Oral Peptide Drug Products: Permeation Enhancers, SNAC, and What They Mean for Manufacturing
Introduction Oral Peptide Drug Products rely on advanced permeation enhancers such as salcaprozate sodium (SNAC) to protect macromolecular payloads from […]
Cyclic, Stapled, and Constrained Peptides: Synthesis Routes and Analytical Challenges
Introduction Cyclic, Stapled, and Constrained Peptides have emerged as an important paradigm in contemporary drug discovery because they combine high
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Lipidated and Long-Acting Peptides: Fatty-Acid Acylation, PEGylation, and Their Manufacturing Impact
Introduction Lipidated and long-acting peptides employ hydrophobic acyl chains or polymer conjugates to prolong systemic circulation half-lives from only a
Green Chemistry in Peptide Manufacturing: Replacing DMF, Cutting Solvent Waste, and Improving PMI
Introduction Green Chemistry in Peptide Manufacturing offers a strategic approach to addressing the significant environmental, occupational, and economic challenges associated
Controlling Epimerization and Aspartimide Formation During Solid-Phase Peptide Synthesis
Introduction Controlling Epimerization and Aspartimide Formation during solid-phase peptide synthesis (SPPS) is essential for producing high-purity therapeutic peptides and preventing
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TFA Counterion Exchange and Salt Form Selection in Peptide API Manufacturing
Introduction TFA Counterion Exchange and Salt Form Selection is a critical downstream unit operation in active pharmaceutical ingredient (API) manufacturing
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Extractables and Leachables Testing for Peptide Injectables: Syringes, Stoppers, and Single-Use Systems
Introduction Extractables and Leachables Testing for Peptide Injectables is an essential analytical prerequisite for assessing the chemical compatibility, physical stability,
Nitrosamine Risk Assessment for Peptide APIs and Drug Products: Where NDSRIs Actually Come From
Introduction A comprehensive Nitrosamine Risk Assessment for Peptide APIs examines the specific chemical pathways through which reactive secondary and tertiary
Peptide Drug Master File (DMF) Preparation and Filing Support
Introduction Peptide Drug Master File (DMF) Preparation requires the development of a comprehensive Chemistry, Manufacturing, and Controls (CMC) technical dossier
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North American Peptide CDMO Services: Why Sponsors Are Reshoring Peptide API Supply
Introduction Biopharmaceutical sponsors are increasingly reshoring active pharmaceutical ingredient (API) manufacturing through North American Peptide CDMO Services to address critical
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