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 5-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.

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.

Unlike our counterparts in the chemical world, consistently precise and accurate results from pharmaceutical microorganism quality control are encountered less often. In other words, quantitative microbiological testing allows for fairly large discrepancies in the results due to the inherent difficulties in dealing with living organisms as well as quantifying them.

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.

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.

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.

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.