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Biopharmaceutical Division Biopharmaceutical Division Overview Overview

Lsl Bio Pharm Linkedin 04 09a

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Page 1: Lsl Bio Pharm Linkedin 04 09a

Biopharmaceutical DivisionBiopharmaceutical DivisionOverviewOverview

Page 2: Lsl Bio Pharm Linkedin 04 09a

Life Scientific Ltd.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

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About UsAbout 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

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Biopharmaceutical DivisionBiopharmaceutical Division

Core expertise: development, validation and utilisation of proteomic, immuno and cell-based methodologies for the analysis of:

• Biopharmaceuticals

• Biomarkers

Biopharmaceutical Biopharmaceutical DivisionDivision

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BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

Registration

Page 6: Lsl Bio Pharm Linkedin 04 09a

BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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.)

Page 7: Lsl Bio Pharm Linkedin 04 09a

BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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

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BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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.

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BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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

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BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

Registration

Read Biomarkers in Drug Development in the February 2007 issue of Pharma Magazine

http://www.nxtbook.com/dal/viamedia/pharmadigitalfeb2007/index.php

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BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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.

Page 12: Lsl Bio Pharm Linkedin 04 09a

BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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:

1. Proliferation: quantification of growth stimulation

2. Cytotoxicity: quantification of growth inhibition

3. Differentiation: investigation of cellular marker profiles

Page 13: Lsl Bio Pharm Linkedin 04 09a

BioPharm ServicesBioPharm Services

Primary services Method Development Method Validation Analysis

Safety Efficacy Evaluation

(Pre)Clinical PKImmunogenicity NeutralisationBiomarker

QC PurityPotencyStabilityIdentity

GLP GMP

Preclinical

Phase

I, II, III

Phase IV

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.

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Partnering with Life Scientific Partnering with Life Scientific

• Time efficient method development and validationexpertise

• 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

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Quality SystemsQuality 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 Science, the method of attaining

knowledge by verifiable meansknowledge by verifiable means

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ContactsContacts

Biopharmaceutical Division

NovaUCD, Belfield Innovation Park,UCD, Dublin 4, Ireland

Tel: +353 1 716 3511

Andy [email protected]