Live Biotherapeutics Developing next-generation probiotics to treat human diseases Tel: 1-631-381-2994
Email: info@creative-biolabs.com
45-1 Ramsey Road, Shirley, NY 11967, USA
CONTENT What is Live Biotherapeutics？
02
The History of Probiotics and Next-generation Probiotics
03
The Potential of Biotherapeutics to Treat Disease
06
Live Biotherapeutics in Clinical Development
07
The Discovery and Development Process of Live Biotherapeutics
08
•
Isolation, cultivation and identification of strains
09
•
Safety evaluation of strains
10
•
Drug efficacy Study
11
•
Mechanism research
12
Creative Biolabs’ Live Biotherapeutics Services
13
Live Biotherapeutics | 01
What is Live Biotherapeutics？
1)
contains live organisms, such as bacteria
2)
is applicable to the prevention, treatment, or cure of a disease or condition of human beings
3)
is not a vaccine
LBPs (live biotherapeutics)=NGPs (Next-generation probiotics)
(Paul W. O‘Toole, et al., 2017)
Live Biotherapeutics | 02
Th History of Probiotics and Next-generation Probiotics
1857-1864 Pasteur discovers LAB as spoilage organisms
1878
1889
LAB isolated from milk by Lister
Bifidobacterium described by Tissier
1990 Bifidobacterium described by Moro
Live Biotherapeutics | 03
1907
1930
Metchnikoff describes Bulgarian Bacillus associated with health
Shirota commercializes fermented milk based on Lactobacillus casei isolate
1953 Kollath uses the term probiotika for active substances promoting health
1965 Lilley and Stillwell define probiotics as microbes that stimulate growth of other microorganisms
Live Biotherapeutics | 04
1989
2001
Fuller defines probiotics as beneficial microbial supplements
FAO/WHO definition of probiotics
2003 Genomic era: first genome sequence of a probiotic, Lactobacillus plantarum
2005
2016
Relman uses highthroughput 16S amplicon sequencing to catalogue gut microbiome.
FDA/CBER guidelines for live biotherapeutics
Live Biotherapeutics | 05
Th Potential of Biotherapeutics to Treat Disease The potential of live biotherapeutics to treat disease Therapeutic areas as % of total pipeline
13%
21% Dermatology Eg. Psoriasis, acne, atopic dermatitis
25% Other Eg. Cancer, CNS, cardiovascular
Endocrinology Eg. Diabetes, obesity
32% Gastro-intestinal Eg. Crohn's disease, IBD, C. diff. infection
8% Genito-urinary Eg. Infection, fertility issues
Live Biotherapeutics | 06
Live Biotherapeutics in Clinical Development Name
Organism
Disease target
Phase
Mutaflor
Escherichia coli Nissle 1917
Irritable bowel syndrome (IBS)
Approved
MIYAIRI 588
Clostridium butyricum
Intestinal disorders
Approved
RBX-2660
Lactobacillus rhamnosus GG
Clostridium difficile infection
Phase 3
IBP-9414
Lactobacillus reuteri
Necrotizing enterocolitis
Phase 3
AG013
Lactococcus lactis
Oral mucositis and cancer
Phase 2
VXM01
Salmonella typhi Ty21a
Progressive glioblastoma
Phase 2
LACTIN-V
Lactobacillus crispatus CTV-05
Bacterial vaginosis
Phase 2
SYNB1891
Escherichia coli Nissle 1917
Hyperammonemia
Phase 2
APS001F
Bifidobacterium longum
Solid tumors
Phase 1
ADXS-HOT
Lysteria monocytogenes
Non-small cell lung cancer
Phase 1
Live Biotherapeutics | 07
The Discovery and Development Process of Live Biotherapeutics
Isolation, cultivation and identification of strains
Safety evaluation of strains
Drug efficacy Study
Mechanism research
Graphical summary of the pathway to regulatory approval for live biotherapeutic products. (Paul W. O‘Toole, et al., 2017)
9 Live Biotherapeutics | 08
Isolation, cultivation and identification of strains Morphological characteristics of Bacteroidetes fragilis. (Humin D, et al., 2016) (a) Colony culture and colony morphology observation. (b) Observations under an optical microscope after Gram-staining. (c) Observations under a scanning electron microscope. (d) Observations under a transmission electron microscope.
Live Biotherapeutics | 09
Safety evaluation of strains
Biological safety test of probiotic Streptococcus macedonicus strains. (Armin T, et al., 2020)
Live Biotherapeutics | 10
Drug efficacy study and mechanism research Akkermansia muciniphila treat the diseases
Effects of A. muciniphila and derived products on host metabolism. (Patrice D. Cani and Willem M. de Vos, 2017) Live Biotherapeutics | 11
Drug efficacy study and mechanism research Clostridium butyricum MIYAIRI 588 (CBM 588) treat the diseases
(Hagihara M, et al., 2020) 13 Live Biotherapeutics | 12
Creative Biolabs’ Live Biotherapeutics Services Analytical Development and Qualification Services for Live Biotherapeutic Products Microbial Identification Potency Test Gene Integration Stability Test Monocyte Activation Test Biological Safety Test Antibiotic Susceptibility/Resistance Test Determination of Bioburden In Vitro Tests of Immune System Modulation Host-Microbe Interaction Tests ……
Live Biotherapeutics Products cGMP Manufacturing Cell bank creating and preserving Microbial fermentation, purification, stabilization, formulation, all the way to packaging, fills, and lyophilization.
Live Biotherapeutics | 13
Tel: 1-631-381-2994 info@creative-biolabs.com 45-1 Ramsey Road, Shirley, NY 11967, USA