Vetter gets green light for new manufacturing plant
manufacturing license for its new facility which will expand its
services by adding vial filling for lyophilised (freeze-dried)
products to its portfolio, in addition to dual-chamber syringes and
cartridges filling.
The company's new biopharmaceutical production plant located at its Ravensburg Vetter South (RVS) site, represents a further step in its development as a leader in the manufacturing of lyophilised drugs.
The license comes after a planning and construction period of three years and an investment of €100m.
With this new expansion, Vetter can now fill active substances for its customers in all the common administration forms including single- and dual-chamber syringes, cartridges and vials.
"The market of injectables is a future growing market, especially many biotech products are in the pipeline of our clients in the next coming years," Dr Juergen Koch, Vetter's managing director told Outsourcing-Pharma.com.
"Vetter has built this facility as a reaction of market and client requests."
Indeed, the increasing influx of biopharmaceuticals, especially sterile injectables, has created many opportunities for specialised manufacturing technologies that are usually not available with pharmaceutical and biopharmaceutical companies.
Lyophilisation, in particular, is a process that is in growing demand in the biopharmaceuticals segment, as it requires a high degree of automation, and contract manufacturing organisations (CMOs) are focusing on tapping this large demand for such specialised niche technologies.
CMOs like Vetter, who have spotted the opportunity in the market, have been building state-of-the-art facilities that rival those of pharmaceutical companies and are constantly upgrading them to enable novel manufacturing processes.
The company said that it can now supports dosage form studies in vials in early phases of product development, as well as the production of material for clinical studies.
One of the main highlights of the plant is that it has nearly the highest possible degrees of automation within aseptic filling, even in details such as automated doors entering cleanrooms, the firm said.
In addition, Vetter now offers more manufacturing and back-up capacity for its patented system - Vetter Lyo-Ject - an innovative dual-chamber technology for liquid/liquid or lyophilised/liquid products.
"With this Vetter supports growing requests from the market to present sensitive products which need to be lyophilised in a user-friendly application system," said Dr Koch.
Dr Koch also said that the facility has at present two production lines and both are running, supported by approximately 200 staff.
In addition, the new production lines are flexible, making it possible to quickly change systems and formats.
"Additional lines can be built-up during running production."
