This presentation describes the different services and capabilities offered by Advanced Testing Laboratory (ATL). Serving the consumer products manufacturing and R&D industries, we support, manage and own a broad array of key functions and services spanning the entire product life cycle. ATL provides access to industry leading technical expertise. Our support team understands your business, your challenges, and your opportunities. Analytical method development, validation, optimization and transfer is a large part of the work we provide. All of ATL’s current capabilities were designed to fulfill specific industry or customized client needs. Our process is designed to engage our clients 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.

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

2. 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

3. 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

4. Introduction to ATL
The Industries/Markets We Serve:
• Beauty Care
• Health Care
• Home Care
• Pharmaceuticals
• Medical Devices
• Nutraceuticals
• Food

5. 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

6. 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

7. 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?

8. 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?

9. 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

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

11. 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

12. 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

13. 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

14. 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 Analysis
Advisory
Services

15. 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

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

17. ATL’s professional staff has extensive
cGMP experience in your industry.
Analytical &
Biological Services

18. 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

19. 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

20. 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

21. 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)

22. Analytical Services
Our 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

23. Analytical Services
Analytical 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

24. Analytical Services
Our 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

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

26. 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 Testing
o Microbiology
o Analytical
o Physical
o Cell culture
• New Technology ID
• Vendor/Supplier Audits
• Equipment
Management (process
outsourcing)
• Part II Compliance
Assessment
• cGMP Systems
Assessment
• Molecular Biology
o Immunoassays
o Western blots
o qPCR
o Cell /Biochem
assays
o Protein purification
• Phlebotomy
• Biochemistry
o Bioanalytical
o Metabolism
• Pathology/Histology
• Radiation Safety
• Project Coordination
o Bespoke project
coordinators
o Financial
o Regulatory
o 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/Developme
nt
• Cleaning
Method/Program
Development
• Procurement
o Supplies
o Consumables
o 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 Chemistry
o 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 Analysis
o Micro claims
o Composition or
performance
claims
• Package Testing
(engineering)

27. All of ATL’s Current Capabilities were
designed to fulfill specific industry or
customized client needs.
Our Process is Designed to Engage Our
Clients 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

28. THANK YOU!
Questions?