ARL Bio Pharma provides analytical and microbiological solutions for biologics, supporting quality and compliance across drug product development and commercialization.
ARL Bio Pharma designs tailored analytical strategies to support product quality, process understanding, and compatibility. Using advanced technologies and orthogonal approaches, our laboratory generates high-resolution insights into complex biologics using Liquid Chromatography-Mass Spectrometry (LC-MS)-based methods.
ARL Bio Pharma offers biologic characterization services that evaluate the structure and purity of various therapeutic proteins, including intact monoclonal antibodies (mAbs), bispecific antibodies, antibody-drug conjugates (ADCs), fusion proteins, and other peptides and proteins. These services provide essential data for protein identification, mass confirmation, and structural characterization to support the quality and consistency of drug products.
Process characterization is a critical development phase where manufacturing parameters are systematically evaluated to understand their impact on product quality. ARL Bio Pharma combines risk assessment, experimental design, and advanced analytics to build a robust, controlled process that supports product quality and robustness.
Process qualification verifies that the manufacturing process can consistently deliver a product that meets predefined quality attributes under cGMP conditions. ARL Bio Pharma provides comprehensive analytical support to support effective process validation and regulatory compliance.
ARL Bio Pharma provides comprehensive, cGMP-compliant lot release testing to meet global regulatory requirements for drug substances and drug products. Our laboratory’s integrated approach delivers consistent, high-quality data that meets regulatory expectations across the US, EU, and international markets.
Our laboratory has expertise in a broad range of biologics, ensuring quality results and innovative solutions.
