Determination of Bioburden for Live Biotherapeutic Products

With the help of abundant experience and professional scientists, Creative Biolabs is committed to guiding global customers to a series of bioburden determination solutions. We are always dedicated to assisting our clients with the most satisfactory live biotherapeutic product development services.

Introduction to Bioburden Determination

Bioburden is usually defined as the population of bacteria living on an unsterilized surface. Previous studies have indicated that bioburden is a major threat to human health due to the availability of residues, such as allergens, endotoxins, or exotoxins. Moreover, many reports have revealed that bioburden can affect the stability and effectiveness of live biotherapeutic products. Up to now, two types of bioburden monitoring systems, the destructive system, and the retentive system have been generated and approved for evaluating the microbial contamination in live biotherapeutic samples from different sources. In general, the destructive system is designed to kill microorganisms by using moist and dry-heat sterilization methods. In the retentive system, bioburden monitoring can be achieved by adjusting the parameter settings, including the pore size of the filter, the selected size of microbes.

Bioburden Determination Services for Live Biotherapeutic Products. Fig.1 Bioburden Determination Services for Live Biotherapeutic Products.

Determination of Bioburden for Live Biotherapeutic Products

Bioburden can be associated with biological communities or natural plant communities and can be found in active pharmaceutical ingredients (APIs). Meanwhile, the production process of live biotherapeutic products will have total microbial count limits. As a result, a battery of assays has been developed for performing regular bioburden assessment as a quality control testing in live biotherapeutic products.

Currently, Creative Biolabs has established a panel of assays for providing bioburden determination on a full range of live biotherapeutic products. In our company, we have accomplished a large number of microbial limit testing services based on many medical devices. In particular, all quantitative bioburden determination method has been evaluated by different kinds of samples, and the recovery efficiency of these methods have also been further used for estimating the number of contaminating microorganisms on a medical product.

Our bioburden determination services are composed by detecting the safety of medical devices, the numbers and types of contaminating microorganisms in given live biotherapeutic products. We sterilize the equipment strictly following ISO 11737-1 and operate the microbial limit testing in a designated bioburden laboratory, the Grade D cleanroom (ISO 14644). Furthermore, membrane filtration has been widely used for ensuring the recovery efficiency of bioburden determination assays. Also, the bioburden is calculated by assessing the certain number of units in each of the three batches, which can guarantee data accuracy.

The procedure for Bioburden Determination

  • The validation of a sterilization process
  • Sample extraction from suitable media
  • Filtration of the extraction solution
  • Incubation by using one or multiplex dishes
  • Counting analysis

The live biotherapeutics products have aroused great attention in many clinical settings. To meet the challenging requirements, Creative Biolabs has built a team of experienced scientists with facilities and processes designed specifically to provide the best strategy and protocols customized to bioburden determination services. We have accomplished many projects for detecting the number of viable microorganisms in a range of therapeutic areas. If you have any special needs in our target discovery services or be interested in learning more about our company, please feel free to contact us for more details.

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.


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For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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