IDT Biologika to provide live virus filling and finishing services to BARDA
The award comes from the Biomedical Advanced Research and Development Authority (BARDA) and includes an initial commitment of $100,000, subject to task orders for a maximum amount of $50m.
Per the contract, IDT Biologika will provide services to support cGMP and non-GMP filling and finishing of a variety of medical countermeasure products, which the organization uses for stockpiling and response through several different initiatives.
Read: BARDA talks medical countermeasure manufacturing
According to IDT, the company will support live virus/vectored vaccine fill finish and potentially for small molecule injectables, large molecule sterile injectables, monoclonal antibodies, and other development-stage and FDA-approved medical countermeasures.
As a second part of the contract, IDT will also provide rapid response readiness for medical countermeasures within an accelerated time frame.
Jose Ochoa, Chief Business Officer at IDT Biologika told us the company doesn’t have any plans currently to increase capacity.
“We can meet the expected contract requirements with existing capacity using a combination of resources,” he said, referencing the company’s facility in Germany and the US.
What facilities will be used, one or both, will depend on the government's need in terms of volume and speed, Ochoa explained.
US-based contract manufacturing
IDT recently celebrated its first year of operations in the United States, after opening its doors last September in Rockville, Maryland.
As Outsourcing-Pharma.com previously reported, the site’s production infrastructure has been upgraded for clinical Phase I and Phase II vaccine and viral vector projects.
A new packaging line lets us boost our efficiency with shorter downtimes due to batch and format changes & additional software capabilities pic.twitter.com/59jbf1KIyc
— IDT Biologika (@idtbiologika) October 24, 2016
The company has also added several new capabilities during the past year and is in the process of an expansion that will introduce quality upgrades.