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Helping Innovators Develop High-Value Proteins, Peptides & Enzymes

AES Biologics partners with biotech teams developing recombinant proteins, peptides, and enzymes—including programs at various stages of development facing expression challenges, tight timelines, or evolving regulatory needs.

Discuss Your Program
Learn About our Capabilities
Scientist in a lab coat and gloves drawing liquid into a syringe from a bioreactor vessel with tubing and stainless steel fittings, conducting microbial process development in a laboratory setting.

Who We Serve

We develop analytical methods using phase-appropriate standards to support in-process and release testing, ensuring quality and regulatory alignment as programs advance.

Emerging Biopharma

AES Biologics supports clinical-stage innovators advancing recombinant proteins, peptides, and enzymes that need:

  • Efficient, high-fidelity tech transfer
  • Support optimizing upstream and purification strategies
  • Clinical Trial Material and data enabling regulatory submissions
  • A scientific partner who provides hands-on, collaborative guidance

Growing Biotechs with Specialized Needs

Ideal for teams with complex development challenges requiring:

  • Expertise in overcoming expression, solubility, or folding issues
  • Refolding strategies for difficult proteins
  • Flexible timelines without large CDMO delays
  • Engineering-based problem solving

Teams requiring GMP Drug Substance and Reliable Reference Standards

We support teams needing:

  • Purified, aliquoted, and qualified reference standards
  • Non-GMP and GMP Drug Substance
  • Controlled, semi-automated vial filling to minimize contamination risk
  • Stability and characterization supporting assay readiness

What We Support

Molecular clusters in a microscopic world

AES Biologics currently focuses on microbial programs involving:

  • Therapeutic proteins
  • Recombinant enzymes
  • Novel or engineering proteins
  • Difficult to express proteins
  • PEGylated proteins (depending on workflow and feasibility)
  • Extracellular, intracellular, periplasmic, and inclusion body expressions
Inclusion Body Formation & Refolding

Proteins that express but do not fold correctly.

How we help: Structured refolding workflows and upstream optimization strategies

Slow or Rigid Timelines

Large CDMOs often deprioritize early programs, resulting in costly delays.

How we help: Faster, more responsive tech transfer

Reference Standard Quality Issues

Variability affecting assay reliability

How we help: Purified, aliquoted, and qualified reference standards with semi-automated filling.

Regulatory Pressure

Pre-clinical and Clinical-stage teams navigating evolving expectations

How we help: Phase-appropriate documentation and filing support aligned with FDA/EMA requirements.

Challenges We Specialize in Solving

How We Help

  • Tech Transfer and gap assessment
  • Process mapping and risk identification
  • Method and data alignment
  • Operational requirements defined for faster start-up
  • Strain development and engineering
  • Multi-feed strategies
  • Inclusion body evaluation
  • DoE-supported optimization
  • Online dilution
  • Cell harvest with separator
  • Homogenization and clarification strategies
  • Chromatography development
  • Refolding workflows
  • Filtration and polishing operations
  • Purification and formulation of reference standards
  • Semi-automated vial filling
  • Stability studies across temperature and pH levels
  • Analytical method alignment and readiness

Ready to Advance Your Program?

Tell us about your program so we can connect yout with a technical expert today.

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