Immunogenicity risk assessment of synthetic peptide drugs and their impurities

Author:

De Groot Anne S,Roberts Brian J,Mattei Aimee,Lelias Sandra,Boyle Christine,Martin William D

Publisher

Elsevier BV

Subject

Drug Discovery,Pharmacology

Reference102 articles.

1. Prices of Generic Drugs Associated with Numbers of Manufacturers;Dave;N Engl J Med,2017

2. In silico immunogenicity assessment for sequences containing unnatural amino acids: A method using existing in silico algorithm infrastructure and a vision for future enhancements;Mattei;Front Drug Discov,2022

3. CDER. ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry Guidance for Industry. FDA-2017-D-5767. Published online May 2021. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/andas-certain-highly-purified-synthetic-peptide-drug-products-refer-listed-drugs-rdna-origin.

4. Influence of Production Process and Scale on Quality of Polypeptide Drugs: a Case Study on GLP-1 Analogs;Staby;Pharm Res,2020

5. CDER/FDA. ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. Docket Number: FDA-2017-D-5767

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