AqVida reflects on landmark year of 2016
Press Release | AqVida GmbH
JANUARY 12, 2017
Hamburg, Germany: – AqVida is reflecting on a year that has proved a pivotal milestone for the innovative German oncology generics specialist in its march towards greater strategic integration between product and process.
The year 2016 featured several important highpoints for AqVida, including a prestigious award, attendance at several key events, the opening of new hi-tech manufacturing facilities, all culminating in a key product launch in December.
Robotic aseptic production
A key date was October 21, when AqVida Managing Director and founder, Wolfgang Heinze, presided over the formal inauguration of the new ‘zero loss’ production plant at Dassow, which represents a step change for the European pharmaceutical industry by incorporating robotic technologies and flexible lean production concepts.
The AqVida-Team escorted political and business leaders through the plant, to show the highly advanced sterile technical areas, laboratories, and clean room including a glimpse of the new robotic filling line in action.
The innovative aseptic vial filling line using Isolator technology will set new industry standards in safety, efficiency and flexibility with no need for lengthy resets or reformats of the production line. The filling line was co-developed by AqVida to anticipate emerging client needs for ever-greater levels of cost effectiveness, regulatory compliance and elimination of waste.
Zero loss concept
Fully robotic vial handling and filling of vials directly on a weighing cell allows high flexibility with accurate 100% weight control. The ‘zero loss’ process design philosophy emphasizes elimination of any spillage and near total recovery and re-use of all physical components, such as stoppers and caps.
The zero loss filling process and small batch sizes makes the AqVida filling line ideal for production of highly targeted oncology medicines as well as for development projects and clinical trials. The facility is also suitable for filling cytostatics and antibody drug conjugates (ADCs).
A series of regulatory milestones passed during year enabled AqVida to launch Imatinib as a generic version of Gleevec® to the European market on December 23, following September’s submission of Sunitinib generics application for European approval, while pushing ahead to market launch in territories that are patent-free.
AqVida generated particular interest in out-licensing opportunities for Sunitinib, a generic version of Sutent®, during its highly successful showing at CPhI Worldwide 2016 Show in Barcelona, a further highlight of the year.
During the year, AqVida also attended the Euro PLX conference and presented its new filling line to the 2016 Pharma-Kongress in Dusseldorf.
Best oncology provider
In November, Global Health & Pharma Magazine named AqVida as “Best Oncology Product Provider, Europe” in its annual awards.
Summing up the year, Wolfgang Heinze said:
“For years AqVida has specialized in development, manufacturing and distribution of generic pharmaceutical products, especially in the field of cancer therapy. The current backward integration using our own production facility represents an important step in our goal to set new standards in oncology production.”
“The combinations of innovative products and processes that we have achieved during 2016 have taken AqVida to a new and higher level,” Mr. Heinze concluded.
AqVida is a German oncology FDF manufacturer that is fully dedicated and specialized in the development, registration, manufacturing and distribution of finished dosage forms mainly for the oncology sector. It has developed a portfolio of medicines for treating the most common types of cancer.
AqVida’s expertise in generic oncology products has made the company a leading partner in the pharmaceutical industry.
AqVida works alongside some of the leading names in the oncology sector. In co-operation with its partners, AqVida has achieved substantial development and growth with its oncology portfolio.
AqVida is a pharmaceutical company with an impressive track record in fulfilling all client requirements from API sourcing through to EU market release for finished products. Teams of experts in development, regulatory affairs, patent issues and laboratory work bring skills and knowledge together to achieve optimum results for customers.
AqVida complies with all German and EU legal requirements for the pharmaceutical industry and is GMP certified by the German Health Authorities. As a European organization, AqVida has the knowledge and resources to provide regulatory support to meet the requirements of the complex and highly regulated EU market.
Jürgen Lehmberg, Commercial Director, AqVida GmbH
Wolfgang Heinze, CEO, AqVida GmbH
Tel: +49 40 380 37190