Platform processes and effective risk assessments help overcome time and cost challenges. Successful biomanufacturing processes not only provide the desired product in high yield and purity, they ...

The long journey from cell culture to a purified monoclonal antibody (mAb) involves many sample processing steps, with clarification and filtration playing significant roles. However, clogs, complex ...

Researchers at the Institute for Bioscience and Biotechnology (IBBR) in Maryland in the U.S. have taken the first step towards developing a method for the production of a standardized monoclonal ...

Matt Taylor is a senior process development associate at KBI Biopharma, where he focuses on the design, optimization, and scale-up of purification processes for biopharmaceutical manufacturing. Matt ...

Many early workflows lack scalability, relying on temperature-sensitive steps, outdated purification tools or unnecessary customization. These design flaws often derail timelines and inflate costs ...

A therapeutic protein or monoclonal antibody (mAb) can be turned into an effective therapy and a revenue-generating product only if it can be efficiently filtered from the process stream. If a product ...

Several chromatographic resins are available for downstream purification. Monoclonal antibodies (mAbs) are a successful class of therapeutic products used increasingly in the past 15-20 years, but the ...

Development of robust purification processes requires significant time and resources. In addition, steadily increasing demands from regulatory authorities for better understanding and control of ...