Prestige BioResearch

SPECIALIZED IN GLP NONCLINICAL RESEARCH

A RELIABLE PARTNER IN YOUR DISCOVERY

PRESTIGE BIORESEARCH AAALAC Accredited GLP Research Laboratories

WWW.PRESTIGEBIORESEARCH.COM

Prestige BioResearch GLP Laboratories by PWG Genetics

P

restige BioResearch is a Singapore based GLP nonclinical CRO providing comprehensive research services in support of drug and medical device development to the clients worldwide.

P

Prestige BioResearch Singapore

With its proven track record and professional expertise in nonclinical and translational research, Prestige BioResearch became one of the top CROs in Asia offering GLP regulatory program services as well as a wide variety of efficacy trials for drugs and medical devices.

Our AAALAC accredited facilities are equipped with animal study rooms of rodents, minipigs, non-human primates, guinea pigs and rabbits, laboratories for clinical pathology, histopathology, cell biology, immunology, chemical analysis, bioanalysis and surgery/ imaging suites. OECD and US FDA GLP compliant studies supporting IND, NDA and medical device biocompatibility (ISO10993) are offered with high scientific standards and professionalism.

Professional study management and scientific quality ensured by highly trained scientific staff including DABT, ACVP, DVMs and PhDs

On-site Quality Assurance Unit for worldwide GLP compliance

15 Tech Park Crescent, Singapore 638117 Phone +65 6863 3042 Fax +65 6863 4834 Email info@pwgpig.com info@prestigebioresearch.com Web www.pwg.com.sg www.prestigebioresearch.com

State-of-the-art facilities, equipment, software and GLP data management system to produce top quality study reports

PHONE +65 6863 3042

PRESTIGE BIORESEARCH

Business Milestones Certification and Accomplishments

2005

Prestige World Genetics, USA Establishes a Spin-off Company, PWG Genetics Pte Ltd in Singapore

2007

Establishment of PWG Laboratories in Tuas Biomedical Park, Singapore

2009

Singapore AVA Registration as Animal & Biomedical Research Facility

2010

AAALAC Full-accreditation by AAALAC International for World Standard Animal Care System

2011

Establishment of Good Laboratory Practice (GLP) System in Compliance with US FDA

2012

OECD GLP registration by Singapore Accreditation Council (SAC)

2013

AAALAC Accreditation Renewal

2015

CRO Business Spin-off as Prestige BioResearch GLP Laboratories

GLP

Good Laboratory Practice

Prestige BioResearch Singapore

Proven Excellence in Provision of Biomedical Research Services PRESTIGE BIORESEARCH

GLP General Toxicology Prestige BioResearch provide GLP general toxicology study services

TYPES OF STUDY

ADMINISTRATION ROUTE

General Toxicology in Rodents – Acute (OECD 400 series) – 7, 14, 28 Days DRF – 4, 13, 26, 52 Weeks

Oral Dosing – Gavage, Capsule, Dosed Feed

Rodents

Dermal Application – Cream, Gel, Ointment – Transdermal Patch

Minipig

General Toxicology in Minipigs / NHP – Dose Escalation / MTD – 14, 28 Days DRF – 4, 13, 26, 39, 52 Weeks

ANIMAL SPECIES Mouse, Rat

PWG Micropig®

Parenteral Routes – SC, IP, IM and IV bolus – Continuous IV infusion

Non-Human Primates Cynomolgus Monkeys

STUDY FLOW Pre-dose

Plan Study Selection of Test System Dose Level / Administration Route / Frequency / Study Period

Randomization Acclimation Veterinary Examination Rooms and Equipment Preparation and Validation

Protocol Approval Pristima Protocol Generation Work Scheduling Test Article Receipt IACUC

Archive Post-mortem Scheduled Data Collection and Sacrifice Necropsy Histopathology

Formulation and Dosing Scheduled/unscheduled Data Collection Clinical Pathology/Analysis

In-life

Study Raw Data Protocols / Report Microscopic slides and Specimen Test Articles

Submission of QA Audited Final Report with GLP Compliance Statement and QA Statement

Reporting Study Set-up PHONE +65 6863 3042

PRESTIGE BIORESEARCH

Clinical Pathology

&Standard Full List

PBR’s clinical pathology lab is equipped with high-quality automated equipment and system interfaced with Pristima.

Siemens ADVIA 2120 Analyzer Siemens Dimension Xpand Plus Clinical Chemistry Analyzer Siemens Clinitek Advantus Urinalyzer Siemens Sysmex CA-620 Coagulation System Hematology WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT, RDW, CHCM, HDW, MPV, Relative (%) and Absolute (#) value of Granuloctyes (Neut, Eos, Baso), Mono, Lympho, Retic and Large Unstained Cells Serum Chemistry AST, ALT, ALP, GLU, Tprot, ALB, BUN, Crea, Trig, TBili, Chol, Ca, P, GGT, Na, K, Cl Urinalysis Specific gravity, pH, GLU, Bil, KET, BLD, Pro, UBG, NIT, LEU Coagulation PT, APTT, Fibrinogen, Factor Deficiency, Heparin, vWF

Histopathology and Peer Review Necropsy

Histopathology

* Gross Observation / Findings * Organ Weight Stations Interfaced with Pristima * Organ/Tissue Collection and Fixation for Histopathology

* H&E Staining * Masson’s Trichrome Staining * Special Staining * Immunohistochemistry Microscopic Examinations and Peer-Review by Certified Veterinary Pathologists and ACVP

Analytical PK/TK Study * Formulation Analysis and Bioanalysis for Chemical and Biologics * Analytical Method Validation * Pharmacokinetics (PK) / Toxicokinetics (TK) * Anti-drug Antibody Analysis and Neutralizing Antibody Analysis Shimadzu LCMS-8030 Triple Quadrople Liquid Chromatograph Mass Spectrometer (LCMS/MS) Shimadzu Prominence Ultra Fast LC (HPLC) TECAN Sunrise™ ELISA System

PRESTIGE BIORESEARCH

www.PRESTIGEBIORESEARCH.COm

AMES Bacterial Reverse Mutation, OECD 471 Chromosomal Aberration, OECD 473

– CHO or V79 (CHL) cells

– Human Lymphocytes Mouse Micronucleus Test, OECD 474 Mouse Lymphoma Assay, OECD 476

Genetic Toxicology Safety Pharmacology Antigenicity & Local Irritation Reproductive Toxicology Carcinogenicity

ICHS7A/B Core Battery CNS – Irwin Behaviour CV – Minipig and NHP Telemetry Respiration – Whole Body Plethysmography QT-Prolongation– hERG Assay

Guinea pig – Passive Cutaneous Anaphylaxis (PCA) – Active Systemic Anaphylaxis (ASA) – Skin Sensitization, OECD 406

– Guinea Pig Maximization Test

– Buehler Repeated Patch Test Rabbit – Skin Irritation, OECD 404 – Eye Irritation, OECD 405

Fertility Study Teratogenicity, OECD 414 Peri- and Postnatal Study, OECD 414 One Generation Reproduction Toxicity, OECD 415 Two Generation Reproduction Toxicity, OECD 416

Short Term Carcinogenicity – Transgenic Mouse, 6 months 2 Year Bioassay in Rodents Combined Chronic/Carcinogenicity

PHONE +65 6863 3042

PRESTIGE BIORESEARCH

Special Toxicology

n

Juvenile Study in Minipigs * Required for pediatric indications * Possible in all routes of administration * Advantageous at PBR in terms of juvenile animal availability and experimental skills in Micropig * Special acclimation to reduce weaning stress and training for study procedures and handling * Enhanced environmental enrichment

L

Minipig Reproductive Toxicology Minipig is advantageous for reproductive toxicology due to large litter size. Segment 1 and 2 reproductive toxicology can be conducted in minipigs and recommended for drugs unďŹ t for rodent or rabbit studies due to metabolic proďŹ le.

Dermal Studies and Wound Healing Micropig is the most suitable model for dermal studies and wound healing.

8

PRESTIGE BIORESEARCH

* Dermal toxicology: single dose to up to 52 weeks repeated dose on cream, gel, ointment or transdermal patches * Skin irritation study * Wound healing study * Investigative studies to evaluate skin therapy or product

www.PRESTIGEBIORESEARCH.COm

PBR ensures the best scientific and GLP quality in all studies GLP Computer System

Animal Rooms with Environmental Control

Quality Assurance

Archive

PBR’s on site Quality Assurance Unit (QAU) ensures compliance to worldwide GLP requirements.

PBR’s GLP Archives are operated in accordance with documented SOPs with stringent environmental and security control.

Prestige BioResearch uses the most up-to-date computer GLP system Software in compliance with worldwide GLP Regulations

GLP Data management system, Pristima (US FDA CFR 21 Part 11 compliant) from Xybion Medical Systems, USA.

Animal Room – Animal Assignment and Data Collection Clinical Pathology Necropsy – Organ Weight and Lists Pathology – Gross Finding – Microscopic Examination – Peer Review Reproductive toxicology Study Design – Protocol Setup / Approval – Schedule Activities

Audit to ensure completeness and accuracy of study adhering to GLP requirements Study audits on critical phases and overall conduct of study

GLP Document Archive Test Article Reserve Specimen Archive for Wet Tissues, Paraffin Blocks and Microscopic Slides

Procedural audits for repeated study procedures as well as facility audits to ensure overall compliance

Statistical Analysis and Report – Data Management – Archive

PHONE +65 6863 3042

PRESTIGE BIORESEARCH

Efficacy and Discovery Using Micropig Disease Models

&

A variety of human disease models can be created in pigs via chemical or dietary induction as well as genetic modifications. PWG has developed unique Micropig disease models to offer the customized efficacy trials in GLP settings.

Chemical Induction Diabetes - Streptozotocin (STZ)-induced diabetic Micropig model Parkinson’s Disease - MPTP-induced Parkinsonism Micropig model Rheumatoid Arthritis - Collagen-induced Rheumatoid arthritis Micropig model Achondroplasia - The first mammalian dwarfism (Achondroplasia) Micropig model

Surgical Induction Osteoarthritis - Degeneration of joint cartilage and the underlying bone by meniscectomy Bone, Cartilage, Skin defect models Dietary and Combined

Atherosclerosis - High fat & high cholesterol diet Hyperlipidemia - High fat & high cholesterol diet Hypertension - Nephrectomy and high sodium diet Osteoporosis - Ovariectomy and low Calcium diet

Others PRESTIGE BIORESEARCH

Transgenic Micropigs

www.PRESTIGEBIORESEARCH.COm

Medical Device Evaluation & Training with professional veterinary surgery, care and diagnostic services

Gastrointestinal Devices

Cardiovascular Devices

Orthopedic Implants

Dental Implants

Tissues and Organ Regeneration Device / Therapy Anesthesia & Monitoring Vascular & Peritoneal Catheterization Pre and Post-op Care

PBR’s surgical suites are equipped with anesthesia units, physiology monitor, C-arm X-ray and ultrasound enabling on-site imaging, angiography and echocardiography.

Medical training for various types of medical devices and therapy can be conducted at PBR.

PHONE +65 6863 3042

PRESTIGE BIORESEARCH

Medical Device Biocompatibility Test ISO10993 Biocompatibility Series under GLP

ISO10993-3 Genotoxicity

ISO10993-6 Implantation

* AMES Test (Bacterial Reverse Mutation Test) * Mouse Lymphoma Assay * Mouse Micronucleus Test * Chromosome Aberration

* Acute * Sub-acute (Sub-chronic) * Chronic

ISO10993-4 Hemocompatibility

ISO10993-10 Sensitization & Irritation

* Hemolysis * Prothrombin Time * Partial Thromboplastin Time * Complement Activation * Platelet Aggregation & Count * Platelet Activation * in vivo Thrombogenicity

* Guinea Pig Maximization Test * Buehler’s Repeated Patch Test * Local Lymphnode Assay * Primary Skin Irritations

ISO10993-5 Cytotoxicity

ISO10993-11 Systemic Toxicity & Pyrogenicity

* MEM Elution * Agar Diffusion * MTT Evaluation * Colony Formation

* Acute * Sub-acute (Sub-chronic) * Chronic * Rabbit Pyrogenicity

Prestige BioResearch offers full series ISO10993 studies in compliance with US FDA and OECD GLP. Biocompatibility testing is required for the registration of medical devices that come into contact with body and now required to be conducted under GLP.

PRESTIGE BIOReSEARCH

www.prestigebioresearch.com

Bio-imaging Centre The state of the art, one-stop Imaging Services Combined with the well designed operation theatres and surgery services, Prestige BioResearch can provide a onestop research services in medical device evaluation and efficacy studies.

Siemens 1.5T MRI Shimadzu High Resolution SMX-100CT Micro-CT E Vista Micro PET Genoray C-arm X-Ray Radio/Fluoroscopy GE Healthcare Logiq C5 Premium Ultrasound Echocardiography Angiography

* SPF PWG Micropig® * Whole Blood * Serum * Plasma * Skin (Fresh/Frozen) * Organs and Tissues * Hepatocytes * Liver Microsome * S9 Fraction

&

Bioresource Supply PWG Micropigs and research material of laboratory animal species are available for distribution.

BSL-3 equivalent Laboratory

Air-tight sealed BSL-3 equivalent laboratory is equipped with animal isolators, fume hood, necropsy station and auxiliary lab instruments for conducting hazardous agent challenge or exposure experiments in large animals.

Exhaust air is filtered by NBC filter to meet the standards in CBRNe research.

Specialty Research

COPYRIGHT © 2014-2015 PRESTIGE BIORESEARCH PTE LTD ALL RIGHTS RESERVED