Biocompatibility In Vivo Test for Live Biotherapeutic Products

Creative Biolabs offers a full range of biocompatibility testing services for live biotherapeutic products (LBPs). We take the time to understand the specifics of your demands and we take a cGMP-corresponding approach to designing and implementing your panel of biocompatibility assays.

Importance of Biocompatibility in vivo Test

Conventional approaches to toxicity testing of pharmaceuticals may not be appropriate for biopharmaceuticals due to the unique and diverse structural and biological properties of the latter that may include species specificity and unpredicted pleiotropic activities. In the microbiota field as well, developers have to be innovative in their approach for risk documentation, and therefore safety and toxicity assessment.

The main challenge is the limited relevance and poor predictability of in vivo animal models. Since the microbiome-host symbiosis is highly complex and highly species-dependent. Any difference in the microbiota composition may have substantial consequences on host physiology. This makes that the translation of efficacy and safety signals from animals to humans is extremely difficult, also for most biotherapeutics. So, biocompatibility in vivo test for live biotherapeutic products is necessary.

Fig.1 Brief overview of the steps involved in the translation of newly developed biomaterials from bench side to bedside. (Thrivikraman, 2014)

What We Can Provide?

With extensive expertise in the human probiotic field, Creative Biolabs is committed to providing overall solutions for LBP discovery. We have explored a live biotherapeutics discovery platform for LBP discovery, bioanalysis, and qualification evaluation, and cGMP manufacturing. Biocompatibility in vivo test is a method to investigate LBPs’ safety and efficiency, and has important guiding values for LBPs’ production. Now, we mainly offer blood compatibility analysis and tissue compatibility tests for LBPs.

Our Capabilities

• Characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity, and impurities).
• Purity test of live microbial products (determination of endotoxin content, residual antibiotics, and/or quantification of residual toxic components or contaminants introduced in the manufacturing process).
• Our experts will design tailored biocompatibility in vivo tests to meet your needs and the expectations of the regulatory authorities, as well as being in line with your critical product quality attributes.

Creative Biolabs offers an array for biocompatibility in vivo testing. We work with both large and small animals, and tailor numerous study designs for biocompatibility evaluations. Let our experienced staff help you select or design the right in vivo tests to meet all of your project requirements. If you are interested in our services, please feel free to contact us .

Reference

1. Thrivikraman, G.; et al. In vitro/In vivo assessment and mechanisms of toxicity of bioceramic materials and its wear particulates. Cheminform. 2014, 45(31): 12763-12781.

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