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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