[HTML][HTML] Advances in Therapeutic Peptides Separation and Purification

O Al Musaimi, DMM Jaradat - Separations, 2024 - mdpi.com
Peptides are gaining prominence in various fields, including the pharmaceutical industry. To
meet regulatory requirements, they must achieve a certain purity threshold to ensure safe …

Impact of Impurities on the Quality and Safety of Oligonucleotides as Drug Substances

J Kaufmann, TM Rupp - 2024 - books.rsc.org
This chapter covers chemistry, manufacturing, and controls (CMC) aspects based on the
quality vision of synthetically manufactured oligonucleotides as active pharmaceutical …

Oligopeptide Regulatory Affairs and Challenges

AJ Wolf, A Ricci - 2024 - books.rsc.org
In the USA, drugs and biologics are regulated under different regulatory pathways. Drugs
are approved under the Food and Drug and Cosmetic Act and the Food and Drug …