Athenex is moving forward with the construction of a new 320,000-square-foot pharmaceutical manufacturing facility in Dunkirk, NY, and has hired the German engineering firm, M+W, to design and construct the facility.
On Dec. 29, 2017, Athenex, a biopharmaceutical company, entered into an agreement with M+W, a German design, engineering, and construction company, for the design and construction of a new pharmaceutical manufacturing facility in Dunkirk, NY. The cost of the 320,000-ft2 facility is estimated between $205 million and $210 million.
According to a company filing with the US Securities and Exchange Commission (SEC), the cost of the facility will be paid in part by the State of New York. This follows a previously disclosed grant of up to $200 million that the state awarded to Athenex. The remaining amount will be paid by the company. The payments will be made over time, dependent on completion of certain milestones under the agreement. The New York State Empire State Development Corporation must approve any payment from the grant funds.
The construction of the manufacturing facility is part of a $1.62-billion investment that Athenex is making over 10 years to expand its Dunkirk site and its North American headquarters in Buffalo, NY, according to an announcement by Governor Andrew Cuomo in February 2016. In July 2017, Athenex obtained New York State and local tax incentives related to the new Dunkirk facility.
Source: Athenex company filing with Securities and Exchange Commission
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.