Lsl Bio Pharm Linkedin 04 09a
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Lsl Bio Pharm Linkedin 04 09a

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    Lsl Bio Pharm Linkedin 04 09a Lsl Bio Pharm Linkedin 04 09a Presentation Transcript

    • Biopharmaceutical Division Overview
    • Life Scientific Ltd.
      • Contract Development Organisation that has assisted, since its foundation in 1995, the development , validation and regulatory requirements of the following industries:
      • Biopharmaceutical
      • Pharmaceutical
      • Plant Protection/Agri
    • About Us
      • Why entrust Life Scientific with key study needs :
        • Privately owned, organically grown customer-focused CRO
        • ~15 years experience in outsourcing industry
        • >75% of business is from either referrals or return clients
      • GLP and GMP certified Laboratory Facilities:
        • Bio : NovaUCD, Belfield Innovation Park, UCD
        • Agri/Pharma : Blackrock, Co. Dublin
      • Staff : Backgrounds from across drug development industry including:
        • Biopharmaceutical (Immunotherapy)
        • Diagnostics (Biomarkers, Infectious Disease)
        • Other CROs (Bioanalytical)
        • Pharmaceutical
    • Biopharmaceutical Division
      • Core expertise : development, validation and utilisation of proteomic, immuno and cell-based methodologies for the analysis of:
      • Biopharmaceuticals
      • Biomarkers
      Biopharmaceutical Division
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration We are experts in the development and validation of customised immuno, proteomic and cell-based methods for evaluation of: Biomarkers Biopharmaceuticals Biopharmaceutical related factors (anti-drug antibodies, neutralising antibodies, process and product related impurities etc.) Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration
      • Our customised immunoassay methods will ensure accurate, precise and sensitive detection of:
      • Drug
      • Anti-Drug Antibodies (IgG, IgM, IgA etc.)
      • Biomarkers of efficacy/toxicity/safety/response
      Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Life Scientific can assist your biomarker and diagnostic requirements, be they focused on analysis of probable or known valid biomarkers, surrogate endpoints, fit-for-purpose analyses, analytical validation or clinical validation. Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration
      • Services include
      • Method and Product Design, Development and Validation
      • Immunoassay Probe Design for maximisation of
              • - Clinical sensitivity and specificity
        • - Translational/bridging/cross species capability
      • Analytical and Clinical Validation
      • Project Management
      • On site/multi-site validation for intra-and inter-laboratory reproducibility
      Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Read Biomarkers in Drug Development in the February 2007 issue of Pharma Magazine http://www.nxtbook.com/dal/viamedia/pharmadigitalfeb2007/index.php Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration
      • Life Scientific can assist your QC processes via assessment of:
      • Potency
      • Stability
      • Comparability
      • Identity: peptide mapping, sequencing etc.
      • Product related impurities: aggregates, degradents
      • Process-related impurities: LPS, Host Cell proteins, Host Cell DNA
      • Typical technologies used : PAGE, HPLC, SEC, IEX, IEF, ELISA, CELL-BASED, HYBRIDISATION, etc.
      Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration
      • Cell-based assays
      • Life Scientific possess an expertise in the development and validation of in vitro assays for evaluation of biological effects. This service may facilitate Potency and Neutralisation investigations. Typical formats performed include:
      • Proliferation : quantification of growth stimulation
      • Cytotoxicity : quantification of growth inhibition
      • Differentiation : investigation of cellular marker profiles
      Preclinical Phase I, II, III Phase IV
    • BioPharm Services Primary services Method Development Method Validation Analysis Safety Efficacy Evaluation (Pre)Clinical PK Immunogenicity Neutralisation Biomarker QC Purity Potency Stability Identity GLP GMP Registration Life Scientific provides regulatory affairs expertise on tap to help solve your registration and licensing issues. We offer a complete range of services, throughout Europe, from strategic consulting to maintenance support. Preclinical Phase I, II, III Phase IV
    • Partnering with Life Scientific
      • Time efficient method development and validation expertise
      • Additional capacity for time sensitive projects
      • Skill sets that compliment current in house capabilities
      • Additional assurance of reaching in house milestones
      • An Analytics and Regulatory solution to those who wish to operate a (semi) virtual model
    • Quality Systems
      • Our laboratories were the first within Ireland to obtain GLP certification
      • Our Quality Systems are based on Standard Operating Procedures
      • We perform Routine self-inspection and welcome client facility inspections
      Science, the method of attaining knowledge by verifiable means
    • Contacts Biopharmaceutical Division NovaUCD, Belfield Innovation Park, UCD, Dublin 4, Ireland Tel: +353 1 716 3511 Andy Roche [email_address]