Cell Therapy Manufacturing and Quality Control: Current Process and Regulatory Challenges

Cell Therapy Manufacturing and Quality Control: Current Process and Regulatory Challenges

Advanced cellular therapy products represent a new paradigm of bio-regenerative medicine using MSCs as one of the cell populations to meet with unmet medical need. The application of MSCs for cellbased therapies is in cognitive phase of development and their ability of multipotency, immunomodulatory, proliferation capacity and genomic stability are critical for achieving therapeutic success. On...

Regulatory and Biosafety Challenges for Vaccines

The global regulatory plan for vaccines provides a unique opportunity to develop safe and effective ones with assured quality. Methods used by regulators address challenges of new products and technologies and also increase understanding of benefits and risks of existing products. First, the laboratory-based regulatory sciences evolve correlates of immunity and safety; or improve the product ch...

Manufacturing Processes and Process Control

effect of seed priming and irrigation regimes on yield,yield components and quality of safflowers cultivars

این مطالعه در سال 1386-87 در آزمایشگاه و مزرعه پژوهشی دانشگاه صنعتی اصفهان به منظور تعیین مناسب ترین تیمار بذری و ارزیابی اثر پرایمینگ بر روی سه رقم گلرنگ تحت سه رژیم آبیاری انجام گرفت. برخی از مطالعات اثرات سودمند پرایمینگ بذر را بر روی گیاهان مختلف بررسی کرده اند اما در حال حاضر اطلاعات کمی در مورد خصوصیات مربوط به جوانه زنی، مراحل نموی، عملکرد و خصوصیات کمی و کیفی بذور تیمار شده ژنوتیپ های م...

Challenges and opportunities in biopharmaceutical manufacturing control

The total sales of biopharmaceuticals have been steadily increasing for decades with growing approval of new drug products, especially for monoclonal antibodies. This trend motivates the development of deeper understanding and advancement of biopharmaceutical manufacturing operations. This article describes opportunities, needs, and challenges in process control and operations for biopharmaceut...