Introduction: Extractables and leachables in dexamethasone injectables represent one of the most critical — yet often underestimated — challenges in […]
Extractables and Leachables in Dexamethasone Injectables Read More »
Introduction: Bioanalytical method development for mRNA therapeutics is fundamentally different from conventional drug modalities — and getting it wrong at
Introduction: GMP manufacturing of peptide-oligonucleotide conjugates sits at the intersection of two highly complex chemistries — and getting it right
GMP Manufacturing of Peptide-Oligonucleotide Conjugates: What to Expect from a CRO Read More »
Introduction: When you decide to outsource peptide characterization, the quality of your results depends less on which CRO you choose
Introduction: PLA stereochemistry — specifically the ratio and arrangement of L- and D-lactic acid units — determines crystallinity, degradation rate,
PLA Stereochemistry: PLLA vs PDLA vs PDLLA and Their Impact on Drug Delivery Performance Read More »
The modern pharmaceutical landscape is experiencing a significant transformation, moving beyond traditional low-molecular-weight compounds toward larger and more structurally sophisticated
Procurement Strategies for PLGA, PLA, PCL, and IND-Enabling Studies Supply Sourcing biodegradable polymers for IND-enabling studies requires the selection of
PLGA, PLA, and PCL for IND-Enabling Studies: What to Source and When Read More »
Introduction A formal nitrosamine risk assessment should begin during the preclinical stage of development, specifically during candidate selection and the
When Should You Start Nitrosamine Risk Assessment in Your Drug Development Program? Read More »
Introduction Developing reliable bioanalytical assays for emerging therapeutic modalities requires navigating an increasingly complex biophysical environment. When establishing analytical strategies
Introduction: Pharmacopoeial methods for nitrosamine testing were not purpose-built for the sensitivity levels modern regulators now demand. When the nitrosamine
