Foreign Particle Analysis: Identifying the Unexpected
An unexpected particle found in a pharmaceutical product can [...]
Analytical Method Development: An AQbD Approach
An analytical method needs to provide reliable results for its [...]
Antibody-Drug Conjugates: The “Trojan Horses” Transforming Oncology
Antibody-Drug Conjugates (ADC) have rapidly emerged as one of the [...]
Microbiological Control of Biologics: Testing Strategies
Microbiological safety of biologic products is a critical step throughout [...]
Nucleic Acids Bioanalysis: Expanding analytical capabilities with LC-MS/MS
Nucleic acid-based therapeutics have emerged as one of the [...]
OINDP Testing: Meeting the Latest EMA Expectations
Orally Inhaled and Nasal Drug Products (OINDPs) are one [...]
Bispecific Antibodies: Challenges in Pharmacokinetic and Immunogenicity Studies
What is a Bispecific Antibody? Bispecific antibodies (BsAbs) are engineered [...]
Particle Characterization Method Transfer: Mastersizer 2000 to 3000 & Zetasizer Nano to Ultra
The discontinuation of the Mastersizer 2000 and the gradual [...]
Biodistribution and Shedding Studies for ATMPs and Gene Therapies: A Practical FAQ
Advanced Therapy Medicinal Products (ATMPs), viral vectors, and other emerging [...]
ICH Q1: A Consolidated Framework for Stability Testing of Biologics
Last year, a long-anticipated change finally happened for stability [...]
