DESSAU, Germany & ROCKVILLE, Md.--(BUSINESS WIRE)--IDT Biologika, a globally integrated manufacturer of vaccines and biopharmaceuticals, with over 1600 employees worldwide, announces today that the Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant for Preparedness and Response (ASPR) at the United States Department of Health and Human Services (HHS) has awarded the company an Indefinite Quantity, Indefinite Delivery (IDIQ) contract1 to provide live virus filling and finishing services with an initial commitment of US $100,000, subject to task order(s) for a maximum amount of US $50 million. BARDA seeks to establish fill/finish capabilities for use of live-vectored virus products in clinical development through licensure. BARDA has contracted with IDT Biologika to provide services to support cGMP and non-GMP filling and finishing of a variety of medical countermeasure products. The company will initially provide services to 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.
“We are honored to have been selected by BARDA to receive this contract award and are pleased to support the United States’ government efforts to develop vaccine medical countermeasures to address public health threats,” said IDT Biologika Chief Executive Officer Dr. Ralf Pfirmann. “IDT has performed live virus fill finish services for a variety of customers, including governments, for many years. This prime contract with BARDA is noteworthy, however, as it establishes IDT Biologika’s first opportunity to provide services directly to the US government. Our state-of-art manufacturing facilities located in Germany and Rockville are well positioned to serve BARDA’s current and future requirements.”
The BARDA contract may be performed over a five-year period and addresses two types of requirements: the first being fill finish services to support the development of live/vectored virus product candidates and medical countermeasures. The second provides for rapid response readiness for fill finish services for medical countermeasures within an accelerated time frame.
“The BARDA award showcases IDT Biologika’s global capabilities and highlights the benefits of IDT’s recent expansion in the United States and Canada,” said José Ochoa, Chief Business Officer of IDT Biologika Corporation and BARDA’s primary point of contact at the company. “We look forward to continuing to develop a strong relationship with BARDA and other US government agencies.”
About IDT Biologika
IDT Biologika is an innovative, privately-held life science company with more than 95 years’ history and expertise in research, development and manufacturing of biologics for the global protection of human and animal health. Headquartered in Dessau-Rosslau, Germany, the company holds an additional animal health vaccine dedicated R&D and manufacturing location in Greifswald – district Riems. In Denmark, the Netherlands, France, Spain, Poland and Canada, IDT‘s Animal Health Business Unit operates through its own sales companies.
In its US manufacturing facility in Rockville, Maryland, IDT Biologika primarily provides vaccine and biologics development for clinical phase I and II projects and provides early development capabilities for the human biologics and vaccine markets. In Canada, IDT Biologika acquired Gallant Custom Laboratories, based in Cambridge, Ontario. Specializing in manufacturing and supplying of autogenous vaccines, the company now does business as “Gallant Customs Laboratories, an IDT Biologika company.”
In the 2015 financial year, IDT Biologika achieved sales of approximately €195 million with its animal health, vaccines, parenteral biologics and final drug products packaging business segments, an approximately 14 percent increase in business compared to the previous year. IDT Biologika currently has some 1,600 employees.
IDT Biologika is a company of the Klocke Group. The Klocke Group companies specialize in contract manufacturing and packaging of pharmaceuticals, vaccines, and cosmetic products. With more than 2,200 employees and producing at eight locations in Europe and North America, the family-owned Klocke Group offers comprehensive services for production and packaging of pharmaceutical products.
1 Services performed under this IDIQ contract are funded by the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advance Research and Development Authority, under Contract No. HHSO1002016000201.