Oncotec on a growth trend
The cornerstone of success
Since Oncotec got the general Manufacturing Authorization according to Section 13 of the German Medicines Act (AMG) for the manufacturing of sterile, liquid and solid dosage forms, we have been producing sterile injection solutions in vials or ready-to-fill syringes at the Dessau-site. The medicinal products are produced according to the latest international guidelines, whose strict compliance is verified through annual inspections by the State Administration Authorities of Saxony-Anhalt.
As a contract manufacturer, Oncotec has no own authorizations for medicinal products. However, during the long years of active production, we have developed considerable knowledge concerning the filling of liquid cytostatics into injection vials and ready-to-fill syringes. Meanwhile, this extensive know-how of Oncotec has been used both by national and international customers. At the beginning, Oncotec manufactured for small and large pharmaceutical companies in Germany, France, Austria, Greece, Belgium, Denmark and Switzerland.
With a view to the growing market and the increasing demand, Oncotec already decided in 2005 to expand its production capacities for injection vials significantly. With a total investment expenditure of EUR 12.5 million for 2005/2006, which also contained subsidies granted by the State of Saxony-Anhalt, the production area of 1,000 m² (Oct-2005) could be more than doubled to 2,200 m² (Jan-2007). Along with state-of-the-art equipment and safety technology, also 24 new jobs were created by the production expansion. Hence, the Oncotec-team increased to 68 employees. In 2007, Oncotec could incorporate three trainees and has been making an important contribution in supporting young people in the region since then.
Due to the considerable investments into new systems and new employees during the first 10 years, Oncotec could lay the cornerstone for the success of the subsequent years and could continue to produce highly effective medicinal products according to current national and international quality criteria and safety-standards and, therefore, to ensure the site of Rodleben/Tornau as a location for pharmaceutical manufacturing.
On the way to success - Reconstruction and expansion
To cover the demand especially for the world-wide market, the „old“ Lines 1 (vials) and 2 (syringes), which were 10 years old by then, were extended by further modern filling lines in the isolator.
The south-wing of Building 311 was extended by an additional vial-filling line (Line 3) of Company Fa. Groninger.
After the successful launch of Line 3, we started to fill our first originator preparation in 2007. Afterwards, the product portfolio has been rapidly developed. Slight technical modifications, e.g. in the isolator in 2009, made it possible to manufacture product batches for the global market, such as for the USA. This is also reflected, among other things, by the increasing number of inspections by foreign authorities since 2012.
The constantly increasing demand for MTX-syringes led to the planning and realisation of a high-performance filling line (Line 4) in co-operation with Company Fa. Bosch. From 2011 onwards, this line has superseded successfully the syringe-production on Line 2. At the same time, our first inspection by foreign authorities was performed by the south Korean authorities. In 2014, the US-FDA approved the MTX-syringe production. From then onwards, we have also expanded the product range on this line.
In 2016, nearly 24 million syringes were manufactured. This clearly reflects the significance of this line and of our main product MTX. It is only consequent in this regard to remove the visual inspection of the syringes for the extension of the value-added chain back again into the own company. To make this further expansion possible, the purchasing of Buildings 310 was an essential precondition. The south-wing was created after the gutting of the building.
630 m² of hygiene-area for the fully-automatic visual inspection of syringes, half-automatic visual inspection of vials and the manual visual inspection were created in 2016. Additionally, areas were created for incoming goods of 210 m² and for outgoing goods of 140 m² as well as changing facilities for ladies and gents on the first floor (total area of 150 m²). On the second floor, 53 new office workplaces were provided for the growing number of staff.
Outlook
Design the future successfully
After the first 20 years of the company-history of Oncotec, which have been marked by growth, we can look in the future with confidence and excitement: With the implementation of the visual inspection of MTX-syringes, we will continue this success-story. The manual, half-automatic and fully-automatic visual inspection of our vial-products and syringe-products will be brought together in our future visual-inspection competence-center.
With a large investment for Line 5 in Building 310, we have taken the right step for the future production of innovative and high-profile cytostatics like ADC-products.
Through the usage of the modern robot-technology of Line 5, we can keep up with the demands of science and technology on the highest level. From 2018 onwards, we will offer ultra-pure media from our own manufacturing and we will develop our know-how and our competences in this field.
The expansion of Freeze-Drier 4 by one compact filling line will enable us to realise ADC-products on a small scale as well as further challenging development-projects.
We will enlarge laboratory-capacities to further satisfy the demands of product-development and routine. Along with the adjustment of technological possibilities, we will especially invest into the education and training of our employees to make them able to act in a motivated, competent and/or careful way as an executive and according to the necessary GMP-awareness.
We will promote the implemented optimisations of different processes to use the available capacities in an efficient and effective way. We want to continue using synergies within the co-operation network and at the site.
By doing so, we can react promptly to the rapidly changing markets and adapt production to the high demands of our customers to its optimum extent. In the long term, we want to respond to the market with even more flexibility by means of a wide customer portfolio.
By extension of our service-range, we will also extend our value-added chain and, by doing so, we will ensure the growth of Oncotec. With a zest for action, we are looking forward to the challenges of the next years.
Dr. Grit Rothe, Gerald Scheer
Commitment to quality