Small-Scale to Commercial: Can One US Peptide CDMO Scale With You?
Small-Scale to Commercial: Can One US Peptide CDMO Scale With You? Read More »
Method Validation for Leachables Testing: What Regulators Expect from a GMP Lab
Introduction Method Validation for Leachables Testing in a Good Manufacturing Practice (GMP) laboratory provides documented, objective evidence that an analytical
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What Is the Difference Between an Antisense Oligonucleotide and a Peptide-Oligonucleotide Conjugate?
Introduction: Anyone comparing an antisense oligonucleotide vs peptide-oligonucleotide conjugate is really asking a structural question: is the therapeutic molecule a
Audit-Ready Extractables and Leachables (E&L) Data: How a Drug Establishment Licence Testing Lab Protects Your Submission
Introduction Producing audit-ready Extractables and Leachables (E&L) data depends on a scientifically defensible, cGMP-compliant testing architecture capable of proving that
How to Choose a Peptide CDMO: A Sponsor’s Evaluation Checklist for Synthesis, Scale-Up, and Quality
Introduction How to Choose a Peptide CDMO? Sponsoring organizations must perform a comprehensive technical audit that assesses chemical synthesis platforms,
How Long Does Generic Drug Development Take at a CDMO? Timeline Expectations Explained
Introduction: For sponsors planning an Abbreviated New Drug Application (ANDA) or Abbreviated New Drug Submission (ANDS), one of the first
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Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs
CDMO Technology Transfer Peptide Technology Transfer: A Sponsor’s Step-by-Step Guide to Moving Programs Between CDMOs By Anusha Sinha • July
Endosomal Escape in Peptide Oligonucleotide Conjugates (POC) Therapeutics: Mechanisms, Challenges, and Engineering Solutions
Introduction Endosomal Escape in Peptide Oligonucleotide Conjugates (POC) Therapeutics refers to the physical translocation of synthetic nucleic acid-peptide chimeras from
Rubber and Elastomer Leachables: Why Container Closure Elastomers Are Your Highest Extractables and Leachables Risk
Introduction Container closure elastomers are considered one of the most significant sources of extractables and leachables in pharmaceutical packaging. Their
Data Integrity and 21 CFR Part 11 in a GMP Extractables and Leachables Lab
Introduction: GMP Data Integrity for Extractables and Leachables Testing has become one of the most important compliance requirements in pharmaceutical
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