Foster Jordan, Senior VP, Endotoxin and Microbial Detection, told us microbial contamination is one of the most critical problems in pharmaceutical manufacturing, especially for parenteral products, as microbes thrive in wet areas.
“Microbial contamination in injectable drugs it’s extremely serious – the body has no ability to filter the bacteria through your gut, and severe sepsis can happen,” said Jordan.
“Therefore because it’s so critical it tends to become a burden to the manufacturing process because you’re so concerned about cleanliness it tends to slow everything down.”
The pharmaceutical market for microbiological testing is estimated at $1.4bn. But Jordan said standard QC procedure, which involves pulling samples from different stages of product to analyse in a lab is “extremely inefficient. People are waiting for results and not driving manufacturing. It adds to client costs.”
The Charles River VP said the company is offering portable tests for bacterial endotoxins (the cell walls of gram-negative bacteria), bioburden (viable bacteria – whether gram-negative or -positive), and bacterial identification.
Bacteria endotoxin testing reveals cells that are not viable bacteria but to which the body responds as if they were. “We have Endosafe-PTS, a single-use disposable cartridge. Manufacturers can pull their own water samples at the point of use to ensure they’re endotoxin-free.
“Maybe in the past they would only focus on critical points – ‘go or no go’ – but now they do more frequent monitoring.
“The traditional way of testing pharmaceutical drugs is to pull a certain number of vials from the beginning, middle, and end of the batch to ensure they are microbe-free. But if you produce 500,000 vials and pull 100, you can’t prove the batch is 100% safe. Statistically it’s better to test along the manufacturing process.”
Jordan said he believes a do-it-yourself, factory-based attitude to testing will encourage corrective action prior to a failure.
Once manufacturers identify the presence of endotoxins or bacteria, they can hone in on the type with a third service.
“If you do get a positive, it’s critical you know quickly what type of bacteria it is: gram-negative? Gram positive? Staph? [The] Accugenix [acquisition] comes in there.”
Charles River bought contract testing business Accugenix in 2012, including its bacterial identification libraries. CRL’s service allows users to upload a spectral scan of bacteria to the internet and send it to the library in Delaware for identification.
“We recently expanded that contract service to Asia and Europe through our direct distribution sites,” added Jordan.