ibl company profile and services.pdf

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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