Advances in Continuous Manufacturing of Drug Product, Commercial Spray Drying & HPAPIs/SDD at Hovione

Applying extensive knowledge, data, and a Development by Design (DbD) approach has enabled Hovione to accelerate spray drying development; reducing cost and time to get challenging drugs to patients in need.

Spray drying is a continuous process that involves flash drying under mild conditions (often below 50ºC for less than one minute) of the drug substance/polymer mixture. It also allows for careful control of particle properties (particle size, bulk density, degree of crystallinity, etc.), provides for numerous formulation options and is readily available at all scales. In addition, it is particularly suitable for thermally sensitive materials. Spray drying is becoming the most used technology to manufacture amorphous solid dispersions (ASDs).

The application of sophisticated drug discovery methods has led to much better, but also more complex, chemical entities that suffer from poor water solubility/bioavailability. In fact, 40% of drugs currently on the market and 90% of candidates in the pipeline fall into this category. These complex small-molecule drug substances require enabling drug delivery technologies to achieve the desired level of efficacy.

Hovione New Jersey site more than doubles its capacity to manufacture drug substance. The expansion will add an additional 30,600 ft² (2,843 m²) to the existing 24,000ft² (2,211m²) facility. It will introduce new drug substance capacity, a new spray dryer able to handle potent compounds and analytical chemistry labs.

The site will be unique in offering at a single location: drug substance, spray drying, hot melt extrusion, and drug product manufacturing services using innovative continuous manufacturing technology.

Hovione’s focus on learning the underlying principles of spray drying processes resulted in the generation of large quantities of data that now reside in our extensive database. By combining our modeling capabilities with this extensive prior knowledge, it is now possible for Hovione to closely correlate laboratory conditions to those that will be attained at commercial scale. This Hovione approach is referred to as Development by Design (DbD). It is a systematic methodology that involves the use of predictive tools, scale-independent correlations and prior knowledge. It enables Hovione to achieve a great balance between costs and risks, and to reduce the experimental burden of multiple scale-up stages by focusing the resources where and when they are really needed.