Aspetic spray drying installation

By Doug Hecker

The aseptic spray drying installation acquired by Hovione is the only one known to us that has successfully passed a FDA PAI (Pre-Approval Inspection).

“The challenges our customers face are opportunities for Hovione.”
-Doug Hecker

What types of dryers are used in the development and manufacture of pharmaceutical products?

DH. In the pharma industry, focusing on active pharmaceutical ingredients (APIs), drug products (DPs) and intermediate drug products (IDPs), the drying of oral drugs typically involves fluid-bed dryers, tray dryers, spray dryers, tumble dryers and filter dryers. With respect to parenteral drug products, lyophilization is the mainstay for drying. However, it should be noted that APIs used for parenterals can be isolated by any of the aforementioned techniques provided that the drug product formulation can be sterilized (i.e. via sterile filtration, heat or gamma irradiation). If the formulation cannot be sterilized, then the API must be made sterile during manufacture and packaged aseptically.

One item that should be noted when comparing drying processes at API manufacturers to those at drug product manufacturers, is that it is commonplace for API manufacturers to handle and recover/recycle tremendous volumes of (flammable) organic solvents during isolation and drying. It is very rare to find a drug product manufacturer accustomed to handling (flammable) organic solvents at any significant level.

What are the benefits of aseptic spray drying over other types of drying?

DH. At a high level, the key advantages to aseptic spray drying are: throughput (i.e. cost reduction) and the ability to co-process API with stabilizers, solubility enhancers, etc. Additionally, it allows one to define, improve and/or manipulate physical characteristics of the resulting powder.

When looking at the other types of drying technologies that aseptic spray drying directly competes with, the one that stands out is lyophilization. Unfortunately, an apples to apples direct comparison of the two technologies is difficult, due to the enabling nature of spray drying. However, on a relatively simplistic basis, and what is of concern to customers, is that if a problem arises during aseptic spray drying, we can stop the process, isolate/fix the problem and restart, thus, saving at least a portion of the batch. If a similar problem occurs during lyophilization, the entire batch is most likely compromised and lost.

In October last year, Hovione acquired an aseptic spray-drying production line, vial filling and back up utilities from Acusphere. Why did the company choose to make this acquisition?

DH. The aseptic spray drying installation acquired by Hovione is the only one known to us that has successfully passed a FDA PAI (Pre-Approval Inspection).
 
During the past six years, we have seen growth in our spray-drying business for both non-potent and potent compounds and formulations, the emergence of the solid dispersions market and the great work that other companies have been doing on utilizing aseptic spray drying in vaccines to eliminate the cold supply chain and thus actually delivering therapeutic doses of vaccines to third world countries. Based on all of these factors, when the opportunity to acquire this technology and additional operational capabilities became available, it was a natural fit and in alignment with our strategic growth plan.

How does the addition of this new equipment allow Hovione to solve current and future challenges?

DH. The challenges our customers face are opportunities for Hovione. A considerable fraction of the new chemical entities (NCEs) being developed have limitations in terms of solubility and bioavailability. Moreover, the percentage of NCEs with bioavailability limitations has increased over the past five years and this trend is expected to continue in the future.

With these issues and the experience we have in solving these problems using conventional spray drying for non-sterile compounds, the obvious next step was to raise the bar and solve these problems for APIs, NCEs, IDPs and DPs that needed to be manufactured aseptically. Additionally, as this is an emerging technology, utilization of Hovione’s aseptic spray drying technology does offer our customers the opportunity to develop intellectual property around their products.

Biography

Doug Hecker is currently working as the Global Business Director for Particle Design at Hovione. He has more than two decades of experience in GMP manufacturing for APIs, novel excipients and sterile drug products. Hecker had a primary role in establishing Hovione’s contract GMP spray drying business.