Laboratory Services
The extensive capabilities of August Bio’s onsite cGMP analytical laboratories include
performing all requisite tests to measure both drug substance and drug product
quality for sterile injectables, semi-solids and non-sterile liquid products.
The goal of the August Bio team is to deliver the testing methods, execution,
data, and insights to support CMC submission readiness. A clear differentiator is
our Mass Spectrometry expertise and Extractables and Leachables programs.
Follow a manual added link
• All ICH conditions for both impermeable
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment and semi-permeable containers
compatibility studies
distribution studies ICH Stability Study
Design and Execution 
• Container closure systems, filters, and
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products single-use components
Screening
leachables of interest (or potential leachables) Extractable and Leachable
Study Design and Execution 
• Compendial and novel raw material
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing qualification Comprehensive Raw Material and
Finished Good Testing 
• Antimicrobial Efficacy
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content Microbiological Method Development,
Validation and Testing 
• Drug Substance and Drug Product
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from Chromatography with multiple detectors
clinical to commercial Analytical Method Development,
Validation and Testing 
• Screening
• Isolation
• Structural Elucidation
• Particle Size Analysis Advanced Small
Molecule Characterization
ICH Stability Study Design and Execution
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment
compatibility studies
distribution studies
Design and Execution
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products
Screening
leachables of interest (or potential leachables)
Study Design and Execution
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
Follow a manual added link• All ICH conditions for both impermeable
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment and semi-permeable containers
compatibility studies
distribution studies ICH Stability Study
Design and Execution • Container closure systems, filters, and
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products single-use components
Screening
leachables of interest (or potential leachables) Extractable and Leachable
Study Design and Execution • Compendial and novel raw material
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing qualification Comprehensive Raw Material and
Finished Good Testing • Antimicrobial Efficacy
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content Microbiological Method Development,
Validation and Testing • Drug Substance and Drug Product
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from Chromatography with multiple detectors
clinical to commercial Analytical Method Development,
Validation and Testing • Screening
• Isolation
• Structural Elucidation
• Particle Size Analysis Advanced Small
Molecule Characterization
Extractable and Leachable Study Design and Execution
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment
compatibility studies
distribution studies
Design and Execution
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products
Screening
leachables of interest (or potential leachables)
Study Design and Execution
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
Follow a manual added link• All ICH conditions for both impermeable
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment and semi-permeable containers
compatibility studies
distribution studies ICH Stability Study
Design and Execution • Container closure systems, filters, and
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products single-use components
Screening
leachables of interest (or potential leachables) Extractable and Leachable
Study Design and Execution • Compendial and novel raw material
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing qualification Comprehensive Raw Material and
Finished Good Testing • Antimicrobial Efficacy
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content Microbiological Method Development,
Validation and Testing • Drug Substance and Drug Product
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from Chromatography with multiple detectors
clinical to commercial Analytical Method Development,
Validation and Testing • Screening
• Isolation
• Structural Elucidation
• Particle Size Analysis Advanced Small
Molecule Characterization
Comprehensive Raw Material and Finished Good Testing
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment
compatibility studies
distribution studies
Design and Execution
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products
Screening
leachables of interest (or potential leachables)
Study Design and Execution
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
Follow a manual added link• All ICH conditions for both impermeable
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment and semi-permeable containers
compatibility studies
distribution studies ICH Stability Study
Design and Execution • Container closure systems, filters, and
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products single-use components
Screening
leachables of interest (or potential leachables) Extractable and Leachable
Study Design and Execution • Compendial and novel raw material
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing qualification Comprehensive Raw Material and
Finished Good Testing • Antimicrobial Efficacy
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content Microbiological Method Development,
Validation and Testing • Drug Substance and Drug Product
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from Chromatography with multiple detectors
clinical to commercial Analytical Method Development,
Validation and Testing • Screening
• Isolation
• Structural Elucidation
• Particle Size Analysis Advanced Small
Molecule Characterization
Microbiological Method Development, Validation and Testing
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment
compatibility studies
distribution studies
Design and Execution
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products
Screening
leachables of interest (or potential leachables)
Study Design and Execution
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
Follow a manual added link• All ICH conditions for both impermeable
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment and semi-permeable containers
compatibility studies
distribution studies ICH Stability Study
Design and Execution • Container closure systems, filters, and
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products single-use components
Screening
leachables of interest (or potential leachables) Extractable and Leachable
Study Design and Execution • Compendial and novel raw material
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing qualification Comprehensive Raw Material and
Finished Good Testing • Antimicrobial Efficacy
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content Microbiological Method Development,
Validation and Testing • Drug Substance and Drug Product
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from Chromatography with multiple detectors
clinical to commercial Analytical Method Development,
Validation and Testing • Screening
• Isolation
• Structural Elucidation
• Particle Size Analysis Advanced Small
Molecule Characterization
Analytical Method Development, Validation and Testing
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment
compatibility studies
distribution studies
Design and Execution
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products
Screening
leachables of interest (or potential leachables)
Study Design and Execution
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
Follow a manual added link• All ICH conditions for both impermeable
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment and semi-permeable containers
compatibility studies
distribution studies ICH Stability Study
Design and Execution • Container closure systems, filters, and
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products single-use components
Screening
leachables of interest (or potential leachables) Extractable and Leachable
Study Design and Execution • Compendial and novel raw material
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing qualification Comprehensive Raw Material and
Finished Good Testing • Antimicrobial Efficacy
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content Microbiological Method Development,
Validation and Testing • Drug Substance and Drug Product
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from Chromatography with multiple detectors
clinical to commercial Analytical Method Development,
Validation and Testing • Screening
• Isolation
• Structural Elucidation
• Particle Size Analysis Advanced Small
Molecule Characterization
Advanced Small Molecule Characterization
• In-use stability, photostability and
• Thermal cycling, freeze-thaw and
• Clinical, registration and commercial stability
• Statistical modeling and shelf-life assignment
compatibility studies
distribution studies
Design and Execution
• Non-volatile, semi-volatile and volatile
• Method development and validation for
• All routes of administration
• Medical Devices and Drug Products
Screening
leachables of interest (or potential leachables)
Study Design and Execution
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
