Manufacturing processes of peanut (Arachis hypogaea) allergen powder-dnfp

ABSTRACT:

Background

Important components of drug safety, efficacy, and acceptability involve manufacturing and testing of the drug substance and drug product. Peanut flour sourcing/processing and manufacturing processes may affect final drug product allergen potency and contamination level, possibly impacting drug safety, quality, and efficacy. We describe key steps in the manufacturing processes of peanut (Arachis hypogaea) allergen powder-dnfp (PTAH; Palforzia®), a drug used in oral immunotherapy (OIT) for the treatment of peanut allergy.

Methods

Established criteria for source material must be met for manufacturing PTAH drug product. Degree of roasting was determined with a Hunter colorimeter. Protein/allergen content, identity, potency, safety, and quality of each batch of PTA

SUBMITTER: Leonard S 

PROVIDER: S-EPMC9592818 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature