ALS 418: Biopharmaceutical Quality Assurance and Control
Course Number: ALS 418
Course Name: Biopharmaceutical Quality Assurance and Control
Year: Second-year
Semester: Fall
No. Units: 0.5
Faculty/Instructor(s): Vince Anicetti
Description
Biotechnology has created more than 200 new therapies and production levels now routinely exceed metric tons for many antibodies. Product complexity has also increased as stem cell therapies have entered clinical studies and the first antilogous cellular therapies have recently been approved in the United States. In turn, ensuring product quality has grown in importance and complexity. Instances of product recalls and regulatory enforcement actions are frequent and result in supply shortages and significant loss of corporate reputation and value. Production of biotechnology products requires comprehensive quality standards and systems that meet global cGMP expectations and are based upon thorough scientific knowledge of the product and process.
Persons knowledgeable in the principles and practice of biopharmaceutical quality management are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance and control. Through a series of lectures and case studies this course will teach the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.
Prerequisites
ALS 333 or Instructor approval.
Topics Covered
- Responsibilities of management for quality review and oversight
- Principles and regulatory requirements of Good Manufacturing Practices
- Quality requirements for facilities, utilities, and equipment
- Modern quality systems for change control and compliant management
- Testing requirements to assess the safety, potency and purity of protein therapeutics and cell based therapies
- Scientific principles and regulatory requirements for establishing product specifications
- Development of efficient in-process testing strategies to ensure early detection of contaminates and microorganisms
- Quality control of raw materials and components
- In process testing requirements for cell culture processes and product recovery
- Utilization of manufacturing science in developing process validation programs which meet current regulatory requirements and expectations
- Application of risk assessment and management practices into the quality assurance program
- Development of self audit programs and management of regulatory inspections
- Compliant management, product recalls and counterfeit detection
- Principles for conducting investigations of process deviations and product quality problems
Learning Objectives
-By the end of this course the student will understand the scientific and regulatory basis for quality assurance and quality control in the biopharmaceutical industry.
- Students will be prepared for entry professional roles in biopharmaceutical quality control through instruction in specifications establishment, stability requirements, in-process control and microbial control of biopharmaceutical processes.
- Students will also be prepared for roles in quality assurance through instruction in the ICH Quality Guidance and international GMP's. Students will understand the fundamental concepts of product quality investigations, validation, and corrective/preventative actions.
- Students will learn the authority of, and how to interact with, regulatory agencies; with particular emphasis on inspection management and resolution of product quality issues.
- Last, students will understand roles and responsibilities of quality management positions through instruction in regulatory expectations for management, industry best practices, and case studies of management failures in quality.
Grading
Homework assignments and in class participation: 33%
Midterm: 33%
Final exam: 34%
Required Texts