Many early workflows lack scalability, relying on temperature-sensitive steps, outdated purification tools or unnecessary customization.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 ...

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 ...

A novel continuous monoclonal antibody (mAb) production process could help drug firms reach quality goals and cope with changing capacity needs, according to CDMO Fujifilm Diosynth Biotechnologies.

DURHAM, N.C.--(BUSINESS WIRE)--KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), announces a manufacturing contract ...

Monoclonal antibody and viral vector manufacture share similarities, but vector scale up faces unique challenges. Scale up in gene therapy manufacturing currently revolves around viral vector scale up ...

Successfully scaling up monoclonal antibody (mAb) production can be a significant challenge. As workflows scale toward clinical and commercial production volumes, developers need to be confident that ...

Cell-line development enhances biopharmaceutical production capacity and quality, but complex biologics like bsAbs and ADCs present new challenges.

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...