ibl company profile and services.pdf
TRANSCRIPT
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INNO BIO VENTURES SDN BHD
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About Inno Bio
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Inno Bio Ventures Sdn Bhd
Cornerstone investment by Government
as part of National Biotech Policy.
Operational in 2006 & acquired cGMP in
2011.
Located in Nilai, Negeri Sembilan,
Malaysia.
Ministry of Finance Incorporated
Company and has close affiliation with
Ministry of Science, Technology and
Innovation.
Inno Biologics Sdn Bhd- Subsidiary
Facility: Mammalian Cell Culture:1000L Bioreactor.
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Building Competencies in
Biomanufacturing
2004
Facility wasconstructed in
Germany
-modular
concept.
Designed in
compliance
with both
EMEA & USFDA
2006
Completion ofcGMP facility.
Received
BioNexus
Status
2007-2010
FacilityQualification-
IQ,OQ,PQ
2010Succesfully
completed 2
contract
manufacturing
Inno Bio has
established a strong
platform for
biopharmaceutical
manufacturing
processes.
2011
Accredited byNational
Pharmaceutical
Control Bureu to
the requirement
of GMP in
accordance to
the current PIC/S
Scheme GMPguides
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Knowledge based high technology company
119 skilled employees
2/3 scientists and engineers
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Biopharmaceutical Value Chain
Target
Identification/
Validation
Lead
identification
optimisation
Preapproval
activities
Preclinical
TestCommercial
ProductionLogistic
Marketing
& Sales
Post-
marketing
Test
Approval
activities-drug registration
Post-approval
activities
Drug discoveryDrug
Development
Clinical Trials
Drug
Registration
Manufacturing of clinical grade
materials
Manufacturin
g of
commercial
products
Cell Engineering &
Research Cell Banking
Product Development- Commercialisation Activities
Inno Bio Services
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Inno Biologics Services
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PROCESS
DEVELOPMENT &
SCALE UP
BIO
MANUFACTURING
CONTRACT
RESEARCH &TRAINING
Protein expression
Cloning & Cell line development
Pre clinical toxicology & nonGMP material production
Cell Culture, filtration and
purification development
Yield improvement
GMP facility accredited by
NPCB/PICS
Production capacity at 200L upto 1000L and has area for
facility expansion
INNO BIO
GROUP OF COMPANIESOur Services
Humanisation of Antibody
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Contract Research & Training
Development of Production Cell Lines
Support Services
Generate
Antibody
Clone Into Preferred Expression
Vector
Antibody
Humanisation
HT Clone Selection (CPL)
Recombinant Protein
Mono/Polyclonal
Antibody
Chimeric or
Humanised
Complex Protein
Cell Line Engineering: Expression
Vector Design & Development
Serum-Free Adaptation
Medium Development Research/Non-GMP Cell Banking
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Process Development & Scale-up
Process Verification and Technology
Transfer
Verification (at small scale and pilot scale) of
optimised process for establishing critical
information for GMP manufacturing operation
Process Scale-Up
Scale-up of optimised process and robustness
study
Pre-clinical Material Production for
Animal Study
Rapid development of processes for
production of toxicology material
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Biomanufacturing
Production of APIs for clinical (human) trial
Upstream Cell Culture ProcessSeed culture spinner/ shake flask 20ml 2L
Seed bioreactors 5L, 30L, 200L (Sartorius)
Production bioreactors - 200L and 1000L
(Sartorius)
Downstream Processing
Cell clarification POD Depth Filter (Millipore),
Microfiltration (Sartorius)
UF/DF System - Uniflux (GE), Sartoflow (Sartorius)
Chromatography AKTA Process 10, 6mm (GE)
Support Operation
Cell banking including WCB and MCB
Media and buffer preparation - 300 to 1000L
process tank
Disposable mixing system
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Support of Clean Utilities
Qualified utilities system tosupport cGMP production
HVAC system
Clean In Place
Reverse Osmosis water
Clean Steam
Water for Injection (WFI)
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Quality (QA/QC) Roles in cGMP
Perform various incoming and outgoing
material, product and environmentaltests
Purity, identity, contaminants and
quantification tests
Water analysis
Environmental monitoring
Microbial Testing
Ensure safety, quality and efficacy of
product and overall compliance to
cGMP
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Manufacturing Experiences
As a CMO, IBL focuses on manufacturing products intended for clinical trials. In 2010, IBL had
successfully manufactured and delivered few batches of second generation biosimilarErythropoietin (EPO) for an international client. IBL had been able to obtain a comparable
process and product quality with slightly higher product yield by using the existing IBL
platform technology. The biosimilar product is undergoing Phase I trial in India.
Following that, IBL was given a contract to produce one novel monoclonal antibody for the
treatment in immunology area in which IBL had completed the project and delivered the
product to the Korean client in 2011. The monoclonal antibody was used in Phase I clinical
trial in Korea. Another project is the production of novel monoclonal antibody which is
intended for Phase II clinical trial for the treatment of brain tumors. This Korean project will
be completed in Quarter 4, 2014. Throughout all projects, IBL had provided full support and
documentations required for the clientsIND submission.
At the moment, IBL had manufactured biological products intended for clinical trials howeverin short term IBL is set to gear up towards commercial manufacturing through facility
expansion plan of having secondary production train and fill and finish facility to increase
capacity and support the market demand.
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Criteria of companies to match with
InnoBio
Criteria of companies/ institutions Spin-off companies
Small and medium sized R&D biopharmaceutical companies
Research institutions
* The target companies may already have their research stage of
biopharmaceutical products completed, and ready to embark onprocess scale-up and drug production for pre-clinical and clinical studies.
However in this case, they may lack the cGMP manufacturing facilities to
produce the drug. InnoBio is glad to provide the manufacturing services
to these companies.
Platform technology used toproduce biopharmaceutical
products must be based on
mammalian cell culture expression
system in order to fit to InnoBios
existing manufacturing platform
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Is
THANK YOU
Inno Bio Ventures Sdn Bhd
Lot 1, Persiaran Negeri BBN
Putra Nilai
71800 NilaiNegeri Sembilan
www.innobioventures.com