Introduction to Biopharmaceutical Manufacturing

COURSE DESCRIPTION

This 30-hr. course provides a solid foundation in the various methods, requirements and processes involved in the manufacturing and development of biopharmaceuticals, along with a look at emerging trends in the market. Attendees will gain an understanding of the how biopharmaceuticals are made, the regulatory requirements and support systems necessary to produce safe and effective biopharmaceutical therapeutics. The course covers topics including biopharmaceutical risk management, quality control, and maintenance of standards for production. By the end of the course, participants will have a solid grasp of the fundamentals of biopharmaceutical production.

■ Describe the steps involved in manufacturing biopharmaceuticals and their associated processes

■ Demonstrate an ability to follow the necessary steps to obtain a license for a biopharmaceutical

■ Describe necessary methods and requirements to maintain safe and effective biopharmaceutical products

■ Recognize the risks associated with biopharmaceutical production and manage them through quality assurance procedures

■ Analyze the different support systems necessary to ensure safe and effective biopharmaceutical production

■ Explain current trends and market factors shaping the biopharmaceutical industry

■ Introduction, Expectations and Course Overview

■ Module 1: Industry Review: Production Methods and Regulatory Considerations

■ Module 2: Bioprocess Overview

■ Module 3: Cell Growth and Upstream Technology

■ Module 4: Purification 1: Filtration/Chromatography

■ Module 5: Purification 2: Viral Clearance and Fill Finish

■ Module 6: cGMP-Brief Overview and Risk Management

■ Module 7: Aseptic Processing and Bioburden and Viral Risk Management

■ Module 8: Sterilization and Cleaning

■ Module 9: Multi-Use vs Single-Use Processing

■ Module 10: Facilities, Utilities, Support Services and Supply Chain

■ Wrap up and Certification Exam

The course is designed for individuals interested in entering the field of biopharmaceutical manufacturing, or those who are already working in the industry requiring a solid foundation in the basics, including those working in manufacturing roles, regulatory affairs, quality control, research and development. This includes process engineers, manufacturing technicians, quality assurance professionals, regulatory affairs staff, scientists, project managers and executives. The course is also ideal for recent graduates who have an interest in biotechnology or life sciences, as well as professionals who are looking to expand their knowledge and skills in biopharmaceutical manufacturing. By the end of the course, you will have acquired the skills and knowledge necessary to advance your career in this rapidly growing and dynamic field.

The course will utilize a range of assessment methods to evaluate your understanding of the material. These may include quizzes, online reviews, both group-based and online discussions and presentations. These methods will allow you to demonstrate your knowledge, interact with other students and the instructor, and receive constructive feedback on your progress throughout the course.

The course has been developed following the rigorous standards for content development and instructional design of Barnett International’s third-party accreditation provider. Thirty hours of formal continuing education units are provided. Additionally, the course is also one of three components of the Professional Biopharmaceutical Certification Program, and therefore qualifies toward one of three badges required to achieve full certification.