By recognizing the limitations of today’s production processes, the industry may be able to overcome the challenges, complexity, and high cost of manufacturing vaccines and viral vector-based therapies.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
The ADC field is in a transitional period. Older approaches to conjugate composition and dosing regimens still dominate the ADC clinical pipeline, but preclinical work is driving a rapid evolution in how we strategize to improve efficacy and reduce toxicity towards better therapeutic outcomes. In an indication of future directions for the field, antibody conjugates bearing non-cytotoxic small molecule payloads are being developed to reduce side effects associated with treatment of chronic diseases.
The importance of optimizing the chemical synthesis and formulation processes in complex molecule development.
Learn how a structured 3-step approach can help overcome the challenge of molecular characterization and a limited budget.
Smart bioprocessing uses bioinformatics, lab-scale processing, and analytics to create efficient and cost-effective production processes that can be verified at lab-scale before scale-up.
Read how this method resulted in higher purity and yield than what can be expected from a purification process based on salt precipitations and sucrose gradient centrifugation.
See how a combination of Biacore instruments, software, sensor chips, and kits supports the setup of screening and characterization assays and reduces assay development efforts.
Examples of how label-free biophysical binding assays are successfully employed in all steps in the immunogenicity workflow to ensure confident detection, confirmation, and comprehensive characterization of immune responses.
Review the use of Biacore for active concentration measurements, target binding, and Fc receptor (FcR) analysis along with the use of these assays for assessment of drug potency and stability.
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