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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Peptide-Related Impurities and Degradation: ICH Q3A/Q3B Considerations Unique to Peptide APIs
Introduction Synthetic peptide active pharmaceutical ingredients (APIs) present unique regulatory and analytical challenges because conventional International Council for Harmonisation (ICH)
Nitrosamine Testing for Antibiotics and Beta-Lactam APIs: Structural Risks and Analytical Approach
Introduction Nitrosamine Testing for Antibiotics and Beta-Lactam APIs is a specialized analytical mandate focused on the detection, identification, and quantification
Poly(lactic-co-glycolic acid) Characterization and Testing Services: Particle Size, Encapsulation Efficiency, and Release Profiling
Introduction Poly(lactic-co-glycolic acid) characterization provides the essential analytical data required to control degradation rates, optimize drug entrapment, and ensure batch-to-batch
What Is the Role of the CTD Format in Generic ANDA and ANDS?
Introduction: The CTD Format for Generic ANDA and ANDS Submissions plays a fundamental role in the successful approval of generic
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Canadian vs. US Peptide CDMOs: Which Is Right for Your Program?
Peptide CDMO Selection Canadian vs. US Peptide CDMOs: Which Is Right for Your Program? By Anusha Sinha • July 22,
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Peptide CDMO vs. CMO: Which Does Your Program Actually Need?
Peptide Manufacturing Strategy Peptide CDMO vs. CMO: Which Does Your Program Actually Need? By Anusha Sinha • July 22, 2026
Peptide CDMO vs. CMO: Which Does Your Program Actually Need? Read More »