RESOLVING ISSUES.REDUCING RISK.PROVIDING PEACE-OF-MIND.

Outline

• Introduction to Advanced Testing Laboratory “The Science of Testing, The Art of

Serving” - Explained• Review ATL Core Services Onsite Managed Services Advisory Services Biological & Analytical Sciences

• Future Focus• Our Primary Point

Introduction to ATL

• Founded in 1987• Corporate Office In Cincinnati, OH.

Additional management office in Indianapolis, IN Onsite Support Locations Across the US

• Housed within 101,000 sq/ft facility situated on 6 acres. 70,000 sq/ft of Laboratory Space

• Space reserved for client specific expansion• LIFT and SHIFT Capability

• Fortune 100 Clientele

Introduction to ATL

The Industries/Markets We Serve:• Beauty Care• Health Care• Home Care• Pharmaceuticals• Medical Devices• Nutraceuticals• Food

Introduction to ATL

Onsite Managed Services

Analytical & Biological Services Advisory Services

ATL is designed to support your science based needs across your entire product

life cycle

Science + Art“The Science of Testing, The Art of Serving” Explained

Across the spectrum of our capabilities and services, Science is at the core of what we do.• Commitment to Quality (Accurate, Proficient,

Results Oriented) cGMP FDA Registered

• Operational Excellence Well Trained and Experienced Compliant to Procedures Sound Technique Planned Approach

Science + Art“The Science of Testing, The Art of Serving” Explained

While Science is our method, providing excellent Service is our Goal (Agile & Responsive)So…We seek first to UNDERSTAND• What is the Goal?• What Challenges Exist?• What are the Current Processes?• How do we Ensure Quality?• How do we Provide the Client with the Desired

Level of Control?• What Changes are Needed?• What does Success Look Like?

Science + Art = Value

Innovation + Quality + Service•Holistic Approach •Vision to Resolve

Challenges•Proficient at

Developing Specific Solutions to Achieve

Goals

•Depth of Experience in

Primary Markets•Strong

Technical Competencies•Compliance

Expertise•Metrics

•Oriented to Our Client’s Agendas•Prepared to Act

•Proactive Ownership

•Continuous Presence

•Custom Solutions

How do we deliver Value?

ATL Services Continuum: We support, manage and own a broad

array of key functions and services spanning the entire Product Life Cycle

Onsite Managed Services

If you could would you like to?• Amplify Capability• Accelerate Product Development• Realize Operational PotentialAs well as?• Reduce Costs• Increase Productivity• Augment your technical expertise

In today's environment our clients are having to solve for:• Resource Reduction, Less People & More Work, Do

More with Less• Oversight of Processes, Procedures and Results• Bottlenecks and Backlogs• Management of Hiring, Training, and Personnel

Development• Daily oversight of Associates, Workloads, Schedules

and Output• Trying to Reach Organizational Goals While High

Value Associates work on Low Value Activities

ATL Understands both what you are confronted with and how to deliver solutions.• Reduce Management’s Costs and Increase their

Effectiveness• Lower Operational Costs• Increase Productivity• On-demand Access to Expertise• Scalability / Flow to Work• Support for your Team in their Goals and Objectives

& meeting your Time Frames• Delivering on Specific Processes, Requirements,

and Running Key Functions

Examples of our Functional Support Services

•Discovery Biology•Cell Culture•Biochemical Assays•Molecular •Microbiology Testing Support•Bio-Analytical Chemistry•Quantitative & Structural Biology (Lead Optimization Biology)•Project Coordination•Technical Document Management•Radiation Safety•Clinical Support•Upstream R&D

•Product Safety•Regulatory Affairs•Central Product Safety•Product Release•Quality Control•Physical Testing•Product Development•Pilot Plant Support•Process Support •Sample Preparation•Mechanical Testing•Electronics Testing•Evaluation and Prototyping•Material Characterization•Packaging Testing

•Life Cycle Testing•Environmental Conditioning•Equipment Maintenance and Calibration•Development of Procedures•Supply Order•Stock Room Management•Sample Program Management•Data Management and Reporting•Managed Service Provider•Product Formulation•Method Development

ATL provides access to Industry Leading Technical Expertise. Our support team understands your business, your challenges, and your opportunities.• Improve Operations, Validate and Advance Internal

Processes, Drive Results Product Design, Optimization, Formulation, Validation

Support, GAP AnalysisAdvisory Services

Increase Quality, Reduce Risk, Improve Accuracy and Results• Environmental Monitoring and Design

Develop Routine Sampling, Testing, and CAPA Programs

• Investigation Support Sampling Techniques, Audits, Training

• Cleaning Effectiveness (Techniques, Procedures, Validations)

• Method Development, Optimization, Validation and Transfer Support

• Training Techniques, Methods and cGMP Requirements

Special Services and Support• Investigations / Audits / Training• Equipment / Process Validation• Procedure Development• Quality Engineering• Health, Safety & Environmental

ATL’s professional staff has extensive cGMP experience in your industry.

Analytical & Biological Services

ATL’s capabilities include a wide range of Methods and Testing for:• Raw Materials Finished Goods• Environmental • Product Development and Effectiveness

We make it easy for you to meet the regulatory requirements of your industry• USP, CTFA, AOAC, ASTM, EP, BP, JP, ACS

Biological Services• Testing Support

▪ Microbial Limits▪ Environmental

Monitoring▪ Celsis

AkuScreen / RapiScreen

▪ VIDAS®

• Microbial Susceptibility Services▪ Zone of Inhibition (ZOI)▪ Time Kill Assays /

Minimum Inhibitory Concentration (MIC)

▪ Disinfectant Efficacy▪ Preservative Efficacy

Biological Services• ATL delivers a wide range of Methods for detection

of Microbial Contamination CTFA: M1, M2, M3(process water, environmental

samples, finished packaging) USP <61>, <62> Client Specific/Developed & Client Transferred Methods

• Method Validation Services ASTM E1054 USP <61>, <1227> Client Specific/Developed Procedures

Biological Services• ATL Provides Solutions for Additional

Microbiology Needs as well:• Stability/Shelf Life Studies• Environmental & Manufacturing Validation

Testing• Enzyme Assays• Organism ID• Cleaning Validation• Container Closure Testing (Microbial

Ingression)

Analytical ServicesOur experienced and knowledgeable staff is capable of providing a broad range of services to assist with any requests • Raw Materials Qualification / Vendor

Qualification• Product Release Testing for any formulation• Stability Testing and Support• Comparative Product Testing• Method Development and Validation

Analytical ServicesAnalytical Method Development, Validation, Optimization and Transfer is a large part of the work we provide.• Dedicated Validation Team• ICH/cGMP Compliant Method Validations• Assay, Purity, and Stability Indicating Methods in

Multiple Formula Types• Capable of Development and Validation for

Transfer to your Facility

Analytical ServicesOur Chemistry Department houses an extensive range of analytical methods and testing capabilities• AA, ICP• GC, HPLC, IC, TLC• FTIR & UV Spectroscopy• Karl Fisher, Viscosity, Turbidity, AutoTitration• Loss on Drying/Gravimetric Analyses• ROI, Polarimetry, Conductivity• TOC• Residual Solvents• Heavy Metals

ATL is uniquely positioned to provide technical solutions and support through the entire product development lifecycle.

Future Focus

Consumer Product

Use

Consumer Needs

Discovery Development Commercialization

Providing Technical Solutions Across the Entire Development Lifecycle

Technology ID & Concept

Development

Product Development & Claim Support

Process Development &

Scale Up

Manufacturing & Product Delivery

Marketing Support

• Raw Material or New Ingredient Testingo Microbiologyo Analytical o Physicalo Cell culture

• New Technology ID• Vendor/Supplier Audits• Equipment

Management (process outsourcing)

• Part II Compliance Assessment

• cGMP Systems Assessment

• Molecular Biologyo Immunoassayso Western blotso qPCRo Cell /Biochem

assayso Protein purification

• Phlebotomy• Biochemistry

o Bioanalyticalo Metabolism

• Pathology/Histology• Radiation Safety• Project Coordination

o Bespoke project coordinators

o Financialo Regulatoryo Collaboration

mgmt• Asset Management

• Micro Susceptibility Testing (MST)

• R&D Lab Operations Management

• Flushability Testing• PS&RA – Safety &

Regulatory• Raw Material

Qualification Testing• Non-Regulated Claims

Support• Method Validation• Method Development• Regulatory Consulting• Raw Materials Supply

Chain Quality Management Launch

• LAB Management Productivity Analysis

• Benefit Modeling• Raw Material Supply• Chain Quality

Management – On-going

• LAB Network Management

• Environmental Monitoring

• In Process/Intermediate Testing – Validation

• Scale Up & Batch Testing

• Finished Product Testing – Validation

• Process Flow Efficiencies/Development

• Cleaning Method/Program Development

• Procuremento Supplieso Consumableso Instruments

• Flow to Work Staffing Model

• Process Consolidation over Multiple Sites

• Business Continuity Management

• Industry Best Practices Introduction

• Facility Utilization Options

• Cleaning & Sanitization (C&S)( Validation

• M-Vac to Replace Swab Testing

• Rapid Release – Celsis• Tanker Wash• In

Process/Intermediate Testing - Release

• Swab (cleaning val)o Chemistryo Micro

• Raw Material Testing –Release

• Cleaning Validation• Finished Product

Testing – Release• Stability Testing• Component – Release • CoA Verification• Raw Material

Confirmation Testing• Method Enhancement• Raw Materials Supply

Chain Management• Lab Efficiency

Consulting

• Competitive Analysiso Micro claimso Composition or

performance claims

• Package Testing (engineering)

All of ATL’s Current Capabilities were designed to fulfill specific industry or customized client needs.

Our Process is Designed to Engage OurClients on a level that allows us to truly understand their needs, goals and difficulties.

It is Not About What We Currently Provide Today but more importantly about what we can develop as a solution for our clients tomorrow.

Our Primary Point

THANK YOU!

Questions?