Creative Biolabs Offers Comprehensive Analytic Tests to Accelerate Live Biotherapeutic Products Development
New York, USA – March 21, 2022 – Recent progresses in the comprehension of the relationship between microbiota and its host have estimated the therapeutic potential of several microorganisms in disease preventing or treatment. However, safety assessment of live biotherapeutic products (LBPs) remains a real challenge owing to their specific properties and mode of action.
LBPs do not work by reaching distant organs, tissues or receptors, but instead through direct interplay with the complicated native microbiota and/or the modulation of complex host-microbiota relationship, indirectly resulting in almost imperceptible biological effects within the host.
Hence, LBPs developers must carry a thorough risk analysis at an early stage. In order to design suitable development programs for this emerging medicinal product, Creative Biolabs provides a full portfolio of capabilities for the analytical development, functional characterization, and qualification of live biotherapeutic products.
Biological Safety Test for Live Biotherapeutic Products
The safety assessment of live biotherapeutics products must be comprehensive, and should take into account the diversity of microorganisms, health conditions of hosts, the nature of the specific microbe, the possible drug-drug interactions, and so forth. To guarantee the safety of every single probiotic strain and support the live biotherapeutics drug discovery, Creative Biolabs provides featured safety tests for active probiotics, which mainly include active probiotics quantification by CFU counting, in vitro cytotoxicity identification, skin irritation and sensitization test in vitro, ocular corrosion and irritation test, genotoxicity test, etc.
Potency Test for Live Biotherapeutic Products
The potency of live biotherapeutic products is generally a measure of viable cells per unit or dose, i.e., colony-forming units (CFUs), depending on the specific product strains and knowledge of the mechanisms of action. Biological activity or potency is a critical quality attribute; therefore, potency testing is an essential component of quality control for live biotherapeutic products. For live biotherapeutic products that are expected to function, Creative Biolabs can perform potency test for a variety of biologically active molecules with fully customizable design, multiple pathways, reliable results, and fast turnaround time to support both product development and quality control.
Stability Test for Live Biotherapeutic Products
Creative Biolabs provides a host of justified and validated analytical methodologies to determine the stability of live biotherapeutic products. The stability test usually includes method development, method validation, and a stability study. Scientists at Creative Biolabs are adept at conducting accelerated stability studies, short and long-term stability studies for live biotherapeutic products.
Gene Integration Stability Test For Recombinant Strains
A unique aspect of engineered recombinant strain products is the need to ensure gene integration and genetic stability during the production of strains. Creative Biolabs offers a series of molecular and microbial assays that can be applied to evaluate genetic stability of the integration site of an expression construct and can advise on the most appropriate approach for recombinant strain products. The credible genetic stability services of Creative Biolabs include sequencing analysis of the transgene, structure analysis by southern blot, transcript analysis by RT-PCR and northern blot, identity testing for recombinant strains, etc.
Explore more about Creative Biolabs’ capabilities in live biotherapeutic products analytic development at https://live-biotherapeutic.biolabsantibody.com.
About Creative Biolabs
Trusted by scientists all over the world, Creative Biolabs is dedicated to providing a “full-service package” from the microbial identification up to host-microbe interaction tests, and delivering high-quality services that support novel live biotherapeutic products with reliable scientific validation and identification.
Media Contact
Company Name: Creative Biolabs
Contact Person: Candy Swift
Email: Send Email
Phone: 1-631-830-6441
Country: United States
Website: https://live-biotherapeutic.biolabsantibody.com
