Process Development in Biopharmaceuticals
( 25 Modules )

Module #1
Introduction to Process Development in Biopharmaceuticals
Overview of the biopharmaceutical industry, importance of process development, and course objectives

Module #2
Biopharmaceutical Product Development Paradigm
Understanding the product development lifecycle, from discovery to commercialization

Module #3
Regulatory Framework for Biopharmaceuticals
Overview of regulatory agencies, guidelines, and requirements for biopharmaceutical product development

Module #4
Cell Line Development and Selection
Principles of cell line development, selection, and characterization for biopharmaceutical production

Module #5
Cell Culture Media Development
Design, optimization, and characterization of cell culture media for biopharmaceutical production

Module #6
Upstream Process Development
Design and optimization of upstream processes, including bioreactor design and operation

Module #7
Downstream Process Development
Design and optimization of downstream processes, including purification and recovery

Module #8
Chromatography for Biopharmaceutical Purification
Principles and applications of chromatography in biopharmaceutical purification

Module #9
Viral Clearance and Inactivation
Strategies and techniques for viral clearance and inactivation in biopharmaceutical production

Module #10
Formulation and Fill-Finish Operations
Design and optimization of formulation and fill-finish operations for biopharmaceutical products

Module #11
Process Analytical Technology (PAT)
Principles and applications of PAT in biopharmaceutical process development and manufacturing

Module #12
Quality by Design (QbD) and Design of Experiments (DoE)
Principles and applications of QbD and DoE in biopharmaceutical process development

Module #13
Risk Management and Failure Mode Effects Analysis (FMEA)
Principles and applications of risk management and FMEA in biopharmaceutical process development

Module #14
Scale-Up and Technology Transfer
Principles and best practices for scale-up and technology transfer in biopharmaceutical process development

Module #15
validations and Qualification
Principles and applications of validation and qualification in biopharmaceutical process development

Module #16
Current Good Manufacturing Practices (cGMP) and Compliance
Principles and applications of cGMP and compliance in biopharmaceutical manufacturing

Module #17
Biopharmaceutical Process Modeling and Simulation
Principles and applications of process modeling and simulation in biopharmaceutical process development

Module #18
Single-Use Technologies in Biopharmaceutical Manufacturing
Principles and applications of single-use technologies in biopharmaceutical manufacturing

Module #19
Continuous Manufacturing in Biopharmaceuticals
Principles and applications of continuous manufacturing in biopharmaceuticals

Module #20
Case Studies in Biopharmaceutical Process Development
Real-world examples and case studies of successful biopharmaceutical process development

Module #21
Emerging Trends and Technologies in Biopharmaceutical Process Development
Overview of emerging trends and technologies in biopharmaceutical process development

Module #22
Process Development for Biosimilars
Unique challenges and considerations for process development of biosimilars

Module #23
Global Regulatory Requirements for Biopharmaceuticals
Overview of global regulatory requirements for biopharmaceuticals, including EU, US, and Japan

Module #24
PAT and QbD in Biopharmaceutical Regulatory Submissions
Role of PAT and QbD in biopharmaceutical regulatory submissions

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Process Development in Biopharmaceuticals career

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Process Development in Biopharmaceuticals ( 25 Modules )

Process Development in Biopharmaceuticals
( 25 Modules )