Expertise at every step
State-of-the-art technology. Cutting-edge science. End-to-end services.
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Expertise at every step
State-of-the-art technology. Cutting-edge science. End-to-end services.
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Expertise at every step
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Expertise at every step
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Fully integrated drug development, manufacturing & testing
We are a US-based CDMO driven by the belief that scientific expertise and manufacturing excellence combined can bring innovative therapeutics to patients who need them. Our team of industry experts applies its broad experience with the sterile injectable dosage form in support of a diverse range of client projects. Our comprehensive portfolio of capabilities from lab-scale development through commercial manufacturing ensures quality, scalability and efficiency at every stage.
Headline and Text and Separator
Fully integrated drug development, manufacturing & testing
We are a US-based CDMO driven by the belief that scientific expertise and manufacturing excellence combined can bring innovative therapeutics to patients who need them. Our team of industry experts applies its broad experience with the sterile injectable dosage form in support of a diverse range of client projects. Our comprehensive portfolio of capabilities from lab-scale development through commercial manufacturing ensures quality, scalability and efficiency at every stage.
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Comprehensive service portfolio serving a broad range of customer requirements
- High-complexity formulations and processes
- Small, medium, and large-scale filling
- Wide variety of container types, sizes, and fill volumes
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Analytical chemistry
- High-complexity formulations and processes
- Small, medium, and large-scale filling
- Wide variety of container types, sizes, and fill volumes
Comprehensive service portfolio serving a broad range of customer requirements
Section Image Caption Left and Headline
Fully integrated drug development, manufacturing & testing
We are a US-based CDMO driven by the belief that scientific expertise and manufacturing excellence combined can bring innovative therapeutics to patients who need them. Our team of industry experts applies its broad experience with the sterile injectable dosage form in support of a diverse range of client projects. Our comprehensive portfolio of capabilities from lab-scale development through commercial manufacturing ensures quality, scalability and efficiency at every stage.
Comprehensive service portfolio serving a broad range of customer requirements
- High-complexity formulations and processes
- Small, medium, and large-scale filling
- Wide variety of container types, sizes, and fill volumes
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Advanced technology, collaborative approach
We have invested in state-of-the-art facilities and equipment to ensure delivery of the highest quality sterile injectable products. Our team focuses on building collaborative relationships with our clients, while leveraging our subject matter expertise to deliver a seamless experience from process development through distribution.
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Quality by Design
We systematically and proactively incorporate quality into the product from the start.
Our scientifically grounded, risk-based approach helps to ensure a robust final product that meets or exceeds global regulatory requirements and ICH standards.
Link to: Product Development – new
Product Development
Onsite development and testing laboratories led by highly experienced scientists.
- Process development and optimization
- DoE and QbD study design, execution, and statistical analysis
- Technology transfer and scale-up
Analytical Services
Advanced characterization and leading-edge technology
- Analytical method development and validation
- Full raw material release and USP <1> injectable testing for finished goods
- Stability testing across all ICH Zones for impermeable and semi-permeable containers
- Testing for residual solvents, elemental impurities, extractables & leachables, photostability, nitrosamines and container closure integrity, nitrosamines and thermal cycling
Manufacturing Services
Advanced sterile filling systems to support diverse container types and batch sizes
- Formulation scale of 1 L to 4000 L using stainless steel and single-use technology
- Fully isolated filling lines for vials, syringes and IV bags, including drug-device combination products
- Automated visual inspection, assembly, labeling, packaging, and serialization
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Manufacturing Services
Advanced sterile filling systems to support diverse container types and batch sizes
- Formulation scale of 1 L to 4000 L using stainless steel and single-use technology
- Fully isolated filling lines for vials, syringes and IV bags, including drug-device combination products
- Automated visual inspection, assembly, labeling, packaging, and serialization
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Explore our end-to-end capabilities
We serve our clients, at any phase, from early development through commercial-scale manufacturing. At every step, our technical experts work in partnership with our clients to optimize processes and advance programs into clinical or commercial manufacturing.
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Quality by Design
We systematically and proactively incorporate quality into the product from the start.
Our scientifically grounded, risk-based approach helps to ensure a robust final product that meets or exceeds global regulatory requirements and ICH standards.
Link to: Product Development – new
Product Development
Onsite development and testing laboratories led by highly experienced scientists.
- Process development and optimization
- DoE and QbD study design, execution, and statistical analysis
- Technology transfer and scale-up
Analytical Services
Advanced characterization and leading-edge technology
- Analytical method development and validation
- Full raw material release and USP <1> injectable testing for finished goods
- Stability testing across all ICH Zones for impermeable and semi-permeable containers
- Testing for residual solvents, elemental impurities, extractables & leachables, photostability, nitrosamines and container closure integrity, nitrosamines and thermal cycling
Accordion
Modalities
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- Biologics
- Schedule III-V controlled substances
- Lipid nanoparticles
Formulation development and optimization
Our technical staff works to incorporate QbD principles into the product development process for sterile injectables. We are focused on proactively mitigating potential risks with the product formulation, process, container closure system and packaging prior to GMP manufacturing
Pilot-scale filling
Our technical staff works to incorporate QbD principles into the product development process for sterile injectables.
- We are focused on proactively mitigating potential risks with the product formulation,
- Process
- Container closure system and packaging prior to GMP manufacturing
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Product characterization and optimization
Product characterization and optimization
- Target product profile (TPP) development
- Target product profile (TPP) development
- Target product profile (TPP) development
- Target product profile (TPP) development
- Target product profile (TPP) development
- Target product profile (TPP) development
- Target product profile (TPP) development
- Target product profile (TPP) development
Science that scales, development that supports manufacturing
Additional Section
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Advanced product characterization
Elemental impury testing
Analytical chemistry
- High-complexity formulations and processes
- Small, medium, and large-scale filling
- Wide variety of container types, sizes, and fill volumes
Content Slider Right Image
Analytical chemistry
- High-complexity formulations and processes
- Small, medium, and large-scale filling
- Wide variety of container types, sizes, and fill volumes
Advanced product characterization
Elemental impury testing
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- All ICH conditions for both impermeable and semi-permeable containers
- In-use stability, photostability, and compatibility studies
- Thermal cycling, freeze-thaw, and distribution studies
- Clinical, registration, and commercial stability
- Statistical modeling and shelf-life assignment
Pills Columns Small Container
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Single-use formulation
- 20 L to 1000 L capacity
- High-performance, rapid and low shear mixing
- Sterile, ready-to-use product contact surfaces
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Single-use formulation
- 20 L to 1000 L capacity
- High-performance, rapid and low shear mixing
- Sterile, ready-to-use product contact surfaces
Pills Columns Large Container
Follow a manual added link
Single-use formulation
- 20 L to 1000 L capacity
- High-performance, rapid and low shear mixing
- Sterile, ready-to-use product contact surfaces
Follow a manual added link
Single-use formulation
- 20 L to 1000 L capacity
- High-performance, rapid and low shear mixing
- Sterile, ready-to-use product contact surfaces
Follow a manual added link
Single-use formulation
- 20 L to 1000 L capacity
- High-performance, rapid and low shear mixing
- Sterile, ready-to-use product contact surfaces
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See also:
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Product Development
- Process development and optimization
- DoE and QbD study design, execution, and statistical analysis
- Technology transfer and scale-up
Overlap Section
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Research & Development
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Research & Development
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Research & Development
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Leveraging Expertise to Deliver Tailored Solutions
Our in-house teams are comprised of a diverse group of highly skilled experts whose combined experience ensures exceptional quality for our customers. Our team collaborates with our customers, providing innovative solutions that are specific to the requirements of their programs. From rigorous analytical testing to unique container solutions, our integrated teams leverage their deep knowledge and collaborative approach to drive excellence in every aspect of drug development and manufacturing.
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Join the growing August Bio team
At August Bio, you’ll have the opportunity to make a meaningful impact and improve patients’ lives while being part of a team dedicated to your success and growth. Take the next steps in building a rewarding career by directly contributing to our mission.
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Leadership Card
Chief Executive Officer
Over 30 years in the industry
- Healthcare Executive with extensive experience providing strategic and operational leadership for both large public corporations and private growth-stage companies
- Deep domain expertise in sterile injectable pharmaceutical development, manufacturing, and commercialization
- Expert at building high performing teams; advocate for patient safety, scientific discovery, and healthcare innovation
Parenteral Perspectives
Exploring innovations, challenges, and future horizons in parenteral drug delivery.
CDMOs: Key Leader Insights
For this roundtable, Contract Pharma called upon thought leaders across the pharmaceutical services sector to address “3 Key Trends” impacting the CDMO industry in 2025 and beyond.
Development to Delivery: A CDMO’s Guide to Strategic Scale-Up
Bringing a sterile injectable product from development to commercialization requires a seamless scale-up process—one that minimizes risk, optimizes efficiency, and ensures regulatory success. In this exclusive webinar, experts from August Bioservices will discuss the critical factors that make or break a successful scale-up, sharing insights from a CDMO’s unique perspective.