new generation biofactories for a global access to health juan j. infante, phd. bionaturis cso...
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NEW GENERATION BIOFACTORIES FOR A GLOBAL ACCESS TO HEALTH
Juan J. Infante, PhD.BIONATURIS CSO
BIOORGANIC RESEARCH AND SERVICES, S.A.
BIOPHARMACEUTICAL PRODUCTION IN INSECTS
1. Mind the gaps!2. How do we see the future.3. A value proposition.4. Bionaturis manufacturing.5. Bionaturis products.6. Conclusions.
MIND THE GAPS!
DRUGS BIOLOGICALDRUGS
90 %
10 %
80 %
20 %
World Investment population budget use
Intolerable GAP #1: USE OF MEDICINES
+ Tech Transfer
Security/Efficacy/RegulatoryMarket
Licensing-outBiologicalsAPIs/ReagentsDiagnostics
Intolerable GAP #2: TECH TRANSFER
R&I+D
IP
INSTITUTIONS
BIOTECHS
BIG PHARMA
HOW DO WE SEE THE FUTURE?
INSTITUTIONS
BIOTECHS
BIG PHARMA
+ Tech Transfer
Licensing-outBiologicalsAPIs/ReagentsDiagnostics
WHERE THE CHALLENGES ARE?
HERE!
A NEW SCENARIO
20086 corporations with only 10 drugs = 50% of
recombinant proteins market (USD 80 billions)
A NEW SCENARIO
#6
Herceptin (mAb α-HER2R) 4384#7
Aranesp (EPO) 3344#8
Lantus (insulina) 3130
#9
#10
Avastin (mAb α-VEGFR) 4484
Neulasta (GCSF-PEG) 3318
2008 (USD billions)
If we add other 9 corporations, we realize that 15 corporations making “only” 83
drugs take 99% of recombinant proteins market.
G. Steven Burrill, CEO of Burrill & Company (San Francisco, CA)
"As the industry migrates away from an era of the one-size-fits all blockbuster, the biotechnology industry's strength at developing innovative therapies that meet unmet medical needs and target the molecular mechanisms of diseases gives it an upper hand in creating value,"
From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013.
G. Steven Burrill, CEO of Burrill & Company (San Francisco, CA)
“But as pricing pressures become an increasingly challenging prospect for pharmaceutical and biotechnology companies alike, they will need to find new ways to build relationships with payers, providers, and patients to capture value outside of their products"
From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013.
31 dec 09 31 dec 12 31 dec 09 31 dec 120
200
400
600
800
1000
1200
1400
160261
1070
1257
Big BIO vs Big PHARM Capitalization
USD
bill
ions
From “Big Biotech Outpaces Big Pharma”. Biopharm International , Apr 17, 2013.
∆: 57%
∆: 17%
From 15% to 21% in 3 years
A NEW SCENARIO
distribution
manufactur
ing
AVALUE
PROPOSITION
BIOORGANIC RESEARCH AND SERVICES, S.A.
1. What do we do?
CDMO. Development & Manufacturing of Bioactive Agents.
2. For whom?
Pharmaceutical and Veterinary Companies.
3. What´s our goal?
Be an international reference in NICHE DISEASES.
BIOORGANIC RESEARCH AND SERVICES, S.A.
Cabbage looper Trichoplusia niOral infection
Bionaturis headquarters & 400 sq-mt production plant in Jerez de la
Frontera, Cádiz, Spain.
Less investment for more production in a locally sustainable model of protein production.
• 15x decrease in up-front cost.• 10x less space.• Sustain local production.
VALUE PROPOSITION
Flexibility + speed + security + efficacy + SCALABILITY
VALUE PROPOSITION
LARVAE ARE MASS-REARED FOR PEST CONTROL
Industrial production of biological pesticides
Brazil: velvet bean caterpillar, Anticarsia gemmatalis
Embrapa-Soja.
A laboratory for the large-scale production of AgMNPV was opened in 2004 with the intention of being capable of infecting 600,000 larvae per day.
It yields enough virus to treat up to 1.5 million ha/year.
The infected larvae are processed into a wettable powder that involves milling the infected larvae and formulating them into a mixture that contains kaolin.
Baculoviruses were transformed into expression vectors
Disease Brand name(s) Company Active principleVaccines for human use
Cervical cancer Cervarix® GSK L1 protein (VLP)Prostate cancer Provenge® Dendreon PSAInfluenza FluBlok® Protein
Sciences4x HA
Vaccines for veterinary usePCV2 Porcilis® PCV Merck PCV2 ORF2 proteinPCV2 CircoFLEX® B. Ingelheim PCV2 ORF2 proteinClassical Swine Fever Porcilis Pesti® Merck E2 protein
Biological for veterinary useCanine Parvovirus.Feline leukemia virus, Feline Immunodeficiency Virus.
Virbagen Omega®
Virbac Feline interferon Ƴ
FDA/EMA APPROVED BIOLOGICALS MADE IN INSECTS
BIONATURIS MANUFACTURING
BIONATURIS FLYLIFE STAGES OF THE PRODUCTION PROCESS
1. Master Viral DNA
2. Working Viral Bank
3. Manufacturing Viral Seed
4. Upstream Processing
5. Downstream Processing 1
6. Downstream Processing 2
7. Formulation
8. Larvae population rearing
Stages of the production process
CANINE VISCERAL LEISHMANIASIS (BNT005)
1 595 1274
L. Infantum ANTIGEN T. cruzi Hsp70
Animal Health Vaccine Program
Prediction based on data: 3 million doses/day
Entering Leishmania market in Brazil: 200 K doses/year
USD 100/dose
BIONATURIS PRODUCTS
BIONATURIS HDP PROGRAM
Aquatic Health Program
A
B
C
D
BIONATURIS ORAL DELIVERY
Aquatic Health Program
FLYTE strategy
FLYPIDS strategy
Antigen sequence Lipid Droplet Targeting seq.
Antigen sequence Polyproline amphipatic helix
Formulation, method of preparation, and use for delivery to animals or humans. PCT patent application filed March 2012: FORMULATIONS FOR NON-INVASIVE
DELIVERY OF ACTIVE PROTEINS TO AN ANIMAL OR HUMAN. PCT/EP2012/055069.
1.5h 3h
C
G
FP
FT
BIONATURIS ORAL DELIVERY
Aquatic Health Program
TAKE HOME MESSAGES
1. Permanent creativity and innovation in biotechnology and business must lead to a boost in technology transfer.
2. Bionaturis proposal based on insect larvae biofactories is effectively adding value to active principles for niche diseases and promoting more access to health.
THANKS FOR YOUR ATTENTION!Juan J. Infante, PhD.
Bionaturis Chief Scientific Officer.
www.bionaturis.com