Introduction Contract development and manufacturing organizations (CDMOs) that initially specialized in synthetic peptides have expanded their capabilities into nucleic acid […]
Introduction Evaluating COC and COP containers as glass alternatives highlights an advanced primary packaging strategy for sensitive biologics, parenteral formulations,
COC and COP Containers as Glass Alternatives: What Their Extractables Profiles Reveal Read More »
Introduction Uncontrolled migration of non-bonded plasticizers and the sorption of therapeutic drugs remain two major material-compatibility challenges associated with polyvinyl
Introduction: Sterilization changes an extractables and leachables profile because heat, radiation, or reactive gas alters the polymers, additives, and residues
Introduction Establishing robust Oligonucleotide CMC Specifications requires addressing unique regulatory challenges because therapeutic oligonucleotides possess physical, chemical, and structural characteristics
Introduction Phosphorothioate diastereomers present significant challenges in oligonucleotide characterization. This is because replacing a non-bridging oxygen atom in the phosphodiester
Introduction Antioxidant extractables in pharmaceutical polymers comprise low-molecular-weight parent stabilizers, such as Irganox 1010 and Irgafos 168, along with their
Introduction: Nitrite Quantification in Pharmaceutical Excipients is the analytical measurement of trace nitrite (NO₂⁻) in the inactive ingredients of a
Introduction Native Chemical Ligation provides a chemo- and regioselective chemical approach for joining unprotected synthetic peptide segments to produce full-length
Native Chemical Ligation: Building Small Proteins From Synthetic Peptide Fragments Read More »
Introduction Raw Material Characterization Before Extractable & Leachable Testing is essential for establishing an accurate chemical baseline, identifying thermal transition
