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Pharma Quality Control Scientific Library

BIOBALL

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

Over the years, presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the U.S. Burkholderia cepacia is one of the most prominent objectionable microorganism associated with 102 non-sterile drug recalls from 2012 to 2019(1,2). It is an opportunistic pathogen and has a distinctive ability to overcome antimicrobial preservative systems.

MALDI-TOF technology in species-level identification

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Streamlining Pharmaceutical Quality: The Power Of Automated Environmental Monitoring

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.

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Precision matters: Navigating the landscape of quality control in biologics

Humans have been using biologics to treat disease for thousands of years. Unlike chemically derived medicines, biologics are typically very large, complex molecules or mixtures of molecules that are difficult to characterize.

MALDI-TOF technology in species-level identification

SCIENTIFIC LIBRARY

Unleashing potential: tackling CAR-T cell production challenges to support the treatment of blood cancer

As of 2023, CAR-T cell therapy is approved for use in individuals with some types of non-Hodgkin lymphomas, B-cell acute lymphoblastic leukemia, and multiple myeloma. While CAR-T cell therapy has shown remarkable clinical success in treating specific blood cancers, current manufacturing processes have significant room for improvement.

MALDI-TOF technology in species-level identification

SCIENTIFIC LIBRARY

Revolutionize Your Endotoxin Testing

Embark on a 6-part journey designed to challenge the traditional norms in endotoxin detection.
MALDI-TOF technology in species-level identification

SCIENTIFIC LIBRARY

The value of MALDI-TOF technology in species-level identification

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.

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Build Out Your Bioprocess Testing Workflow

Bioprocessing is a type of manufacturing that uses living cells to produce a product. In pharmaceutical bioprocessing, a living cell is manipulated to manufacture the drug of interest in bioreactors and is then purified and formulated to create the end product.

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Why Pharmaceutical Developers Use BIOBALL® 

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.
Microorganism

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Mycoplasma hyorhinis

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.
Microorganism

SCIENTIFIC LIBRARY

Acholeplasma laidlawii

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.

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Prevention and Control of a Staphylococcus aureus Infection

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.
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How Does Pseudomonas aeruginosa Affect the Pharma Industry?

Pseudomonas aeruginosa is a gram negative, rod-shaped bacterium found widely in the environment, such as in soil, water, and plants. They usually do not cause infections in healthy people, but if they do, it is generally mild. It can cause disease in plants and animals, including humans.

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Cutibacterium acnes Gram Positive Bacteria Causing Infection

Cutibacterium acnes (C. acnes) is a Gram positive bacteria that prefers anaerobic (without air) growth conditions1. Cutibacterium acnes can be found on the skin of virtually every human, and it is one of the bacteria that can cause acne.

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Candida albicans

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.

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Aspergillus brasiliensis

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.
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SCIENTIFIC LIBRARY

Bacillus subtilis, how It Affects the Pharma Industry

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.