What Documents and Specifications to Provide When Outsourcing Peptide Characterization to a CRO
Introduction: When you decide to outsource peptide characterization, the quality of your results depends less on which CRO you choose […]
PLA Stereochemistry: PLLA vs PDLA vs PDLLA and Their Impact on Drug Delivery Performance
Introduction: PLA stereochemistry — specifically the ratio and arrangement of L- and D-lactic acid units — determines crystallinity, degradation rate,
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What Makes a Peptide Drug Different from a Small Molecule? Analytical and Regulatory Implications
The modern pharmaceutical landscape is experiencing a significant transformation, moving beyond traditional low-molecular-weight compounds toward larger and more structurally sophisticated
PLGA, PLA, and PCL for IND-Enabling Studies: What to Source and When
Procurement Strategies for PLGA, PLA, PCL, and IND-Enabling Studies Supply Sourcing biodegradable polymers for IND-enabling studies requires the selection of
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When Should You Start Nitrosamine Risk Assessment in Your Drug Development Program?
Introduction A formal nitrosamine risk assessment should begin during the preclinical stage of development, specifically during candidate selection and the
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Bioanalytical Method Development and Validation for mRNA Therapeutics and LNP Drug Products
Introduction Developing reliable bioanalytical assays for emerging therapeutic modalities requires navigating an increasingly complex biophysical environment. When establishing analytical strategies
Can Existing Pharmacopoeial Methods Be Used for Nitrosamine Testing? Gaps and Limitations
Introduction: Pharmacopoeial methods for nitrosamine testing were not purpose-built for the sensitivity levels modern regulators now demand. When the nitrosamine
Case Study: Identification of Unexpected Sulfur-Containing Leachables in a Biologic Container System
Introduction The structural integrity and long-term stability of biopharmaceutical drug products depend heavily on the chemical inertness of their primary
Drug–Polymer Interaction in Biosimilar Depot Formulations: LC-MS Insights
Introduction Long-acting injectable (LAI) depot formulations based on biodegradable poly(lactide-co-glycolide) (PLGA) polymers represent one of the most effective technologies for
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Common Failures in Dexamethasone Injectable Development
Introduction to Dexamethasone Development Challenges The development of sterile and stable dexamethasone injectable formulations demands careful management of numerous physical,
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