In 2018, we saw a record-setting year for new-molecular entity (NME) approvals (59) at the FDA1 versus 46 in 2017. 58% were for orphan drugs (patient population less than 200,000 in the US) with 17 biologic-based NME’s. Biosimilars are gaining traction in Europe, in particular. Major factors that are driving the market growth are next-generation business, high growth in chronic diseases, less expensive biosimilar drugs and favorable government regulations.

Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.

The properties of the particles that make up a pharmaceutical powder directly affect its behavior, a classic example being that finer particles are usually associated with poor flowability. However, so too do other ‘system’ variables, such as the degree of aeration or consolidation. The analytical toolkit required for the knowledge-led control of formulation properties therefore necessarily extends from particle characterization through to bulk powder testing techniques. Particle characteristics are the levers manipulated to meet performance targets, but bulk powder properties often define some of these targets. Marrying the results from both types of analysis is often the key to efficient progress.

The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.