Description
August Bioservices is a US-based, quality-driven Contract Development and Manufacturing Organization (CDMO) that provides comprehensive drug research and development, cGMP laboratory services, and sterile fill/finish cGMP manufacturing. Catering to clients of all sizes and stages, from pre-clinical to commercial, August Bioservices offers a unique one-stop-shop approach with a focus on sterile injectables, high-complexity formulations, poorly soluble and highly viscous compounds, as well as uncommon container sizes and fill volumes. The company has recently expanded its facilities, adding multiple high-speed filling lines and a new aseptic IV bag filler, reinforcing its commitment to supporting clients throughout the drug product lifecycle.
Services include:
– 505(b)(2)
– Accelerated Stability Studies
– Analytical Services
– Animal Health
– Aseptic Fill/Finish
– Assay Development
– Barcoding
– Clinical Supply Management
– Chemistry (CMC)
– Manufacturing
– Sourcing
– Contaminant Analysis
– Contract Development and Manufacturing (CDMO)
– Contract Manufacturing (CMO)
– Contract Packaging
– Custom Manufacturing
– Distribution
– Clinical Trials
– Dosage Form Development
– Drug Delivery Devices
– Drug Design
– Drug Development
– Contract Development
– Testing
– Filling
– Syringe
– Vials
– Forced Degradation Studies
– Process Development
– Formulation Development
– Chromatography
– Supply Chain & Logistics
– Lot Release Testing
– Lyophilization
– Clinical Trial Materials
– Creams & Ointments
– Dose Form
– Sterile
– Gels
– Generics
– Injectables
– Liquids
– Parenterals
– Large Volume
– Small Volume
– Semisolids
– Solutions & Suspensions
– Pre-filled
– Topicals
– Mass Spectrometry
– Microbiological Testing
– Microencapsulation
– Micronization
– Mixing & Blending
– Packaging
– Anti-Counterfeiting
– Closures
– Compliance
– Asceptic Fill-Finish
– Glass
– Labelling
– Samples
– Unit Dosage
– Parenterals Development
– Particle Characterization
– Particle Size Analysis
– Particle Size Classification
– Pilot-Scale Filling
– Preclinical Study Design
– Preclinical Testing Formulations
– Preformulation
– Process Characterization
– Process R&D
– Process Validation Studies
– Project Management
– Quality QA/QC
– R&D Services
– Scale-Up
– Serialization
– Size Reduction
– Stability Studies
– Stability
– ICH
– Statistical Analysis
– Sterile Filling
– Sterility Testing
– Sterilization
– Storage
– Target Profiling
– Technology Transfer
– Validation
– Clinical
– Filtration
– Warehousing
– Packaging Equipment
– Regulatory Services
– Non Sterile Dosage
– Clinical Dose
– Clinical Packaging
As a growing leader in the pharmaceutical industry, August Bioservices is dedicated to delivering high-quality services throughout the drug development process. For more information, please visit augustbio.com.
Capabilities
- Accelerated Stability Studies
- Analytical Services
- Animal Health
- Anti-Counterfeiting
- Asceptic Fill-Finish
- Assay Development
- Barcoding
- Chemistry (CMC)
- Chromatography
- Clinical
- Clinical Dose
- Clinical Packaging
- Clinical Trial Materials
- Clinical Trials
- Closures
- Compliance
- Contaminant Analysis
- Contract Development
- Contract Development and Manufacturing (CDMO)
- Contract Packaging
- Creams & Ointments
- Custom Manufacturing
- Dosage Form Development
- Dose Form
- Drug Delivery Devices
- Drug Development
- Filling
- Filtration
- Forced Degradation Studies
- Formulation Development
- Gels
- Generics
- Glass
- ICH
- Injectables
- Labelling
- Large Volume
- Liquids
- Lot Release Testing
- Lyophilization
- Mass Spectrometry
- Microbiological Testing
- Microencapsulation
- Micronization
- Mixing & Blending
- Non Sterile Dosage
- Packaging
- Packaging Equipment
- Parenterals
- Parenterals Development
- Particle Size Analysis
- Pilot-Scale Filling
- Preclinical Study Design
- Preclinical Testing
- Preformulation
- Process Characterization
- Process Development
- Process Validation Studies
- Project Management
- Quality QA/QC
- Regulatory Services
- Research & Development
- Samples
- Scale-Up
- Semisolids
- Serialization
- Size Reduction
- Solutions & Suspensions
- Sourcing
- Stability Studies
- Statistical Analysis
- Sterile
- Sterile Filling
- Sterility Testing
- Sterilization
- Storage
- Supply Chain & Logistics
- Syringe
- Target Profiling
- Technology Transfer
- Testing
- Topicals
- Unit Dosage
- Validation
- Vials
- Warehousing
Contact Information
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