100+ FDA Inspections Supported
We’ve supported high-stakes regulatory milestones across global biologics programs
About AES Biologics
Engineering the Next Generation of Biologic Manufacturing
AES Biologics is an independently operating contract manufacturing organization (CMO) powered by the engineering, automation, scientific, and regulatory expertise of Automated Engineering Services, Inc. (AES).
We help biotechnology innovators reduce development timelines, cost, and risk by integrating automation, process control, data systems, and compliance-ready frameworks early in the development cycle—bridging the gap between scientific discovery and GMP readiness.
Our Mission
Transforming Biologic Innovation into Scalable Manufacturing
AES Biologics helps biotechnology innovators translate promising science into manufacturable, compliant therapeutics—faster with greater technical and regulatory control. We partner with emerging biopharma companies developing novel and complex therapies, specializing in pre-clinical and first-in-human (FIH) programs.
Our U.S.-based, GMP-aligned manufacturing solutions are designed for speed, flexibility, and process understanding—helping clients demonstrate clinical readiness, regulatory preparedness, and achieve critical investor milestones.
Our Vision
Building a Next-Generation Biologics Contract Manufacturing Organization
Our vision is to create a biologics CMO where engineering precision, automation, scientific collaboration, and regulatory expertise converge—delivering efficient, data-driven pathways from early development through commercialization.
AES Biologics is built for long-term adaptability, with capabilities that expand as client needs evolve. Our growth roadmap includes emerging modalities such as live biotherapeutics (LBPs) and plasmid DNA (pDNA) supply, reinforcing our commitment to next-generation biomanufacturing.
Scientific & Regulatory Expertise
Proven Experience Across FDA, Global Agencies, and Complex Biologic
Programs
AES Biologics is built on a foundation of more than 100 combined years of scientific, GMP, regulatory, and operational experience across biologics manufacturing, clinical production, and commercial facility readiness.
Regulatory Approvals Across Continents
FDA, EMA, and global agencie—from early submission through commercial readiness
Clinical-to-Commercial Transitions
Guilding complex biologics from development through full-scale GMP execution
Engineering-Led Capabilities
Technical, regulatory, and operational execution built on engineering precision and process control.
Muli-Modality Tech Transfer
Seamless transfer from development into GMP-aligned production environments
Regulatory Inspection Leadership
Experienced guidance through FDA inspections and high-stakes regulatory interactions, ensuring preparedness, documentation integrity, and confident execution
BLA & Global Submissions
Support for BLA approvals and international regulatory filings aligned with FDA, EMA, and global health authority expectations
GMP Operations & Quality Systems
Design and implementation of GMP operations, structured quality systems, and QA lot release frameworks built for regulatory scrutiny
Clinical-to-Commercial Scale-Up
Strategic scale-up of complex biologic programs from early development through validated commercial manufacturing readiness
Regulatory Affairs & Audit Readiness
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A Foundation Built on Engineering Excellence
As part of the AES family, AES Biologics extends decades of experience in process engineering, automation, data management, staffing, facility qualification, and GMP readiness into biologic manufacturing. Our foundation in engineering allows us to deploy digital systems, process analytics, and validation methodologies typically found only in large-scale CDMOs—within a nimble framework optimized for innovators at every stage of development.
AES Biologics extends the AES solution—uniting engineering, automation, data, staffing, and regulatory alignment to provide end-to-end biotech solutions. This integration ensures continuity, scalability, and compliance across the AES network, from process design and integration to GMP execution and operational support.
Our Approach
A Disciplined, Data-Driven Partnership Model
Every molecule represents years of research and patient impact. AES Biologics applies structured engineering and scientific rigor to every program through:
We recognize that each molecule represents years of innovation, investment, and hope, which is why we approach every partnership with that same level of care and ownership
Quality First
Ensuring GMP alignment, QA lot release readiness, and robust quality systems that support regulatory expectations from the first batch
Speed & Precision
Compressing development timelines through optimized workflows.
Transparency & Reliability
Maintaining clear communication, accountability, and regulatory clarity at every milestone.
Technical Depth
Leveraging multidisciplinary expertise in bioprocessing, controls, quality systems, and regulatory strategy.
Collaborative Execution
Aligning scientific and engineering teams to advance client goals.
Why AES Biologics
Redefining Biologics Manufacturing Through Engineering, Science, and
Regulatory Excellence
AES Biologics integrates automation, process analytics, and digital oversight at every stage to
improve reproducibility, scalability, and regulatory readiness. Our engineering-centric,
science-driven philosophy reduces development risk, enhances process robustness, and
improves quality and efficiency from pilot to GMP manufacturing.
What Sets Us Apart
Data-Driven Execution
Every batch is monitored, recorded, and analyzed to ensure full process visibility.
Technical Rigor
Engineering precision and scientific oversight built into every phase of development.
Regulatory Readiness
Systems, documentation, and analytical structure aligned with FDA, EMA, and global expectations.
Agility & Partnership
A responsive, collaborative model built for innovators progressing toward first-in-human milestones.
Partner with AES Biologics
AES Biologics is redefining biologics manufacturing—combining scientific discipline, regulatory
expertise, engineering precision, and operational excellence to bring tomorrow’s therapies to
life.