Since acquiring the facility in 2015, IDT Biologika has upgraded the site’s production infrastructure for clinical Phase I and Phase II vaccine and viral vector projects.
The company has also added several new capabilities and is in the process of an expansion that will introduce quality upgrades. The construction project also increases IDT’s capacity and introduces new production technologies at the site.
According to the company, these upgrades are designed to facilitate smooth project transfer between its Rockville and Dessau sites.
To learn more about the company’s first year of operation North America, Outsourcing-Pharma.com talked with Michael Jenkins, Site Director for IDT’s Rockville viral vaccine manufacturing facility.
Outsourcing-Pharma.com: What have been the greatest challenges over the past year?
Michael Jenkins: We are executing a facility expansion in Rockville, which is designed to harmonize our manufacturing quality with IDT in Dessau (Germany) and bring in a manufacturing process developed by IDT in Dessau.
We have had to quickly build relationships with our German colleagues and develop into a high performing team to make sure the expansion project is successful. We have introduced best practices from IDT in Dessau to IDT in Rockville, and some of Rockville’s best practices have been incorporated by IDT in Dessau.
Executing a construction project while keeping production active is also extremely challenging. Our manufacturing stretches over three separate floors and we are working through one floor at a time to minimize project disruptions and balance completing client projects with executing the construction work.
We changed our operating focus to one of a “facility mindset” and our perspective from a non-profit organization (having purchased the facility from Aeras) to a for-profit CMO.
Many of our production areas are much busier than they were in the past.
Outsourcing-Pharma.com: What trends have you seen evolve in this time?
Jenkins: We are seeing many novel vaccine manufacturing opportunities that don’t fit into conventional facilities (i.e., facilities designed to produce monoclonal antibodies). These projects require unique know-how in both manufacturing and assay development. Fortunately, we are equipped to address these trends in our facilities.
Outsourcing-Pharma.com: How has client demand changed?
Jenkins: We are clearly seeing a general increase in request for proposals and busier production suites, partially due to market conditions and partially due to being able to offer fully integrated services from development all the way to large-scale commercial production in conjunction with IDT’s facilities in Dessau.
Outsourcing-Pharma.com: Based on the current state of the industry what do you expect from the next five years?
Jenkins: We expect to continue rapid growth, and to introduce additional technologies, especially for the production of viral-based vaccines. As new diseases such as Zika appear on the horizon, we expect to be more and more involved in helping advance vaccine candidates from research to development and on to large-scale commercial production.