Introduction Pharmaceutical sponsors can execute a Switch CDMO After ANDA Submission, but the regulatory approach depends on whether the ANDA […]
Can You Switch CDMOs After an ANDA Has Been Submitted to the FDA? Read More »
Introduction Analytical Method Development and Impurity Profiling for complex cyclic peptide active pharmaceutical ingredients (APIs) establishes the analytical foundation necessary
Introduction: Peptide-oligonucleotide conjugate (POC) developers face a question that shapes every downstream decision — from IND strategy to exclusivity planning:
Are Peptide-Oligonucleotide Conjugates Regulated as Small Molecules or Biologics? Read More »
Introduction Optimizing Linker Hydrolytic Stability is a foundational chemical strategy for preventing premature payload dissociation during systemic circulation while still
Introduction An Abbreviated New Drug Application (ANDA) submission requires stability data from a minimum of three primary exhibit batches, which
Introduction Choosing an appropriate Good Manufacturing Practice (GMP) manufacturing partner for custom peptide synthesis services requires a detailed assessment of
Custom Peptide Synthesis Services: What to Look for in a GMP Manufacturing Partner Read More »
Introduction: CDMO support for ANDS can provide generic drug sponsors with the scientific, analytical, manufacturing, and documentation capabilities needed to
How CDMOs Support Abbreviated New Drug Submission (ANDS) for Health Canada Approval Read More »
Introduction Achieving an efficient EU Generic Drug Dossier Development and EMA Submission through a Canadian Contract Development and Manufacturing Organization
Introduction Charge Variant Analysis of Therapeutic Peptides is a critical analytical framework for profiling, quantifying, and monitoring charged proteoforms and
Introduction Peptide-Oligonucleotide Conjugate Sequence Confirmation Strategies integrate multi-stage tandem mass spectrometry (MS/MS) with targeted enzymatic digestion to achieve comprehensive primary
