Creative Biolabs provides an integrated microbial analysis solution spanning the full life cycle of LBPs—from strain characterization to formulation stability assessment.
SHIRLEY, NY, June 11, 2025 /24-7PressRelease/ — The establishment of standardized analytical frameworks for safety, efficacy, and product consistency is becoming a critical component in microbiome-based drug development. Leveraging years of experience in microbial research, Creative Biolabs has launched an advanced microbial service platform designed to offer a more standardized and controllable technical pathway from strain screening to product finalization.
“Many projects get stuck at the IND, and we found out for a good reason, unbelievable amounts of repetitive studies without a proper structured analytical strategy,” claimed an expert of the analytical team at Creative Biolabs. “This greatly increases time delays as well as expenses prior to clinical testing.”
The company’s platform integrates several critical elements of LBP development. These include strain identification, contaminant analysis, formulation development, viability monitoring, and stability evaluation—addressing several common bottlenecks in LBP development:
Strain Characterization
Different microbial sources often lead to different strains with varying details of functional capabilities. For strain validation, Creative Biolabs uses advanced 16S rRNA sequencing, MALDI-TOF mass spectrometry, and whole genome sequencing techniques to evaluate immunomodulatory effects, adhesion potential, or antimicrobial actions of candidate strains—this opens doors to downstream efficacy research.
Contaminant Detection and Purity Assessment
Unlike chemical drugs, live microbial formulations are inherently vulnerable to contamination. Continuous batch-to-batch purity verification is essential. The platform includes screening for aerobic/anaerobic bacteria, yeast, and molds, supported by CFU enumeration, qPCR, and digital PCR for strain-specific monitoring.
Formulation Science and Stability Studies
Development of biosimilar products with respect to formulation: the microbial impact during storage and delivery needs to be controlled. Creative Biolabs aids in generating quality data that could form the basis for an IND or NDA submission by assisting in cryoprotectant screening, enteric coat evaluation for capsules, and performing real-time or accelerated stability testing.
In addition to its analytical services, Creative Biolabs has also built a portfolio of probiotic reference materials. “Our portfolio includes DNA standards, quality control (QC) strains, and engineered expression strains—all designed to support methodological validation and testing reproducibility,” the expert noted.
Of particular interest is the company’s collection of probiotic strain products tailored for live probiotic research and industrial applications. These strains support the engineering and recombinant expression of bioactive factors—such as antimicrobial peptides or immunomodulatory proteins—directly within probiotic hosts.
Industry experts widely agree that the scientific advancement of LBPs depends on the deep integration of biology and analytics—not merely on the combination of strain selection and formulation development. Platforms built on this principle may offer greater predictability and control for the future of this emerging therapeutic class.
For more information about Creative Biolabs’ LBP services, please visit https://live-biotherapeutic.creative-biolabs.com/.
About
Through its integrated platforms, Creative Biolabs aims to accelerate the development of next-generation microbiome-based therapies and to support clients worldwide in navigating the complex path from concept to preclinical development.
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