The European Commission's proposed revised pharmaceutical legislation is set to impact the pharmaceutical industry and may require innovative developers to revise their plans. This legislation aims to replace existing regulations and ensure the availability of safe and effective medicines, affecting all medicines and regulatory processes.
Examine the importance of glycosylation in antibodies and its impact on their properties and functionality, emphasizing the need for monitoring glycan content during antibody manufacturing, especially in biosimilar development. The example of rituximab and its biosimilars is used to illustrate the significance of minor differences in glycosylation.
This article discusses the use of ligand binding assays and chromatographic methods for pharmacokinetics assessment of monoclonal antibodies. Review the advantages of these methods over ELISA as well as the use of fluorescence and electrochemiluminescent detection methods.
Explore Mabion's new installations in upstream development, new bioreactors, as well as downstream development and fill/finish. This state-of-the-art EU-GMP-certified facility is staffed by a team of 250 professionals and as of 2023 is focused solely on providing CDMO services to its clients.
Our team possesses extensive knowledge of various biologic molecules. Learn how leveraging the expertise and flexibility of a partner empowers you to ensure regulatory compliance from the outset, with thorough characterization starting at the earliest stages.
Mabion specializes in the production of sterile biotechnological products in a manufacturing plant that meets the requirements of GMP. We are committed to integrating and commercializing scientific achievements in order to develop a biological medicinal substance based on mammalian cell cultures.
