Manufacturing and Supply

AAHI performs formulation development, fill & finish services, and ICH compliant stability studies in its state-of-the-art labs and cGMP facilities located in Seattle’s South Lake Union neighborhood. Our formulation development services focus on liquid, emulsion, and liposome formulations.

GMP Virtual Tour

Capabilities

  • Pre-clinical to Phase 2 manufacturing
  • Pharmacology, toxicology and characterization studies, phase 1 and 2 clinical studies with a batch capacity of up to 1,200 vials of drug product in compliance with US and EU regulations

Stability Studies

We work with clients to execute their protocol, design a protocol, or mutually design the right stability study to accommodate any special needs associated with a client’s drug product.

The protocol specifies frequency of testing and storage conditions (temperatures, position); appropriate stability-indicating methods; and degradation products that may be stability limiting.

Analytical Methods

AAHI provides analytical development and quality control services to support formulation development, product release, and stability studies. Existing analytical methods can be applied for quantification, characterization, and identification of product. New methods may be developed and qualified, and existing compendial methods verified 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 need them most.