Company Background• Bioclin is Ireland’s leading GLP, cGMP certified,

FDA compliant research laboratory – Winner of Pharmaceutical Lab of the Year 2016

• Established in 2002 and formerly part of the R & D division of a multinational Pharmaceutical company

• Joined Intertek plc. Feb 2008

• MBO 1 May 2013

• Preferred Provider Arrangement with Intertek

Accreditation• Awarded GLP certification by INAB in Nov 2003

(last full GLP inspection Dec 2015)

• Established cGMP analytical laboratory in 2005

• Awarded HPRA cGMP Certification (last inspection Jan 2015)

• Successfully inspected by the FDA in April 2014 with no 483 findings

Services Summary

Services Summary• GLP bioanalysis to support preclinical & clinical trials

• GLP / GCP / GMP analytical support for drug substance and drug product development

• GMP analytical support for process development and manufacturing

• GMP support for supply chain, vendor qualification, raw materials, QC testing

• Environmental Analysis

• Full Time Equivalence (FTE)

Customer Service• Standard turnaround time of 7-10 working days from date of sample

receipt

• Provision of an Express Service 24 /48 hours and 3 - 5 days

• Collection and Sampling Service available upon request

cGMP Chemistry

cGMP Chemistry AnalysisServices• Pharmacopoeia Analysis (Ph. Eur., USP, JP and BP.)• Method development & validation according to ICH guidelines• Remediation of old methods for existing products to bring them up to

current regulatory standards• Raw Material analysis• Investigative Analysis• Residual Solvent analysis• Drug substance & drug product analysis• Cleaning validation or verification • Stability testing & storage

Sample Types Powders, Capsules, Tablets, Suspensions, Topicals, InjectablesDrug Eluting Stents

cGMP Microbiology

cGMP Microbiology AnalysisServices• Microbial Limit Testing / Validation• Preservative Efficacy Testing/Validation• Incubation of Environmental monitoring Samples • Validation of Water Systems • Endotoxin testing • Growth Promotion / Fertility testing of culture media• Efficacy testing of detergents and disinfectants• Bioburden Validation and Analysis• Identification of bacterial cultures using a phenotypic method (BioLog)• Routine water testing

Sample Types Powders, Capsules, Tablets, Suspensions, Topicals, Drug Eluting Stents

Bioanalysis & Pharmacokinetics

Bioanalysis & PKBioanalysis Services Sample Types• Assay development & validation Plasma/serum/urine• GLP Bioanalysis Whole blood• Mass Spectrometry (LC-MS/MS) Tissues• Chromatography (HPLC)• Immunoanalytical Assays (ELISAs, RIA)• Clinical batch stability

Pharmacokinetics, statistics, protocol design & review

Study Management• CRO Selection• Preparation & distribution of blood sampling kits for single/muti-siteclinical studies

The laboratory has developed and validated over 250 methods from smallmolecules to large biologicals, covering all therapeutic areas

BioclinTechnologies

Bioclin TechnologiesChromatography –

HPLC systemsGC systems (incl. Headspace)

Dissolution

Stability - 25ºC/60%RH30ºC/65%RH40ºC/75%RH

Mass Spectrometry –LC/MS-MS systems

FTIR Spectrometer with ATR Assessory

Potentionmetric Titrator

UV Spectrometer

Physical Testing –Disintegration/Hardness

Karl Fischer

Particle Sizer

Immunoanalytical Assays (ELISAs, RIA)

Spectromax

BioRad• SDS Page, Western Blotting,

IEF, Gel ElectrophoresisAdditional Technologies

Highfield NMR

MALDI-MS, Raman Spectroscopy

ICP-MS, X-Ray Fluorescence, Elemental Microanalysis

Capillary Electrophoresis

Thermal Analysis – DSC and MDSC, TGA

Vibrational Spectroscopy

X-Ray diffraction

Thank You For Your Time

Any Questions?

Please visit our websitewww.bioclinlabs.com