immunositetechnologies_glpservices

8/7/2019 ImmunoSiteTechnologies_GLPServices

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I M M U N O S I T E T E C H N O L O G I E S


GLP TESTING SERVICES FOR RESEARCHERS



W ADE BOLTON, PHD, CEO

IMMUNOSITE TECHNOLOGIES, LLC

27 years of distinguished work at

Beckman Coulter Inc., in senior

management R&D

Worked closely with industry legendsWallace Coulter and Joseph Coulter

Led the Custom Biopharma

Solutions (CBS) department to

address specific needs of

pharmaceutical industry, particularly

in preclinical and clinical trials



WHY IMMUNOSITE TECHNOLOGIES?

Quality, Integrity, Knowledge, Skills, and Expertise Over 110+ years combined management experience in FDA-regulated

industries

GLP testing services: Immunological Samples

Particle Characterization

Understanding the needs of researchers and manufacturers Biologics

Immune-based therapies

Quality Control

Experts in standardizing and automating

Converting research assays to GLP compliance

Standardizing complex functional immune assays

Automating assays for high precision results



IMMUNOSITE TECHNOLOGIES CLIENTS

Research Hospitals, University Medical Centers,and Research Consortia

count on IST¶s integrity and proven record for standardizedassessment of immune status and function

Pharma and Biotech companies work with IST as a trusted partner for developing, standardizing,

automating, and performing GLP immunological assays in pre-clinical, Phase I and Phase II clinical trials

Industrial Manufacturers depend on IST¶s particle testing service expertise and GLP

quality data for their quality control and quality assurance



A Total Quality Management System is fundamental to every aspect of IST¶s business GLP inspection readiness at all times

Regular internal audits

Early identification of systemic compliance risks

In-process QC measures are coupled with broad QA measures

IST¶s high integrity test data stands the test of time

An error-free performance standard is based on prevention and µright-

the-first-time¶ processes: Extensive instrument qualification, calibration, and

maintenance programs

Environmental monitoring of facilities and equipment Awareness of regulatory changes that impact our

business to ensure early compliance

Statistical techniques used for continuous quality improvementStatistical techniques used for continuous quality improvement

Rigorous training of personnel at all levels of the companyRigorous training of personnel at all levels of the company

IST - AN ORGANIZATION DRIVEN BY QUALITY



Validation of Cell-Based Assays in the GLP

Setting: A Practical Guide

Authors/Editors: UmaPrabhakar, Marian KelleyPublisher John Wiley and Sons, 2008

ISBN 0470028769, 9780470028766

Chapter 8.

Intracellular cytokine detection

by flow cytometryJulie G. Wilkinson, Carlos L. Aparicio, and Wade E. Bolton

IST SCIENTISTS HELP TO SET

GLP ASSAY V ALIDATION STANDARDS



Inspection-ready always

Full Quality Management System

Regular Internal and External Auditing

CAPA Program

Revision-Controlled Quality

Documentation System

Record Retention Program

Electronic Data Backup and Archive Systems

Disaster Response and

Business Continuity Plan

Vendor qualification program

Company QA UnitOff-Site Record Archives, Secure and

Controlled

On-Site Record Storage, Secure and

Controlled

Equipment Calibration/Certification

Environmental Control & Monitoring

Generator electrical power back upsystem

Instrument and equipment acceptance

testing

Instrument IQ/OQ/PQ

Instrument Point-of-Use QC/QA

Instrument Performance Monitoring24/7 Security Controlled Access to

Facilities

Employee training

Operator Qualifications

EHS Programs for Fed/State/Local

regulations

Chemical and reagent ID and traceabilitySample chain of custody from receipt to

discard

Data traceability to original sample

Privacy of sample and patient identifiers

Back up equipment and instruments

HIGHLIGHTS OF GLP AT IST



IMMUNE MONITORING



IMMUNE MONITORING AT IST



GLP IMMUNE MONITORING SERVICES & PRODUCTS

Proven AssaysProven Assays Off Off--thethe--shelf shelf

Standardized andStandardized and Automated Automated

CustomizedCustomized

Designed, Optimized,Designed, Optimized, Automated, and Validated Automated, and Validated

CellCell--Based:Based: in vitroin vitro functionalfunctional

PolyPoly--spectral flow cytometryspectral flow cytometry

ELISPOTELISPOT

Cell free:Cell free: EIAEIA

MultiplexedMultiplexed

Optimized Reagent ProductsOptimized Reagent Products Off Off--thethe--shelf shelf

Optimized ICS antibodycocktails for flow cytometry

CustomizedCustomized

Designed and optimizedantibody cocktail panels for flowcytometry



AUTOMATION & STANDARDIZATION AT IST

IST automates and

standardizes to enhance

assay precision and

accuracy

Completely automatedsystems with on-board

addition of all samples and

reagents, centrifugation, and

washingHands-free testing

IST uses automated workstations with

proprietary custom modifications on hardwareand software, as well as custom optimized

reagent combinations



P ARTICLE TESTINGP ARTICLE TESTING



GLP P ARTICLE TESTING SERVICES AT IST

Particle Size, Distribution,

Concentration, and Zeta

Potential

Method development

Performance qualification

Expertise in therapeutic drugs,

pigments, filler compounds,

toners, foods, abrasives, clay,

minerals, construction materials,coating materials, metals, and

many other sample types



P ARTNERSHIPSP ARTNERSHIPS



IST P ARTNERSHIPSWITH

WORLD CLASS ORGANIZATIONS




THANK YOU

IMMUNOSITETECHNOLOGIES.COM

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