolymers such as DNA, proteins, peptides, carbohydrates, and other organic macromolecules. In MALDI time-of-flight (TOF) mass spectrometry (MS), a TOF analyser measures the mass-to-charge (m/z) ratio of the charged molecules.

The intellectual properties and proprietary methodologies used in making BIOBALL^® redefine what was considered as quantitative microbiology and make it simple to get precise and accurate quantitative microbiological quality controls batch after batch.

Mycoplasma is a genus of gram negative bacilli belonging to the Mollicutes class. Mollicutes include Mycoplasma and Acholeplasma. Mollicutes lack a cell wall and are of very small size (200-300 nm) and have a small genome. Since Mollicutes cannot produce many of the enzymes needed to survive they are parasitic on eukaryotic cells.

Acholeplasma is a genus of gram negative bacilli belonging to the Mollicutes class. Mollicutes include Mycoplasma and Acholeplasma. Mollicutes lack a cell wall and are of very small size (200-300 nm) and have a small genome. Since Mollicutes cannot produce many of the enzymes needed to survive they are parasitic on eukaryotic cells.

Staphylococcus aureus, is a species of Gram-positive spherical bacteria that commonly causes surgical and skin infections, bacteremia (bacteria in the blood) and food poisoning. It’s a ubiquitous microorganism, and can be found on the skin of warm blooded animals.

Candida albicans is an opportunistic pathogenic yeast1 and a common member of human gut flora. It is usually a commensal organism, but it can become pathogenic in immunocompromised individuals under certain conditions.

Aspergillus brasiliensis is a fungus and is one of the most common species of the genus Aspergillus. It is ubiquitous in soil, a common food contaminant, and is also regularly reported from indoor environments such as industrial plants.

Bacillus subtilis is a gram-positive bacteria found in soil and the gastrointestinal tract of ruminants and humans. It is rod-shaped and can form a tough, protective endospore, allowing it to tolerate extreme environmental conditions1.