Aesica, the global contract development and manufacturing organisation (CDMO), is pleased to announce the 20th anniversary of its site located at Zwickau in Germany. The facility possesses multiple solid oral dosage form technologies and service capabilities and has been integral in fast establishing Aesica as a leading provider of encapsulation services.
The immediate and controlled release technology enables Aesica to work with powders, pellets and tablets into capsules. The company has invested in technology and now has a range of encapsulation machines which are fully equipped with 100% weight control units. The modern machinery allows Aesica to utilise various capsule formats in addition to the capability to fill different materials into the capsules concerned.
Aesica Zwickau has emerged as a multi-purpose, advanced bulk production site for solid dose forms. It has the capability to conduct small scale trials and is equipped with a pilot scale laboratory that facilitates product and process transfer, formulation development and improvement of production processes. As well as encapsulation and tableting, Aesica Zwickau manufactures solid dose medicinal products through a variety of other technologies. This includes strong expertise in pelletizing, both layering of pellets and extrusion technology. Additionally, granulation capabilities, which range from high steer mixers, fluid bed granulation and drying and vacuum granulation technology are on offer. A broad range of bin blenders, tablet-presses and coaters enables the company to carry out blending steps as well as compression and film coating of tablets.
The site, which was first constructed as a manufacturing facility back in 1994, and later acquired by Aesica in 2011, now employs 200 skilled personnel. Aesica Zwickau is equipped with analytical capabilities ranging from analytical tests for raw materials and bulk products including microbiological testing, analytical methods development and validation. Moreover, product and process development is offered including manufacturing process transfer, formulation checks, improvement and validation of processes, , carried out in the company’s own pilot scale laboratory, and clinical trials supply. Recent technological developments have included the installation of new driam tablet coater technology and on-going investment in 2014 in new compaction machinery that fully complement existing capabilities.
Aesica Zwickau is fully compliant with a multitude of regulations including the Local German Health Authority in the EU, FDA, ANVISA, the Gulf Country Council and the Korean FDA. Currently, products manufactured at Zwickau are marketed in the EU, the US, the Middle East, Asia, Japan and South America including Brazil.
Tomasz Zytkiewicz, Site Director at Aesica Zwickau commented: “We are very pleased with the continued success of our site at Zwickau and what has been achieved to date during its first twenty years of operation. We consider this testimony to the quality of the site’s technology, facilities and personnel. In particular, our strong expertise in encapsulation and pelletizing of solid dose medicinal products has marked the site out as an important contributor to the overall success of the Aesica Group”.