07.09.25 -- Involve CMC And Formulations Experts Early In Process Development

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the monoclonal antibody (mAb) impacts the behavior of the drug product.

See how aseptic, sterile micro-connectors provide a simple, efficient method of connecting tubing for small format assemblies to help improve efficiencies, reduce time and total cost, and mitigate risk.

Small-scale downstream studies play a critical role in enabling efficient, low-risk tech transfer for biologics development.

Breakthrough therapies are challenged by complex, batch-based manufacturing. A novel, integrated system enables continuous processing, improving consistency and reducing manual handling for advanced modalities.

We review a single-use TFF device that increases operator safety, and also saves time for improved batch turnaround and flexibility in the ADC manufacturing plant.

In this application note we review if a shorter residence time could be used for more rapid cycling without impacting elution width, yield, Protein A leaching, or HCP removal.