Bioconjugate Development and Manufacturing
An Integrated Platform to Support Your Bioconjugate Development and Manufacturing Needs
Bioconjugates are a growing class of biopharmaceuticals that are developed by attaching two molecules together, of which at least one is a biomolecule. Examples of bioconjugates include antibody-drug conjugates (ADCs), pegylated proteins, siRNA conjugates and vaccine conjugates.
ADCs represent a significant area of clinical and economic growth for the biopharmaceutical market. ADCs combine the targeted specificity of a monoclonal antibody with a cytotoxic small molecule and are manufactured by linking these monoclonal antibodies to the highly toxic small molecules. There are hundreds of ADC candidates in development and analysts expect the market for these drugs to continue to expand. Production and analysis of varying quantities of ADC candidates is required to support research, process development, clinical development and commercialization of the molecules. Sartorius has an integrated platform of products and services to support ADC development and manufacturing needs from molecule inception through commercialization and is continuing to invest to mature this platform.
Webinar on Platforming Antibody Drug Conjugate
Single-use manufacturing technologies allow companies to quickly bring cGMP manufacturing capability online with less capital investment. In the webinar, we describe a robust and scalable platform for ADC process development and manufacturing that uses single-use technologies to accelerate development timelines and increase manufacturing predictability while decreasing scale up risks. In addition, case studies on membrane chromatography and crossflow filtration will be presented and the chemical compatibility of the materials described in the platform to solvents typically used in ADC process will be discussed.
Understand Your Process Economics
Achieve Reductions in Cost of Goods (COGS)
It is possible to understand the likely economics of the process, even at this early stage, using Sartorius’ expertise in cost modeling. This allows customers to determine the likely Cost of Goods attributable to post-conjugation processing. Firms can then make decisions regarding where in the process additional optimization studies may be required.
Companies may choose to transfer the process to a Contract Manufacturing Organization (CMO) for the production of clinical-grade ADC material. The Integrated Solutions team at Sartorius can support both clients and CMOs with any necessary engineering projects based on stainless steel, hybrid or single-use technologies.
