Manufacturing and Supply

AAHI’s state-of-the-art cGMP manufacturing facilities and highly qualified cGMP manufacturing team enable us to manufacture cGMP drug products (including vaccines and other biologics) and to provide fill & finish services, and ICH compliant stability studies. We focus on manufacture of research-grade and cGMP liquid, emulsion, nanoparticle, and liposomal formulations.

GMP Virtual Tour

Capabilities

  • Manufacturing for pre-clinical and clinical use through Phase 2 clinical trials.
  • Supply for Phase 1 and Phase 2 clinical studies in compliance with US and EU regulations, with a batch capacity of up to 1,200 vials of drug product.

Stability Studies

We work with clients to design stability studies or to execute existing stability protocols; we collaborate to accommodate special needs associated with a client’s drug product.

Our stability protocols specify frequency of testing and storage conditions (e.g., temperatures, position); appropriate stability indicators and methods; and degradation products that may limit stability.

Analytical Methods

AAHI provides analytical development and quality control services to support formulation development, manufacturing process development, cGMP product release, and stability studies. We apply existing analytical methods for quantification, characterization, and identification of drug product. We develop and qualify new methods and verify existing compendial methods as needed.

Biochemistry

  • Protein content (UV & BCA)
  • Electrophoresis (SDS-PAGE, Colloidal blue, Silver stain, Western Blotting, IEF)
  • Immunogenicity (ELISAs)

Chromatography

  • Gas chromatography for squalene quantitation and residual solvents
  • HPLC quantitation or characterization for Lipid A, phospholipids, oligonucleotides, and small molecules

Physio-Chemical

  • Appearance
  • pH
  • Osmolality
  • Particle size
  • Conductivity
  • Residual moisture

Outsourced Methods

  • Sterility
  • Bioburden
  • Microbial Limits Testing
  • Endotoxin
  • Pyrogenicity
  • Particulate Matter
  • Mass Spectrometry
  • FTIR
  • Other methods as necessary

AAHI Is All About Collaboration.

Our commitment to global equity permeates our efforts to forge collaborations and partnerships to make immunologic innovations equitably accessible to the people who most need them.