Recognizing the need to enhance your bioprocess is just the start—determining the best path forward is the real challenge. Find answers to common questions, and gain insights that can support your next steps, whether advancing to a new clinical phase, constructing a new facility, or fine-tuning an existing process to keep pace with market shifts.
The ability to scale seamlessly between bioreactor sizes helps to ensure product quality and de-risk scaling activities. Here, we provide an overview of the theory of scaling, present workflows and strategies, discuss which data are needed for successful scaling, and present case studies that use our web-based scaling tool.
The subcutaneous (SC) delivery of mAbs offers advantages over intravenous infusion. However, to meet the required dosage within the limited volume of SC administration, formulations often must be highly concentrated. Discover how you can achieve a final mAb concentration above 200 g/L while maintaining critical quality attributes.
Having options is advantageous, but navigating the numerous choices for capacity expansion can be overwhelming. To simplify your scale-up planning, whether you are ramping up for clinical trials or preparing for large-scale GMP production, here is a variety of options tailored for a complete mAb process, available at both pilot and production scales.
