Tag: <span>preclinical manufacturing</span>

Using a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

The development and manufacturing of advanced breakthrough cell therapies presents a wide variety of complex challenges that include:
• delivering the medical science, from research all the way through product development and clinical testing, to the patient population;
• understanding and defining the product’s modes of activity and the cell’s attributes necessary to attain therapeutic benefit and safety;
• overcoming significant manufacturing, logistical, and cost of goods issues associated with using attachment-dependent bioreactor systems; and
• defining product release challenges associated with rapidly delivering an effective product to the patients.

Read MoreUsing a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

amps appropriate manufacturing practices cell therapy cellular therapy cost of goods cqas critical quality attributes preclinical manufacturing process lifecycle paradigms risk-benefit structure