advanced testing laboratory services presentation
DESCRIPTION
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.TRANSCRIPT
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?