AbbVie Biologics Contract Manufacturing

AbbVie Biologics Contract Manufacturing

AbbVie Biologics Contract Manufacturing is the microbial CMO – your complete and best choice for contract manufacturing of therapeutic proteins, vaccines, and Live Microbial Products. AbbVie Contract Manufacturing services cover Cell line development, Fermentation biotechnology, cGMP manufacturing, Process optimization, Analytical characterization, and Validation.

We offer our customers added value with outstanding E. coli technologies that increase significantly in the bioprocess efficiency and so reduce the cost of goods. Excellent project management is an important and determining factor in the success of any project we embark on. Thus, dedicated project management is our top priority.

Why Choose AbbVie Biologics Contract Manufacturing

Process Development

Process development is the link between research and the successive commercial production of biopharmaceuticals. Our goal is to develop a cost-effective and robust manufacturing process that can be validated and yield maximum quantities of high-quality products while observing all processes and product specifications.

With nearly 30 years of experience as a pharmaceutical developer and manufacturer and hundreds of accomplished projects for our customers across the globe, AbbVie Contract Manufacturing has the competence to develop processes that satisfy our customers’ demands for rapid availability of clinical materials, while putting into consideration the long-term demands on commercial production processes.

At AbbVie, we serve customers from different locations such as Germany, Ireland, Italy, the USA, and Puerto Rico. Our Bioprocess Development department focuses mainly on process development, material supply for preclinical trials, strain/analytical development, process transfer, and process characterization.

GMP (Good Manufacturing Practice) Manufacturing

AbbVie Contract Manufacturing’s multi-purpose GMP facilities in our locations offer pharmaceutical contract manufacturing capabilities for microbial-based biopharmaceuticals worldwide. Our supply is according to the highest quality standards. Our clients also enjoy our service offering (GMP cell banking, development, bulk drug substance, drug product production, etc), which also comes with program flexibility, reduction in time, and of costs.

With many hundreds of released batches for our customers across the globe, we have years of proven expertise in the production of soluble and insoluble recombinant proteins (including inclusion bodies and re-folding capabilities), wild-type microbial antigens, microbial vaccines, polysaccharides (including activations and conjugations capabilities) as well as Live Microbial Products.

Fill & Finish

AbbVie Contract Manufacturing has nearly 30 years of experience with aseptic filling and lyophilization of a broad range of biopharmaceuticals. Our fill & finish suite in Sligo, Ireland can be used for filling your bulk drug substance, and also as a stand-alone service offering. We ensure the processes used at AbbVie for the manufacturing of our client drug product batches follows with EMA standards and FDA guidelines.

Microbial Technologies

We offer innovative technologies for the efficient and cost-effective production of biologics, also including plasma half-life extension, if desired. According to the properties of the target protein, we recommend the most suitable expression strategy using technologies like ESETEC and FOLDTEC.

Quality Management

At AbbVie, we work in line with pharmaceutical GMP to ensure the top quality required for compliance to clinical studies or market approval by the American FDA (Food and Drug Administration) or the European EMA (European Medicines Agency). The biopharmaceutical manufacturing facilities at all our company sites are FDA and EMA certified.