We develop analytical methods using phase-appropriate standards to support in-process and release testing, ensuring quality and regulatory alignment as programs advance.
AES Biologics supports clinical-stage innovators advancing recombinant proteins, peptides, and enzymes that need:
Ideal for teams with complex development challenges requiring:
We support teams needing:
Experienced scientists and engineers—including alumni from Genentech—bring strong bioprocess, analytical, and automation expertise to every program.
Tailored approach for preclinical, IND-enabling, and early clinical milestones.
Robust quality systems support consistent development and manufacturing performance.
Seasoned GMP, quality, and regulatory experts help advance programs toward IND and early clinical readiness.
Domestic scientific, operational, and quality oversight to support accelerated timelines, seamless collaboration, and supply chain resilience.
Process automation, data systems, and engineering rigor strengthen reproducibility across the development and manufacturing lifecycle
As part of the AES network, AES Biologics is built on decades of experience in process engineering, automation, data systems, staffing, and GMP facility readiness.
This foundation enables technical depth, digital oversight, and operational discipline uncommon among emerging CDMOs.
AES Biologics delivers phase-appropriate development and manufacturing solutions tailored to early-stage biopharma programs. Our multidisciplinary scientific and engineering teams help clients advance from foundational research to IND-enabling readiness and beyond.
We work as an extension of each client’s team, maintaining transparent communication, scientific alignment, and shared ownership of program outcomes.
Our approach integrates:
We support your molecule early to ensure a seamless path in clinical and commercial manufacturing.
A clear, structured path from program assessment to early clinical execution.
Our analytical laboratory provides the rigor and method robustness required to support characterization, release readiness, and clinical advancement.
Services include:
Our analytical frameworks are built to support regulatory clarity and early-phase submission readiness.
We design and optimize microbial expression systems and purification workflows to ensure reproducibility, process robustness, and efficient scale-up.
Services include:
This ensures scalable, reproducible performance as your program advances through clinical manufacturing.
Our microbial manufacturing capabilities deliver controlled, reliable execution for early clinical programs with strong quality oversight.
Services include:
Our manufacturing operations follow disciplined GMP practices and quality systems aligned with early clinical expectations.
AES Biologics is structured around three primary capabilities spanning analytical development, process development, and clinical manufacturing. Each area includes specialized services designed to advance biologics programs with consistency and confidence.
Our approach emphasizes structured, engineering-led tech transfer to ensure consistency, reproducibility, and efficient progression into manufacturing.
AES Biologics integrates analytical, process development, manufacturing, and engineering expertise into a unified approach that reduces variability, strengthens process fidelity, and supports reliable scale-up into clinical programs
AES Biologics operates development and manufacturing infrastructure built around quality, automation, data integrity and phase-appropriate execution for early clinical programs.
Our systems and controls are designed to support compliance-ready execution as client programs advance.
Learn more about the AES Biologics facility.
AES Biologics brings scientific depth, engineering precision, and regulatory compliance to support the advancement of early-stage biologics programs.
Share a few details about your program, and our team will follow up to discuss feasibility, timelines, and next steps.
