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DISRUPTING
THE DRUG DISCOVERY
LIFECYCLE
DRUG DISCOVERY IS A LONG CYCLE
ALMOST UNCHANGED FOR THE
LAST 50 YEARS
DISCOVERY PROCESS
Laboratory – design, biotech
Upscaling (GMP)
Testing (in vitro, in situ, non clinical, clinical)
Laboratory – design, biotech
Upscaling (GMP)
Testing (in vitro, in situ, non clinical, clinical)
LABORATORY
1. SYNTHESIS – TEST FOR ACTIVITY
2. TARGETED DRUG DISCOVERY
3. BIOTECHNOLOGY
1 – RAISING COSTS / FINANCIAL
CAPABILITY
80s-90s
MACROMOLECULAR CRYSTALLOGRAPHY
ALLOWED
RECEPTOR IDENTIFICATION
CELLS PRODUCE WHAT WE INTEND
EXTRACTION / PURIFICATION
(20-30,000 Da – 2-300,000 Da)
Laboratory – design, biotech
Upscaling (GMP)
Testing (in vitro, in situ, non clinical, clinical)
500-700 Kg protein
USD 1 bn, 25,000L, very large
area
USD 450 million, 15-20,000L,
large area
2010
2013
very large and expensive (USD 1 bn) production facility to supply the
global market
Old paradigm
Centralized manufacturing for development economies (e.g. USA,
EU, Japan)
500-700 Kg protein
USD 25 million, 2-2,500L,
7,000m2
2015
Process
Development
Quality Control
Administration
Upstream
Warehouse/
Dispense
Utilities + 6F & Roof
Downstream
| Centre of Excellence
500-700 Kg protein
USD 2-5 million, continuous or
50-200L, 3-5 m2
2017-8
New paradigm Distributed manufacturing for local markets
(e.g. Africa, Asia, Latin America)
No large storage tanks No large filtration equipment No large chromatography column, no
large TFF system No large pumps
Single use process
Media Preparation
INTEGRATION INTO A CONTINUOUS PROCESS
ALL IN ONE
Viral Clearence
Capturing Concentration Cell
harvest Culture
Smaller Equipment
Smaller Footprint
Reduction of utilities
comsumption
Simplified operations
Reduced OPEX
& CAPEX
- Proprietary systems -
New paradigm
1
3
2
CAPEX
intensive
Prohibitive
OPERATIONAL
COSTS
Lack of KNOW
HOW
AFFORDABLE
facility
RE- INVENT
manufacturing
strategy
Consortium for
GLOBAL SUPPORT
in project management
CoGS
50 kg / 5 m doses 500 kg / 50 m doses
Investment
USD m ] [
Production capacity / year
≈
200
20
Stainless Steel facility
SINGULARIS FACILITY
PRICE OF PROTEIN
Eur 30,000/g
to Eur 1,000/g and even less
PRODUCTIVITY
Less than 1g/L – 7g/L
Formulation / analytics
Upscaling (GMP)
Testing (in vitro, in situ, non clinical, clinical)
MODELS
• Models to measure a specific
response
• Reproducible, reliable
BIOSIMILARITY
• Finger-print like similarity
• Analytical data sufficient
• CPMP/EWP/4151/00 REV 1:
• „...ONLY COMPARATIVE IN VITRO DATA,
• OBTAINED WITH AN ACCEPTED METHOD MAY BE
CONSIDERED ACCEPTABLE
• IF THE PRODUCT SATISFIES ALL OF THE
FOLLOWING 9 CRITERIA
RESPIRATORY MODEL
REGISTRATION PATH …
8. The inhalation device has the same resistance to airflow (within+/-15%)
6
0 5
E 4
2
app I i cants in haler
2 Seretaide inalador
a
0
0 2 0 3 0 4 0 5 0 6 0 7 0 2 0 9 0 1 0 0 1 1 0
Caudal [Lim in]
9. The delivered dose is the same (within +/- 15% of labelled claim)
Nível1 (P,O) Nível2 11,21 Leven. Nível4
OAS l 6,7;0
Ltve 1 (P,O) Le ve 2 (1,2) Level Level 4 (5,4,5)
Salmeterol / 50 lig
Flow rate 60 L/min
0
SOO •
Mea
n m
ass
[R,g
]
400 •
300 •
200 •
100 •
Fluticasone propionate
Flow rate 60 L/min 2
I n
C ra
2
200
0
120
0
160
0
140
0
120
0
100
0
SOO
SOO
400
200
0
· 4—Mean mass rug] Reference product (R) —0—Mean mass (lag] Reference product lR)
· 0—Mean mass (pgj Reference product (A) —a—Mean mass (pg] Reference produtct (A)
WOUND MODEL (burns, cuts, diabetic
foot, post-surgery)
IN VITRO - no standard test
ANIMAL- ethical concerns
HUMAN – ethical concerns
How to measure
wound healing?
WOUND HEALING
Diameter
Doctor’s eye Blood flow
COMPARING COST EFFICACY OF
DIFFERENT TREATMENTS
INFRARED
DATA TREATMENT
TWO CRITICAL CONDITIONS
1 – VALIDATION OF DATA
REPRODUCIBILITY
2 – REGULATORY APPROVAL
COMMERCIALIZATION
Highly regulated industry
Paper industry
Medical devices
3m-3 years
Pharmaceutical
6m-7 years
Biolotus Biotech
Av Evandro Lins e Silva 840, Sl 319
Barra da Tijuca, 22631-470
Rio de Janeiro
Brazil
Tel +5521-24802405, -30793451, -982069998
www.biolotus.com