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. 


Our Clinical/Regulatory team provides support and assistance with clinical development, clinical operations, and regulatory submissions to the FDA and international regulatory agencies, ensuring collaborator products efficiently enter human clinical trials.

GMP Virtual Tour

Capabilities

  • Manufacturing of liquid, emulsion, nanoparticle, and liposomal formulations for pre-clinical and clinical use.
  • 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.

gmp grade nlc rna complexed material

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)

PHYSIO-CHEMICAL

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

Chromatography

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

OUTSOURCED METHODS

  • Sterility
  • Bioburden
  • Microbial Limits Testing
  • Endotoxin
  • Pyrogenicity
  • Particulate Matter
  • Mass Spectrometry
outside of gmp suite

CLINICAL/REGULATORY

CONSULTING SERVICES

We provide assistance with FDA and other regulatory agency submissions and clinical trial support to ensure your product in combination with AAHI technology, can efficiently enter human clinical trials.

  • Support regulatory strategy decisions and prepare submissions for obtaining regulatory and ethical approval for clinical trials in the U.S. and offshore.
  • Maintain 10 Biological Master Files for our robust adjuvant portfolio, allowing collaborators to easily cross-reference this information in their INDs.
  • Support management of all aspects of clinical development and operations.

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.

female scientists