Author Archives: Alejandro Becerra-Arteaga

Viral Clearance in a Downstream AAV Process: Case Study Using a Model Virus Panel and a Noninfectious Surrogate

Over the past decade, adenoassociated virus (AAV) vectors have become established as leading gene-delivery vehicles. In 2017, the pipeline for gene therapies included 351 drugs in clinical trials and 316 in preclinical development (1–4). As those candidates advance, significant efforts are being made in process development and manufacturing for viral vectors, with the overall goal of reducing process impurities while maintaining the highest possible process yield. To address that goal, industry suppliers have developed innovative AAV-specific separation technologies. Thermo Fisher…

Performance of a Salt-Tolerant Membrane Adsorber in Flow-Through Mode

Monoclonal antibodies (MAbs) have become the most prevalent therapeutics in the biopharmaceutical industry. Their downstream purification typically involves protein A chromatography as a capture step followed by one or two additional chromatographic polishing steps. Additional unit operations dedicated specifically for viral clearance (e.g., viral inactivation and filtration) are added to ensure product safety. According to a survey of Amgen processes, after processing through a protein A column, only trace amounts of impurities such as Chinese hamster ovary cell protein (CHOP)…