SERVICES

GLP | GMP | ISO/IEC 17025:2017 accredited | ISO 9001 compliant | FDA registered | DEA licensed | A2LA accredited #3383.01 & 3383.02

THE ALG STORY

Analyti cal Lab Group (ALG) – Helping Protect Life™ by providing the most comprehensive FDA and EPA testi ng soluti ons.

ALG is an industry leader in the specialty lab space and comprises FDA- and EPA-focused laboratories across the United States, with faciliti es in San Francisco, Minneapolis and Boston. Our ALG team is focused on Helping Protect Life™ through infecti on preventi on, with the most comprehensive testi ng soluti ons in the anti microbial, pharmaceuti cal, medical device, biotech and healthcare spaces. Our faciliti es are GLP/cGMP compliant, FDA registered, DEA licensed, and ISO/IEC 17025:2017 accredited.

Each of ALG’s three labs partners with CMOs, CDMOs, 503B Human Drug Outsourcing Faciliti es, 503A compounding pharmacies, anti microbial, pharmaceuti cal, medical device, biotech and healthcare developers and manufacturers to provide FDA compliance experti se and testi ng soluti ons. The labs boast their own specialty services, while off ering clients comprehensive testi ng soluti ons and personalized service.

TOOLS

M-FILES: ELECTRONIC REPORT DELIVERY SYSTEMM-Files is an enterprise informati on management soluti on that will provide our clients with:

+ Instant email noti fi cati on when your test results are released and available

+ Secure 24/7 access to your test result informati on+ Downloadable results from our portal

COMPLIANCE ON DEMAND™ PROFICIENCY KITSChoose Analyti cal Lab Group’s Compliance on Demand™ kits and testi ng services to validate confi dence in your asepti c procedures and work surfaces.

We off er fi ve kits:

+ Medium Complexity+ High Complexity+ Multi ple Technician+ Surface Sampling+ Glove Fingerti p Sampling

Contact cod@analyti callabgroup.com to learn more

or to order kits.

MINNEAPOLIS/ST. PAUL BOSTON

SAN FRANCISCO

HOURS OF OPERATIONEAST COAST

Monday-Friday: 9 a.m. to 5:30 p.m.

MIDWEST

Monday-Friday: 8 a.m. to 4:30 p.m.

WEST COAST

Monday-Friday: 8 a.m. to 4:30 p.m.

HEADQUARTERS

1285 Corporate Center Drive, Ste 110Eagan, MN 55121

(877) 287-8378

info@analyti callabgroup.comanalyti callabgroup.com

TESTING SERVICESAnti microbial Effi cacyincluding pre-saturated towelett es+ Microbiology Testi ng

• Anti microbial properti es evaluati on• Bacteria and mold identi fi cati on• Bacterial endotoxin• Bacteriostasis and fungistasis• Bioburden/microbial enumerati on test• Biological indicators (BIs) for sterility• Container closure studies• Media incubati on and growth promoti on• Microbial bactericidal concentrati on (MBC)• Microbial inhibitory concentrati on (MIC)• Microbial limits/enumerati on test• Parti culate analysis per USP• Sterility testi ng - including rapid sterility• Water sampling and testi ng

+ Saniti zersfood contact and non-food contact surfac es

• Residual self-saniti zer with wear» Carpet

» Laundry

+ Sporicides

+ Disinfectants• Bacteriocidal• Virucidal• Fungicidal• Tuberculocidal• Biofi lm testi ng• Clostridium diffi cile and Candida auris

testi ng• Laundry Disinfectant

+ Virology Testi ng Services+ High Level Disinfectants/Liquid

Chemical Sterilants+ Germicides/Biocides

Fogging and Misti ng Effi cacy+ Bacterial disinfecti on+ Virucidal disinfecti on+ Non-food contact saniti zati on+ Food contact saniti zati on

Pesti cide Device Effi cacyCustom Effi cacy Testi ng

Treated Arti cle Effi cacy/Texti les+ Anti microbial fi nishes on texti le

materials - AATCC 100+ Bacterial and Virucidal JIS Z2801+ Determinati on of Anti microbial

Acti vity of Immobilized Agents - ASTM E2149

+ Method for Determinati on of Anti microbial Acti vity in Polymeric or Hydrophobic Materials - ASTM E2180

Liquid Effi cacy+ ASTM E2315 Time Kill Assay+ ASTM E1052 Viral Suspension Assay+ Minimum Inhibitory

Concentrati on (MIC) Test+ Minimum Bactericidal Concentrati on

(MBC) Test

ANTIMICROBIAL

cGMP CELL BANK PRODUCTION AND CHARACTERIZATION+ Mammalian Cell Bank

• Manufacturing of cGMP Master and Working Cell Bank• Full Cell Bank Characterizati on Testi ng

» Identi ty, Viability, Microbiological Contaminants, Retroviruses, Adventi ti ous Viruses, Anti body Producti on, Geneti c Stability

+ Microbial Cell Bank• Manufacturing of cGMP Master and Working Cell Bank• Full Cell Bank Characterizati on Testi ng

» Identi ty, Viability, Purity, Bacteriophage, Geneti c Stability

SAFETY TESTING+ Microbiological Contaminants

• Sterility

• Mycoplasma

+ Retroviruses• Infecti vity Assays• PCR-Based Assays

+ Adventi ti ous Viruses• In vitro assays for viral contaminants

+ Endotoxin: LAL+ Biological Reacti vity and Cytotoxicity+ Residual DNase, RNase and Protease Acti viti es+ Cells at the limit of in vitro cell age or end of

producti on cells+ Unprocessed Bulk+ Final Filled Product

CELL BANKING

CHEMISTRY

ANALYTICAL CHEMISTRY

ALG provides a wide range of cGMP chemical testi ng for drug substance (API), drug product and excipients. Our dedicated team is focused on development, qualifi cati on and validati on of test methods suitable for your intended purpose.

ALG experti se can help with test method selecti on and specifi cati on determinati on to ensure your development project meets ICH Q6A.

+ Drug Substance and Product Release and Stability

+ Method Development (HPLC, GC, etc.)+ Method Qualifi cati on / Validati on

• USP <1226>• ICH Q2(R1)

+ Comparati ve Testi ng+ Stability Testi ng and Storage+ Beyond Use Date+ Medical Device Support+ Viscosity

+ Density

+ Client-Specifi c Method Transfer

INSTRUMENT CAPABILITIESAll instrumentati on is calibrated to the highest standards and certi fi ed for use in cGMP and GLP studies.

+ Chromatography• High Performance Liquid Chromatography

» UV/Vis Detecti on» Photo-Diode Array Detecti on» Refracti ve Index Detecti on» Fluorescence Detecti on» Gas Chromatography» Flame Ionizati on Detecti on (FID)» Thermal Conducti vity Detecti on

(TCD)• Thin Layer Chromatography

+ Opti cal Microscopy+ Spectrophotometer

• Ultraviolet• Fourier Transform Infrared

Spectroscopy

• Polarimetry

• Refracti ve Index+ Viscosity

• Kineti c• Rheometer

+ Titrimetric

COMPENDIAL TESTING (USP, NF, IP, JP, EP Pharmacopeia test)

+ Identi fi cati on+ Raw Material Analysis

+ Compendial Drug Product Release Testi ng• Identi fi cati on USP <191>• Dissoluti on USP <711>,

Apparatus 1 and 2• Parti culate Matt er USP 788>• Water Content USP <921>• Microbiological Examinati ons

» USP <61> and USP <62> Microbiological Examinati on of Nonsterile Products

» USP <71> Sterility Test» BacT/Alert® Rapid Sterility Testi ng» USP <85> Bacterial Endotoxins

ANALYTICAL LAB GROUP IS DEA LICENSED FOR

SCHEDULES II-V.

PRODUCT CHEMISTRY+ Enforcement Analyti cal

Method+ Chemical Characterizati on+ Preliminary Analysis

+ Forced Degredati on Studies + Accelerated and Long-Term

Storage Stability+ ICH Q1A(R2) Stability Studies+ ICH Q2(R1) Analyti cal Method

Validati on+ Physical Chemistry

• pH• Color

• Odor

• Density - Specifi c Gravity• Viscosity

• Physical State• Flash Point/Flammability• Oxidati on/Reducti on Chemical

Incompati bility

TESTING SERVICESReusable Medical Device Validati on+ 510(k) Support+ Sterilizati on—Steam

+ Dry Time+ Disinfecti on—Low Level,

Intermediate Level, High Level

+ Cleaning (Manual)—with quanti tati ve endpoints: protein, hemoglobin, carbohydrate

High Level Disinfectant+ Simulated Use Testi ng on

Flexible Endoscopes+ Bench Testi ng, Simulated Use and

In-Use

Blood Glucose Meter/Point of Use DevicesCytotoxicity Testi ng/Rinsing StudiesUSP <1072> Disinfecti on Qualifi cati on+ Tube Diluti on Method+ Coupon Testi ng Using Immersion

Recovery Method+ Environmental Isolates and Viruses

USP <55> Biological Indicators—Resistance Performance Tests+ Total Viable Spore Count

(Populati on Verifi cati on)+ Identi fi cati on+ Purity

Biological Indicator Sterility Test+ Steam

+ Radiati on+ Dry heat+ ETO

ANSI/AAMI/ISO 11137 Bioburden for Medical Devices+ Bioburden Recovery Factor

for Medical Devices (Method Validati on)

+ Bioburden Testi ng+ ANSI/AAMI/ISO 11137

Sterility Tests+ VD Max Dose

Verifi cati on Sterility+ Method 1 Dose

Verifi cati on Sterility+ Membrane Filtrati on

Test for Sterility+ Direct Transfer

test for Sterility+ Media Growth Promoti on

Testi ng+ Method Suitability

(Bacteriostasis and Fungistasis Testi ng)

Cleanroom Sampling and Validati onUSP <161> Bacterial Endotoxin and Pyrogen Tests for Medical Devices+ Uti lizing Gel-Clot Technique

• Confi rmati on of Labeled Lysate Sensiti vity• Non-Inhibitory Concentrati on

Determinati on (Limit Test)• Test for Interfering Factors

(Inhibiti on/Enhancement Test)• Quanti tati ve Product Testi ng

+ Uti lizing Turbidimetric/Chromogenic Techniques (Photometric Techniques)• Assurance of Criteria for the Standard Curve• Test for Interfering Factors

(Inhibiti on/Enhancement Test)• Quanti tati ve Product testi ng

Endotoxin testi ng method+ Kineti c Turbidimetric+ Kineti c Chromogenic

Package Integrity Testi ng+ Microbial

immersion test

+ Dye leak test

Gamma and E-Beam irradiati on validati on (AAMI)+ Bioburden method development+ Bioburden recovery studies+ Bioburden studies for dose setti ng

Water Chemical Testi ng+ TOC+ Conducti vity+ Nitrates

Microbial Identi fi cati on Bacterial Water AnalysisCompressed Air/Gas Testi ngIntrathecal Delivery DevicesDrug/Device Interacti on Studies+ Refi ll Interval Determinati on+ Flow Rate Studies+ Impurity (L&E) Studies

MEDICAL DEVICE

TESTING SERVICESUSP <63> Mycoplasma Tests, EP 2.6.7, Mycoplasmas+ Culture (Direct) Method+ Indicator Cell Culture (Indirect)

Method+ Inhibitory Substances

(Mycoplasmastasis) Method+ Nucleic Acid Amplifi cati on Techniques

(NAT)• MicroSEQ Mycoplasma Real-Time PCR Assay• Comparability and Suitability Studies for

Use of NAT• Validati on of NAT

USP <87> Biological Reacti vity Tests, ISO 10993-5, Cytotoxicity+ Agar Diff usion Test+ Direct Contact Test+ Eluti on Test+ MTT Assay

Virucidal Effi cacy of a Disinfectant Applied to a Room via a Fogger or Misti ng Device

Custom Studies in Molecular Cell Biology and Virology + Assay Development and Validati on

• PCR

• ELISA

• DNA Electrophoresis (Supercoiled DNA Content, Restricti on Digest)

• Protein Electrophoresis (SDS-PAGE R & NR) and Immunoblotti ng

• Total Protein• Nucleic Acid Concentrati on and

Homogeneity+ Cell Line Generati on

• Cell Culture Expansion• Cell Viability Assay• Molecular Cloning and Expression Systems

+ Potency and Safety• Viral Cell-Based Assays (Plaque, Focus and

TCID50)• ViralSEQ Mouse Minute Virus (MMV) Real-

Time PCR Assay + Impurity

• resDNASEQ CHO DNA Real-Time PCR Assay• Residual DNase Acti vity Assay• Residual RNase Acti vity Assay• Residual Protease Acti vity Assay

Disinfectant Qualifi cati on Testi ng for Anti viral Acti vity

Virucidal Effi cacy Validati on of a Disinfectant Used to Clean and Disinfect the Exterior Surface of Blood Glucose Monitoring Devices Uti lizing Duck Hepati ti s B Virus as a Surrogate for Human Hepati ti s BVirucidal Effi cacy of a Disinfectant for use on Inanimate Environmental Surfaces+ Hepati ti s B Virus+ Hepati ti s C Virus+ Norovirus

ASTM E1052 Standard Test Method for Effi cacy of Anti microbial Agents Against Viruses in SuspensionASTM E1053 Standard Test Method for Effi cacy of Virucidal Agents Intended for Inanimate Environmental SurfacesAATCC 100 Assessment of Anti bacterial Finishes on Texti le Materials Modifi ed for Virucidal Effi cacy

MOLECULAR CELL BIOLOGY & VIROLOGY

MICROBIOLOGY TESTING SERVICESEnvironmental Monitoring+ Cleanroom EM

• Sample collecti on• Enumerati on and reporti ng for viable and

nonviable parti cles• Trained microbiologists

+ Compressed air/gas sampling• Hydrocarbon• Water vapor• Viable and nonviable parti cles

+ Cleanroom Validati on Services (IQ/OQ/PQ)

+ Water sampling• Purifi ed• WFI

+ Swab sampling

USP <51> Anti microbial Eff ecti veness Testi ng+ Suitability of the Recovery Method

(Neutralizer Validati on)+ Product Testi ng per Compendial

Product Category

USP <55> Biological Indicators—Resistance Performance Tests+ Total Viable Spore Count (Populati on

Verifi cati on)+ Identi fi cati on+ Purity

Biological Indicator Processing and Qualifi cati onUSP <60> <61> <62> Microbiological Examinati on of Nonsterile Products+ Tests for Burkholderia Cepacia

Complex+ Microbial Enumerati on Tests

• Bioburden Determinati on • Total Aerobic Microbial Count (TAMC)• Total Yeast and Mold Count (TYMC)

+ Tests for Specifi ed Microorganisms+ Method Suitability Tests+ Growth Promoti on Testi ng of Media/

Plates

USP <71> Sterility Test+ Method Suitability (Bacteriostasis

and Fungistasis Testi ng)+ Sterility by Membrane Filtrati on+ Sterility by Direct Inoculati on

Rapid Sterility Test Using BacT/Alert®USP <81> Anti bioti c Potency Testi ng

USP <85> Bacterial Endotoxins Test+ Gel-Clot Technique

• Confi rmati on of Labeled Lysate Sensiti vity• Non-Inhibitory Concentrati on

Determinati on (Limit Test)• Test for Interfering Factors (Inhibiti on/

Enhancement Test)• Quanti tati ve Product Testi ng

+ Turbidimetric/Chromogenic Techniques• Test for Interfering Factors (Inhibiti on/

Enhancement Test)• Product Validati on• Quanti tati ve Product testi ng

USP <1072> Disinfecti on Qualifi cati onUSP organisms, environmental

isolates and viruses

+ Coupon Testi ng Using Immersion Recovery Method

+ Tube Diluti on Method+ AOAC Use Diluti on Test+ Time-Kill Studies+ Fungicidal Acti vity Tests+ AOAC Germicidal Spray Products

Test+ Use-diluti on studies using coupons+ In-house organisms effi cacy studies+ Custom disinfectant effi cacy studies

USP <1112> Water Acti vity Determinati on for Nonsterile Pharmaceuti cal ProductsUSP <1116> Microbiological Control and Monitoring of Asepti c Processing Environments+ Full Service On-Site Environmental

Monitoring

+ Incubati on and Enumerati on+ Growth promoti on Testi ng of Media/

Plates

+ Cleanroom Validati on Services (IQ/OQ/PQ)

USP <1231> Water for Pharmaceuti cal PurposesMicrobial Identi fi cati on+ TOC+ Conducti vity+ Bioburden+ Endotoxin

ISO 14644-1 Classifi cati on of Air Cleanliness Certi fi cati onsGas Analysis+ USP/EP - Nitrogen+ USP - Medical air+ USP - Carbon dioxide+ USP - Oxygen

USP-EU Water Testi ng+ TOC (Total organic carbon)+ USP <791> pH+ USP Conducti vity+ EP Nitrates

+ Endotoxin+ Bioburden

Nutriti onal/Food Products+ Method Development+ Microbial limit test and Pathogen

screening (USP)+ Water Chemical Testi ng

Molecular Cell Biology & Virology Testi ng+ Mycoplasma detecti on+ Detecti on of viruses/residual DNA+ Cytotoxicity+ Cell Line Generati on+ Molecular Cloning and Expression

Systems

+ Bioproduct Safety Testi ng+ Cell Culture Services+ Disinfectant Effi cacy Studies (virus)+ Molecular Based Assays+ Host cell protein analysis+ Isoenzyme cell identi ty assay+ SDS-Page (R) & SDS-Page (NR)+ ELISA

+ Immunoblotti ng

COSMETICS

Aerobic Plate Count (APC)Fungi (Yeast and Mold) Plate CountAnaerobic Plate Count (Use only for Talcs and Powders)CTFA/PCPC Preservati ve Effi cacy Testi ng+ Suitability of the Recovery Method

(Neutralizer Validati on)+ Product Testi ng

CTFA/PCPC M-1-Determinati on of the Microbial Content of Cosmeti c ProductsCTFA/PCPC M-2-Examinati on for S. aureus, E. coli and P. aeruginosaUSP <1112> Water Acti vity Determinati on for Nonsterile Pharmaceuti cal Products

PHARMACEUTICAL

ANALYTICAL LAB GROUP IS DEA LICENSED FOR

SCHEDULES II-V.

STERILE COMPOUNDING PHARMACIES

PHARMACIES, HOSPITALS,

INFUSION AND STERILE COMPOUNDING FACILITIESUSP <797> Pharmaceuti cal Compounding-Sterile Preparati on+ Environmental Monitoring Program

Implementati on+ Full Service On-Site Environmental

Monitoring

+ Incubati on and Enumerati on/Genus ID for Environmental Monitoring Samples

+ Growth Promoti on Testi ng of Media/Plates

+ Cleanroom Validati on Services (IQ/OQ/PQ)

+ ISO 14644-1 Classifi cati on of Air Cleanliness Certi fi cati ons

+ Air Flow Visualizati on (AFV)+ Cleanroom Cleaning and Disinfecti on

Program Implementati on+ USP <1072> Disinfecti on

Qualifi cati on+ Compliance Gap Analysis

+ Staff Training• Staff media fi ll, gowning and gloving

profi ciency testi ng• Educati onal programs

USP <800> Hazardous Drugs-Handling in Healthcare Setti ngs+ Consultati on+ Compliance Gap Analysis

USP <51> Anti microbial Eff ecti veness Testi ng+ Suitability of the Recovery Method

(Neutralizer Validati on)+ Product Testi ng per Compendial

Product Category

Rapid Sterility Test using BacT/Alert®USP <71> Sterility Test+ Method Suitability (Bacteriostasis

and Fungistasis Testi ng)+ Sterility by Membrane Filtrati on+ Sterility by Direct Inoculati on

Endotoxin Testi ng by LAL Method+ Kineti c Turbidimetric+ Kineti c Chromogenic+ Gel Clot

Environmental Monitoring+ Cleanroom EM

• Sample collecti on• Enumerati on and reporti ng for viable and

nonviable parti cles• Trained microbiologists

+ Compressed air/gas sampling• Hydrocarbon• Water vapor• Viable and nonviable parti cles

+ Cleanroom Validati on

CGMP CONSULTINGUSP <1072> Disinfecti on Qualifi cati onUSP <1116> Microbiological Control and Monitoring of Asepti c Processing EnvironmentsUSP <1207> Sterile Product Packaging-Integrity Evaluati onUPS <1231> Water for Pharmaceuti cal Purposes, Water System Validati on (IQ, OQ, PQ)ISO 14644-1 Classifi cati on of Air CleanlinessANSI/AAMI/ISO 11135/11137-Sterilizati on of Health Care ProductsCompressed Air/Gas Testi ngMedia Fill

EDUCATION/TRAININGAsepti c ProcessingAsepti c Water SamplingCleanroom BasicsEnvironmental MonitoringPharmaceuti cal Water SystemscGMPUSP <797> Sterile CompoundingUSP <800> Hazardous Drugs-Handling in Healthcare Setti ngsCleaning and Disinfecti on

ANALYTICAL LAB GROUP IS DEA LICENSED FOR SCHEDULES II-V.

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WHO WE ARE

ALG is an industry leader in the specialty lab space and comprises FDA- and EPA-focused laboratories across the United States. Our ALG team is focused on helping protect life™ through infection prevention, with the most comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotechnology and healthcare spaces. Our facilities are GLP/cGMP compliant, DEA

licensed, FDA registered and

ISO/IEC 17025:2017 accredited.

MISSION: HELPING PROTECT LIFE™

MINNEAPOLIS/ST. PAUL BOSTON

SAN FRANCISCO

OUR LOCATIONS

info@analyticallabgroup.com AnalyticalLabGroup.com

HEADQUARTERS

1285 Corporate Center Drive, Ste 110

Eagan, MN 55121

(877) 287-8378

HOURS OF OPERATIONEAST COAST

Monday-Friday: 9 a.m. to 5:30 p.m.

MIDWEST

Monday-Friday: 8 a.m. to 4:30 p.m.

WEST COAST

Monday-Friday: 8 a.m. to 4:30 p.m.

/analyticallabgroup

/company/analyticallabgroup

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