AMRI has announced its Burlington, Massachusetts aseptic facility will produce Docetaxel Injection (non-alcohol formula) as part of a parenteral drug development and manufacture deal with Eagle Pharmaceuticals.
The drug is the first to be approved from the facility, and according to AMRI CEO William Marth its commercial scale manufacture comes following successful development and validation at the site.
“The Docetaxel non-alcohol drug product attributes, as well as the manufacturing process itself, are considered to be both unique and challenging with the process containing several critical process control parameters,” he said in a statement.
Docetaxel Injection is the first alcohol-free formulation approved in the US for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle licensed the product from Teikoku Pharma in October last year.
Manufacture of Docetaxel forms part of a larger agreement which will see AMRI develop and initially provide cGMP manufacturing and analytical support for the registration of several other new product candidates in Eagle’s sterile injectable pipeline.
“This agreement will allow Eagle to expand our portfolio of injectable therapies in a focused and efficient manner by coupling our internal expertise in clinical, regulatory and commercial execution with AMRI's unique depth of experience with aseptic formulation development, working with complex Active Pharmaceutical Ingredients (API) and handling highly-specialized manufacturing requirements,” said Eagle’s CEO Scott Tarriff.
“We expect to more efficiently scale our development infrastructure and speed our market entry with new products, ultimately building long term value for customers and shareholders alike.”
Burlington site
The approval is positive news for the Burlington site which has had a checkered regulatory history.
AMRI bought the facility in 2010 when it acquired Hyaluron for $27m.
Just weeks completing the deal AMRI received an FDA Warning Letter citing a number of cGMP violations at the site.
A close-out letter was issued in November 2013, and since then the firm has boasted of huge demand for aseptic fill/finish services from the site.
AMRI and Icagen
In other news for the CDMO, AMRI will offer its pharma clients access to ion channel and transporter technology through a collaboration inked with Icagen.
Icagen's portfolio of assay tools and technologies include a collection of ion channel cell lines and proprietary XRpro X-ray fluorescence technology, which will be integrated within AMRI’s drug discovery solutions business.
Rory Curtis, Site Head of AMRI Buffalo, said access to unique cell lines and emerging technologies would complement the firm’s current offerings, adding: “Icagen's expertise in ion channel drug development and their comprehensive portfolio of assay tools will be beneficial to AMRI's drug discovery efforts.”