Biotherapeutics production

1 October 2021

Recounts of a Venture Cup winner

Bacterial therapeutics as a new natural cure for  diseases

Recounts of a Venture Cup winner

Bacterial therapy is the therapeutic use of bacteria to treat diseases. Bacterial therapeutics are living medicines and maybe wild-type bacteria (often in the form of probiotics) or bacteria that have been genetically engineered to possess therapeutic properties when injected into a patient.

The development of Live Biotherapeutics products (LBPs) is an extremely active research area in the fields of synthetic biology and microbiology. Biotherapeutic medicines are unique. Biotherapeutic medicines are made using living systems, which are more sensitive to change than the straightforward chemical synthesis process commonly used for small molecule drugs. The final product is therefore determined by a wide range of factors, which include the actual manufacturing process. Small changes in manufacturing can alter the final product, as biotherapeutic medicines are composed of larger and more complex molecules which are difficult to characterize. The high complexity of this process requires precision, conformance to good manufacturing practices, and defined specifications in order to maintain the safety and efficacy of the product over time. Approximately 250 in-process tests are carried out for a biotherapeutic medicine, compared to around the 50 done for a chemically synthesized small molecule drug.

When it comes to bacterial total viable counts (TVC), most of the traditional tests and methods available on the market are slow, inaccurate, and costly. They are mainly conducted in centralized labs, instead of being available close to the production line.  But recently, a novel solution for rapid TVCs has been introduced by SBT instruments, namely a portable device, that can be placed everywhere in the production line, the only thing you need is a power socket.

Our device, the BactoBox®, can be used to give a here and now answer on the total concentration of bacteria in a sample. This allows users to control bacteria growing processes to optimize the outcome product yield and quality.

The development of novel live biotherapeutics products requires bacterial test suspensions with reliable concentrations. BactoBox can provide this answer immediately with no need for calibration curves so you can move swiftly to the actual experiment and speed up your production processes.

BactoBox is very easy to use, requires practically no training to operate – press the button and get results. It counts all bacteria including anaerobic bacteria and bacteria that are difficult to culture on plates. BactoBox has a small footprint and fits in most places, is user-friendly, and delivers accurate total bacteria counts in just 2 minutes.

The BactoBox® is available for the trials. Spend 2 minutes of your time to fill the request form on our website and test the device for your specific application.

Link to the request form

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2730 Herlev