Novo Nordisk unveils plans for $100m API plant
pharmafile | March 17, 2014 | News story | Manufacturing and Production |Â Â API, FDA, Novo Nordisk, Taylor, copenhagenÂ
Novo Nordisk says it will invest around $100m in a new pilot facility to make the active pharmaceutical ingredients (APIs) for its pipeline of diabetes drug candidates.
The 2,700 sq. m. purification facility – based at the Danish drugmaker’s main Bagsvaerd site that lies around 10 kilometres northwest of Copenhagen – is scheduled to be operational by the end of 2016 and will eventually employ around 35 staff.
The pilot facility will be used to produce candidates in the company’s early-stage diabetes pipeline, which includes long-acting basal insulin analogue NN1436 as well as a series of long-acting orally-active GLP-1 analogues (NN9926, NN9927 and NN9928) and oral insulins NN1953, NN1954 and NN1956).
The project initially involves establishment of a pilot plant with one purification line, but Novo Nordisk indicated that the capacity of the facility could be doubled if required.
The company has been bolstering its chemistry, manufacturing and control (CMC) supply division, which develops and produces all peptide and protein formulations in the company’s pipeline, as it brings this pipeline through development.
One of the key functions of the unit is to develop preliminary and final manufacturing methods and formulations for new APIs.
Jesper Bøving, senior vice president, CMC supply, said the firm plans to add around 100 staff to its current headcount of 1,200 in the division over the course of this year to help accelerate the development of these early-stage assets.
Novo Nordisk needs its pipeline to deliver the goods after a serious setback last year when two new insulin products – Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart) – were delayed in the US for up to two years by an FDA request for more information. Tresiba was cleared in Europe in 2012.
At the time the company said the hold-up related to a requirement for new clinical data on the products, as well as problems at an aseptic filling facility at Bagsvaerd that were revealed during a US Food and Drug Administration (FDA) inspection.
Similar manufacturing issues were cited when the FDA also decided to delay approval of Novo Nordisk’s catridecacog, a recombinant Factor XIII treatment for haemophilia.
Phil Taylor
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