For long-term manufacturing success, you need to look beyond the process and account for an amalgamation of many important factors. Your process will go through many different phases, and it needs to be scalable throughout, or you will incur additional challenges and costs.

When life science manufacturers can provide all of the technologies and expertise necessary to manufacture a drug, all scientists need to focus on is discovery.

Find recommendations for immobilization of histidine-tagged molecules (ligands) by capture to an anti-histidine antibody covalently coupled to a sensor chip surface.

Introducing analytical technology into the cell culture process development workflow can greatly speed up the time to results. This platform is an analytical instrument that can easily be implemented in cell line development labs to facilitate rapid determination of product yield.

Chemistry Manufacturing and Controls (CMC) for gene therapies is one of the biggest obstacles when moving towards regulatory approval and presents a significant risk to the success of new gene therapy drug candidates today. Here we review a framework for a QbD assessment for AAV products within the Chemistry Manufacturing and Controls (CMC) documentation.

Local delivery of biotherapeutics to the lung holds great promise for treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge.

Clone selection is a significant upstream bottleneck slowing bench-to-bedside development progress for new mAbbased therapeutics. With mAb-based product development addressing diseases of such massive financial and societal implications, researchers using analytical power tools can reach their goals faster and shorten the bench-to-bedside development path, benefitting both patients and the bottom line.

Cell line development involves multiple processes. Large numbers of clones are screened and selected on the basis of productivity and stability. An established platform for rapid titer of antibody clones can enable quick selection of high-producing clones.

Dr. Gene Lee, Vice President of Technical Development at AltruBio, sat down to discuss getting the developability question right and why it’s important to understand your end game as early as discovery.

Geoff MacKay, president and CEO of AVROBIO, talks with The Business of Biotech podcast about the scale up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.