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
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
PHYSIO-CHEMICAL
Chromatography
OUTSOURCED METHODS
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.
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.
