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.
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.
Early Phase Development Support for ADCs
Industry-Leading Expertise in Bioanalytical and Biosafety Testing
One of the first steps in the development of an ADC candidate is establishing the techniques and methods required for molecular analysis and characterization. BioOutsource, now part of the Sartorius Stedim Biotech Group, provides a range of bioanalytical tools. These include drug-antibody ratio (DAR) variant, residual solvent and residual cytotoxic analysis, along with additional bioassays and physiochemical assays to support both monoclonal antibody and ADC development throughout the development and commercial lifecycle. During the R&D and pre-clinical phases, most development activities focus around the conjugation step. Multivariate experimental designs allow firms to optimize this operation in order to achieve the required drug-antibody ratio by manipulating parameters such as reagent concentrations, pH, time, temperature and solvent concentration.
From Process Development Through to Equipment Selection
Sartorius’ Process Experts and Application Specialists are available to help you establish an ADC manufacturing process based upon our expertise in the area and platform approach to development and commercialization. In addition to the reaction unit operation(s), ultrafiltration and diafiltration, membrane chromatography, mixing, filtration, filling and freezing are all additional preparative unit operations to an ADC manufacturing process. Integrated Solutions Process Development Consultants use their knowledge of process development and clinical/ commercial-scale manufacturing to provide your scientists with invaluable advice on process design and equipment selection that will be suitable for cGMP manufacturing.
Fully Single-Use ADC Production Platforms
Lower Risk of Contamination and Greater Process Flexibility
The advances that the industry has made in single-use technology are allowing fully single-use ADC production platforms capable of the safe production of ADCs even with processes that require solvents. Single-use ADC production platforms significantly limit the risk of batch-to-batch and product cross-contamination. Companies can perform the process in a functionally closed system to provide protection to both the product and the environment. The development of single-use technology is enabling firms such as Bayer to install flexible ADC production capacity while limiting the need for significant capital investments utilities infrastructure.