Wuxi Griffin
Paving Way For Secured Fill And Finish Process

Fill-finish is an important aspect of the biopharmaceutical manufacturing process and even minor errors can lead to the biggest nightmare of production failure, resulting in a loss on an already expensive product. The prevalent challenges of maintaining a contaminant-free fill-finish environment are numerous and complex, ranging from cleanroom maintenance to equipment sterilization to aseptic lyophilization and stoppering. Therefore in a production context, biopharmaceutical companies are necessitated to have a high level of flexibility and efficiency. By leveraging Innovative tools and technologies many forward-thinking manufacturers aim to meet those rising complexity.

With an average of 15 years of extensive experience in the pharmaceutical business, Wuxi Griffin, based in China, serve as an international contract manufacturing organization of injectable pharmaceuticals motivated to reduce such complexities. Their expertise lies in the aseptic fill and finish of biopharmaceuticals, including monoclonal antibodies and small-molecule drugs in vials and ampoules. By providing RABS(Restricted-access barrier system) and Isolator-based filling technology in their GMP(Good Manufacturing Practice )compliant fill and finish facility, Wuxi Griffin offers to fill and finish services with great flexibility to meet client’s needs. From clinical trials to commercial scale-up, they provide fill and finish production that complies with global GMP standards. Henceforth, Wuxi Griffin’s batch sizes range from 2 to 150 liters, with the possibility of 500 liters in the future.

Wuxi Griffin is a joint venture between Wuxi Fortune Pharmaceutical Co LTD in China and SialoCarb AB in Sweden and aims to establish a long-term partnership built on trust and mutual benefits with all of the stakeholders. The company offers customized fill and finish services to meet their client’s needs. In addition, Wuxi Griffin adopts a transparent approach with its partners. As a result, the client will maintain control over the process and their products, whilst having complete project flexibility. Wuxi Griffin guides the formulation process, which is critical to a drug’s safety and reliability. As a result, they carefully create the client’s medicine by the client’s established specific demands. Wuxi Griffin employs a single-use approach to reduce the possibility of contamination during the filling process. In the case of ampoule filling, however, they use both a traditional formulation technique and a single-use approach.

To ensure the sterilization of the finished medicine, Wuxi Griffin carries out the terminal sterilization stage with the utmost precision. In the end, this means that the microbiological contamination in the filled ampoule is eliminated. Before deciding if the terminal sterilization method is appropriate for the product, they even assess the heat stability of the materials.

Apart from commercial manufacturing and final product sterilization, Wuxin Griffin provides a full range of specialized packaging and labeling services that will assure the safety of the client’s product. The company helps the client to choose the right primary and secondary packaging for their medicine formulation. Additionally, each of their finished vials and ampoules undergoes a 100 percent visual inspection process. Those that do not meet the requirements are discarded. In brief, visual checks are an important stage in ensuring the filled product’s safety.

To meet rising productivity demands, efficiency, and safety, Wuxi Griffin has recently completed their state-of-the-art filling facility In Wuxi, China. The company has developed an integrated fill and finish equipment solution For the filling process and also introduced their aseptic filling activities to take place in a Grade A isolator with a Grade C backdrop and a RABS area. Three filling suits have been installed in the manufacturing plant thereby possessing the freedom and resources to tailor the client’s products according to exact demands and specifications.

Wuxi Griffin has carved out a direction to establish efficient communication and build closer partnerships with all of their customers, by opening a European marketing and sales office in Sweden. Furthermore, their presence in the West will bring them closer to many of their clients and create awareness of Western culture and traditions. In the end, this will result in smooth implementation of their clients’ needs. Being a customer-oriented organization, Wuxi Griffin is firmly focused to provide exceptional customer service