Microbial Focus
Designed specifically for microbial biologics programs
Purpose-Built Biologics Manufacturing for FIH Programs
The AES Biologics facility supports microbial biologics from process development through first-in-human clinical manufacturing, with a focus on speed, flexibility, and risk reduction.
What This Facility is Designed to Do
AES Biologics operates U.S.-based biologics manufacturing facility focused on biotech companies navigating early clinical milestones.
Its design supports microbial biologics programs that require disciplined execution, GMP-compliant operations, and the ability to evolve as development progresses.
Capacity & Scale & At Glance
The AES Biologics facility is sized and configured to support early-stage and first-in-human programs while maintaining the rigor required for clinical manufacturing.
Scale up to 500L and 3,000 L Working Volume
Pilot-scale fermentation aligned to early clinical supply needs
GMP-Compliant Manufacturing
Facility infrastructure supports production of clinical-grade drug substance
Concurrent Program Support
Capacity designed to support multiple client programs in parallel
Analytical & QC Lab
Lab infrastructure supporting method development, characterization, and analytical activities for early clinical programs.
Process Development
Dedicated spaces for upstream and downstream process optimization and scale-down models.
Pilot GMP Manufacturing
Microbial fermentation and downstream process suites to deliver GMP clinical-grade material.
Integrated Support & Utilities
Media and buffer prep, stainless steel and single-use systems, and supporting infrastructure designed for reliable, reproducible results.
Core Facility Capabilities
Designed to Reduce Early-Stage Risk
Early-stage programs carry disproportionate technical and regulatory risk. AES Biologics addresses this by embedding risk-reduction principles directly into the facility's design and operation.
Risk-Reduction by Design Includes:
- Standardized Workflows
- Automation-Enabled Systems
- Engineering Discipline
- Early Scientific & Operational Oversight
Together, these principles support right-first-time execution and allow clients to advance their programs with confidence while maintaining momentum toward critical clinical milestones.
Transparency & Collaboration by Design
Clear Program Ownership
Defined accountability and experienced oversight throughout the program lifecycle.
Structured Communication Cadence
Predictable updates and decision points that keep clients informed and aligned.
Early Issue Visibility
Challenges are surfaced, communicated, and addressed promptly to support informed decision-making
Flexibility for Today, Headroom for Tomorrow
The facility was designed with phased growth in mind, allowing capacity to expand alongside client needs.
Modular design principles, adaptable infrastructure, and deep engineering expertise provide flexibility to accommodate evolving processes, scale up when needed, and emerging modalities over time—without sacrificing operational discipline.
Location & Strategic Advantage
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Located in the San Diego biotech ecosystem, the AES Biologics facility benefits from access to experienced talent, established supply chains, and a mature regulatory environment.
As part of the broader AES organization, the facility is supported by engineering, automation, and operational expertise—extending capabilities beyond the physical site itself.
Let’s Talk About Your Program
AES Biologics is redefining biologics manufacturing—combining scientific discipline, regulatory expertise, engineering precision, and operational excellence to bring tomorrow’s therapies to life.