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.
ICH Stability Study Design and Execution
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-1.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-2.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-3.jpg)
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-4.jpg)
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-5.jpg)
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-6.jpg)
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
Extractable and Leachable Study Design and Execution
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-1.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-2.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-3.jpg)
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-4.jpg)
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-5.jpg)
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-6.jpg)
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
Comprehensive Raw Material and Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-1.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-2.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-3.jpg)
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-4.jpg)
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-5.jpg)
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-6.jpg)
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
Microbiological Method Development, Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-1.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-2.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-3.jpg)
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-4.jpg)
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-5.jpg)
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-6.jpg)
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
Analytical Method Development, Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-1.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-2.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-3.jpg)
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-4.jpg)
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-5.jpg)
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-6.jpg)
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
Advanced Small Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-1.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-2.jpg)
• 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
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-3.jpg)
• Sterile injectable product quality testing
• Topical product quality testing
• Oral Liquid product quality testing
Finished Good Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-4.jpg)
• Bioburden
• Endotoxin
• Sterility
• Container Closure Integrity
• Total Organic Content
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-5.jpg)
• Development, Optimization, and Bridging
• Verification, Validation, and Transfer
• Liquid Chromatography and Gas
• Submission ready validation packages from
clinical to commercial
Validation and Testing
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)
![](https://www.augustbio.com/wp-content/uploads/2022/03/ls-project-53-slide-6.jpg)
• Isolation
• Structural Elucidation
• Particle Size Analysis
Molecule Characterization
![](https://www.augustbio.com/wp-content/uploads/2022/03/btn_Next.png)