AqVida at full speed towards new robotics plant
Press Release | AqVida GmbH
MARCH 09, 2016
Hamburg, Germany: – North German Oncology Manufacturer AqVida is on course to top out its advanced new production facility at Dassow that will automate many of its manufacturing capabilities. The new plant is set to change the standards in oncology production.
Less than four months after foundation stone ceremony, the Dassow building is structurally almost complete, with “topping out” ceremony to mark completion of roof now scheduled for March 31.
“The main construction of the building is finished, the project is on time,” declared AqVida’s Technical Director, Joachim Bär.
“The next planned step is the completion of the roof system,” he added.
Zero loss technologies
The plant is on schedule to begin operations at the end of 2016, introducing highly advanced robotic automated isolator-based ‘zero loss’ aseptic filling technologies that represent a breakthrough for the oncology and biotech sectors.
“Mid-March will see work start on building services. Preparations regarding the matter are going ahead at full speed,” said Mr. Bär.
“With process equipment, the main focus has been on detailed design, with interface management a very important factor. The first factory acceptance tests (FATs) will be executed in the first Quarter of 2016,” he explained.
AqVida is using latest techniques for designing equipment and processes to support product and patient safety. These include coordinated process optimization and comprehensive control technologies along with a refrigeration system optimized to correspond with technical loads.
The building position and design has been chosen to allow easy future expansions, both laterally and vertically. The plant’s workflows will be optimized around isolator technology; not just in production but also in the compounding area, implemented to protect product as well as operators. Dassow’s laboratory area will also be isolator-equipped for microbiological testing and the whole plant will incorporate state of the art safety and environmental protection systems.
MRC Cleanroom Systems
AqVida is partnering up with MRC for clean room panels, since MRC has the industry leading cleanroom modular system manufactured from GRP (glass reinforced polyester).
Uncompromising approach on redefining state of the art, AqVida chose the one of the leading and premium cleanroom panels. The extra ordinary quality of these panels is a perfect fit for a facility which is ultra-modern and fulfills AqVida´s expectations on product and patient safety.
“It was the only cleanroom panel we found which could be repaired in situ which is extremely resistant and allowed us to optimize every single detail in our design.We are extremely happy to cooperate with MRC and to have chosen this superior panel. After all, if you buy a Ferrari you need a suitable garage for it. ”, Mr. Bär declared.
MVP lean production
The robotic technologies built into the Dassow MVP facility will allow AqVida to adopt the Just In Time (JIT) and lean production methods, bringing huge gains in speed, efficiency and responsiveness to oncology and biotech manufacturing. They will also allow AqVida to produce Minimum Viable Product (MVP) batches needed for clinical testing and regulatory proving.
Dassow, in the Greater Hamburg area, has provided an ideal location for the new MVP plant with excellent infrastructure and close to a university city with high skill and education base.
“The whole project is a novel technology approach – we are very happy to see that the use of robotic technology in our production increases flexibility, safety and maximizes the ‘Made in Germany’ factor that is one of AqVida´s main brand strengths”, said the company´s founder and CEO, Wolfgang Heinze.
AqVida GmbH is a German pharmaceutical company specializing in the development registration and distribution of finished dosage forms mainly in the oncology sector. It has developed a portfolio of medicines for treating the most common types of cancer.
AqVida’s expertise in the development, registration and supply of generic oncology products and biosimilars has made the company a leading partner in the pharmaceutical industry.
AqVida works alongside some of the major companies in the market of oncology products. Together with its partners AqVida has achieved substantial development and growth with its oncology portfolio.
After having developed and launched several oncology parenteral forms such as e.g. Paclitaxel, Docetaxel and Oxaliplatin, AqVida and its partner company, Benavis, have started development work on the ‘tinib’ series of molecular targeted anti-cancer molecules. AqVida is also developing other molecular targeted anti-cancer molecules, such as Sunitinib.
AqVida has an impressive track record in oncology, obtaining some 150 approvals for its products in several countries over the past few years. Well-established manufacturing and supply-chain have been the basis of AqVida’s leading presence in the high-quality German oncology market.
AqVida’s “Quality is Core” policy and very stringent drug safety expectations apply to all new product developments, which are all carried out in-house.
Jürgen Lehmberg, Commercial Director, AqVida GmbH
Wolfgang Heinze, CEO, AqVida GmbH
Tel: +49 40 380 37190