Inline Buffer Formulation: A Facility Operations Game Changer

By George Flores, technical solutions manager, Asahi Kasei Bioprocess

To successfully manufacture protein-based therapeutics, buffer strategy — from preparation to formulation to storage — is essential. Buffers are critical throughout manufacturing: maintaining pH in the upstream, managing purification conditions in the downstream, and optimizing stability throughout formulation and storage. To help ensure scalability on the pathway to clinical and commercial use, drug manufacturers must identify flexible and cost-effective buffer management approaches.

Traditional buffer preparation requires the manual mixing of buffer solutions in large batches to store in tanks prior to use. Though this strategy is functional, it comes with inherent challenges, including heavy labor and time commitments as well as the need for ample storage space. Inline buffer formulation (IBF) has emerged as an appealing replacement thanks to its ability to prepare precise buffer quantities in real time throughout production. Download the full whitepaper to explore how IBF is enabling agile, efficient, and scalable buffer management.