Living Biotherapeutic Products (LBP), also known as live bacterial drugs, are active microbial preparations made from normal microorganisms or substances that promote microbial growth. As a new type of drug preparation, LBP has obvious advantages in terms of specificity, targeting, safety, etc., and has a promising application in the treatment of various diseases.
LBPs are different from traditional small molecule drugs or biologics in that they are usually composed of living microorganisms with complex biological properties. Therefore, accurate characterization of LBPs to ensure their stability and consistency during production, storage and use is crucial for patient safety and therapeutic efficacy.
Our Services
The team at Protheragen-ING Lab consists of experts with backgrounds in microbiology, molecular biology and immunology, with in-depth expertise and skills. We use the latest technologies and methods to characterize all aspects of LBP to help our customers ensure the safety, efficacy and consistency of their products.
Live Biotherapeutic Product Characterization Cont.
- Micobiology and Chemistry Testing Services: USP <61> and <82>, Colony and Cram Stain Morphology.
- Appearance, pH, Residual Moisture, Disintegration, Elemental impurities, Organic impurities.
- Raw Materials Testing.
- Environmental Monitoring Program Design - Environmental Monitoring (EM) of cleanrooms used to manufacture microbiome products poses significant challenges. On-site sampling capabilities are available at select locations.
- Robust cold chain storage and stability management capabilities with redundancies in both the -80 ℃ and -20 ℃ the conditions.
Live Biotherapeutic Product Potency Assays
- Drug Product Titering Assays - Confirmation of microorganism titer levels, in an anaerobic incubation environment, is critical for the characterization of Drug Substance and Drug Product sample matrices. Multiple redundant Anaerobe Systems AS-580 chambers/incubators and a state-of-the-art anaerobic gas tank farm are available.
- Viable titer media incubation studies - We work to find the most robust AGAR sources to ensure the complex nutritional needs of anaerobic production strains are met.
- Optimization, validation, and routine testing of LBP Activity assays - Establishment of growth kinetic assays where the production strains are grown in-situ and the level of analyte present post cell culture is measured via HPLC.
- Rapid anaerobic cell enumeration and live/dead cell assays through the Nexcelom Cellometer X2 platform.
Live Biotherapeutic Product Identity Assays
- Confirmation of Defined Drug Product Strain Presence -Utilizing and building client custom genetic and proteomic libraries, Protheragen-ING Lab can create unique solutions to confirm the presence of all applicable production target strains using MicroSEQ 16S Sequencing and MALDI-TOF via the Bruker BioTyper.
- Antibiotic sensitivity profile testing according to CLSI methodology to determine the sensitivity of production strains to a panel of common antibiotics.
Microbiome Characterization Assays
- Antibiotic sensitivity profile testing according to CLSI methodology to determine the sensitivity of production strains to a panel of common antibiotics.
- Freeze thaw chambers for cycle studies between cold chain and ambient temperatures, and traceable cycle automation for stability studies.
- Following cycling, growth-based viable titer and ID assays performed to demonstrate the proportions and identities of the production strains that survived the process.
- For injectable KBPS, a full range of Endotoxin and Purity assessment solutions
- USP <81> Antibiotic Potency testing to identify drug concentrations for traditional antibiotics to be used in conjunction with novel LBP therapies for robust clinical trial execution.
- qPCR analysis for gene presence/absence using multiplex analysis on the Roche LightCycler Instrument platform.
- Disinfectant Efficacy Studies - Custom designed surface coupon evaluations that are based on USP<1072> & AOAC Guidance. Microbiome-specific studies determine disinfectant efficacy on manufacturing surfaces and production microorganisms.
Contact us today to learn more about our LBP representation services or to inquire about customized testing solutions.