In January of 2009, Isogen began using its advanced sterile processing technology to help fill a gap in the injectable manufacturing market. They opened a small scale sterile filling service plant in Delaware to fulfill the needs of the pharmaceutical industry. It now provides Good Manufacturing Processes (GMP) for vial and syringe filling. The primary purpose of this new business venture is to meet specific customer requirements in contract manufacturing.
This phase 1 facility addresses process and capacity problems normally encountered in low-volume clinical and early stage commercial sterile filling applications. This market segment is estimated to be worth about 2 billion dollar a year. Often, the small manufacturers lack the breadth of expertise to accommodate the complicated needs of this biopharmaceutical market. Since this relatively small niche in the overall market is less profitable than large scale commercial filling, the big players tend to stay away.
100 million dollars and 4 years of development are usually required to develop the necessary sterile capacity for a given product. This is a huge risk and investment considering that regulatory approval of the candidate drug in question may not ever happen. In other words, the effort could potentially be a huge waste of time and money. The reluctance of companies to expend that kind of capital over an extended period of time is understandable given this level uncertainty over the outcome.
The processes that Isogen has developed create flexibility in their effort to meet the needs of each customer. They are currently incorporating isolator barrier technology into each of the seven manufacturing suites at the plant. This will allow both potent and non-potent compounds to be handled according to the highest standards. This isolator technology has won the endorsements to be used in aseptic manufacturing by both the European Medicines Agency in 2003 and the U.S. Food and Drug Administration in 2004. It is scheduled to go online sometime this year at the Delaware facility.
More About Isogen
Isogen strives “to improve product quality and speed product to market, while enhancing product robustness, scalability, and economics.” They also seek to be “partners of choice for outsourcing of sterile filling” for clinical and early stage commercial manufacturing.
Their advanced isolation and containment technology offers an integrated approach to safely handle most therapeutic compounds including live viruses and cytotoxics. Their multiproduct capability allows the streamlining of the process required for getting injectable medicines to market in a timely manner. The company strives for full transparency during testing and manufacturing operations. They even encourage in person presence by the customer during these activities.
The highest levels of containment and contamination control are maintained because of the fully segregated filling suites at the facility. The design promotes safety for both operators and products. The modular cleanroom design was integrated into the building shell itself. This smart move saved 8 weeks and 10 of thousands of dollars in construction costs. The modular approach also made the rooms an effective barrier while allowing them to be demonstrably more cleanable than otherwise.
Speaking of third party sterile processes, there are still many facilities that routinely send instruments and other materials out for sterilization. However, the cost of purchasing an autoclave for on-site use is much less expensive than the price tag for a full manufacturing operation like the one mentioned above. Now may be the time to invest in a steam sterilizer to handle day-to-day functions in house. Check out our free report to find out which cost effective solution is right for you.
