A robust scale-down model development and process characterization for monoclonal antibody biomanufacturing using multivariate data analysis.

Quality by Design (QbD) principles are extensively applied in biopharmaceutical manufacturing processes to ensure the consistent production of high-quality biotherapeutic products through achieving a deeper understanding of critical process parameters (CPPs), critical quality attributes (CQAs), and their interrelationships as well as establishing appropriate process control strategies. To do so, herein, we involve utilizing advanced multivariate data analysis (MVDA) in the context of scale-down model (SDM) development and validation as an ingenious approach for enhancing process efficiency and achieving greater regulatory compliance in the biomanufacturing of biologics. First, MVDA was applied to develop and evaluate several SDMs under various production conditions, including changes in scale-dependent parameters.

Improved Bone Regeneration With Multiporous PLGA Scaffold and BMP-2-Transduced Human Adipose-Derived Stem Cells by Cell-Permeable Peptide.

Objective: Currently, much work has focused on the engineering of bone using adipose-derived stem cells (ADSCs), which differentiate into osteogenic cells. This study was conducted to assess the bone-regenerating capacity of ADSCs with genetic modification.

Materials And Methods: ADSCs were cultured and transduced with recombinant adenovirus-expressing bone morphogenetic protein-2 (rAd/BMP-2).