INNO BIO VENTURES SDN BHD

About Inno Bio

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.

Building Competencies in
Biomanufacturing
Inno Bio has
established a strong
platform for
biopharmaceutical
manufacturing
processes.

2004

2006

2007-2010

2011

Facility was
constructed in
Germany
-modular
concept.

Completion of
cGMP facility.

Facility
QualificationIQ,OQ,PQ

Accredited by
National
Pharmaceutical
Control Bureu to
the requirement
of GMP in
accordance to
the current PIC/S
Scheme GMP
guides

Designed in
compliance
with both
EMEA & USFDA

Received
BioNexus
Status

2010
Succesfully
completed 2
contract
manufacturing

Knowledge based high technology company

119 skilled employees
2/3 scientists and engineers

Biopharmaceutical Value Chain

Inno Bio Services
Cell Engineering &
Research Cell Banking

Target
Identification/
Validation

Lead
identification
optimisation

Drug discovery

Manufacturing of clinical grade

materials

Preclinical
Test

Clinical Trials
Drug
Registration

Manufacturin
g of
commercial
products

Commercial
Production

Logistic

Marketing
& Sales

Drug
Development

Preapproval
activities

Approval
activities
-drug registration

Post-approval
activities

Product Development- Commercialisation Activities

Postmarketing
Test

Inno Biologics Services

INNO BIO
OurOFServices
GROUP
COMPANIES

Cell Culture, filtration and

purification development

Pre clinical toxicology & non

GMP material production

PROCESS
DEVELOPMENT &
SCALE UP

CONTRACT
RESEARCH &
TRAINING

GMP facility accredited by

NPCB/PICS

Production capacity at 200L up

to 1000L and has area for
facility expansion

BIO
MANUFACTURING

Cloning & Cell line development

Protein expression
Yield improvement
Humanisation of Antibody

Contract Research & Training

Development of Production Cell Lines
Generate
Antibody

Antibody
Humanisation

Recombinant Protein

Mono/Polyclonal
Antibody

Chimeric or
Humanised

Complex Protein

Support Services
Clone Into Preferred Expression
Vector

Cell Line Engineering: Expression

Vector Design & Development

HT Clone Selection (CPL)

Serum-Free Adaptation

Medium Development

Research/Non-GMP Cell Banking

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

Biomanufacturing
Production of APIs for clinical (human) trial

Upstream Cell Culture Process

Seed 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

Support of Clean Utilities

Qualified utilities system to
support cGMP production

HVAC system
Clean In Place

Reverse Osmosis water

Clean Steam
Water for Injection (WFI)

Quality (QA/QC) Roles in cGMP

Perform various incoming and outgoing
material, product and environmental
tests
Purity, identity, contaminants and
quantification tests

Water analysis
Environmental monitoring
Microbial Testing

Ensure safety, quality and efficacy of

product and overall compliance to
cGMP

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 biosimilar
Erythropoietin (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 clients IND submission.
At the moment, IBL had manufactured biological products intended for clinical trials however
in 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.

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 on
process 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 to
produce biopharmaceutical
products must be based on
mammalian cell culture expression
system in order to fit to InnoBios
existing manufacturing platform

Is
THANK YOU

Inno Bio Ventures Sdn Bhd

Lot 1, Persiaran Negeri BBN
Putra Nilai
71800 Nilai
Negeri Sembilan
www.innobioventures.com