Protecting Patients: Viral Clearance and Safety Strategies for mAb Production
Guided Learning at Your Own Pace with Experts
This course will provide you with the necessary scientific background on Viral Clearance and Safety for mAbs and its role in mAbs manufacturing, strengthening your understanding about viral validation studies and regulatory guidelines that deals with it and methods used for viral clearance in upstream and downstream process.
It includes:
- Mix of self-paced and instructional units with 4 - 6 hours of learning per week (16 – 24 hours in total) over 4 weeks
- Interactive collaborative platform to facilitate knowledge exchange
- Limited synchronous activities allow participation from across the globe
Duration:
16 - 24 h
Self-Learning Program Available From:
Registration is open. Register your interest by filling out the form at the bottom of this page.
Who Should Attend
Professionals from various domains in the biopharmaceutical industry can attend this course:
- Researchers
- Process Development specialists & experts
- MSAT Professionals
- Process Engineers
- Manufacturing executives & managers
- Regulatory affairs professionals and managers
- Quality control analysts and managers
- Quality assurance analysts and managers
- Validation professionals
- Fluent English is essential for optimal learning
What You Will Learn
- Understand the role of model viruses in viral clearance study
- Identify the potential source of viral contamination
- List the regulatory guidelines and requirements
- Get an understanding of viral clearance studies
- Learn viral removal methods in bioprocessing
- Understand the viral detection and identification methods
- Get an understanding of scale-down models, viral clearance studies and limitations, worst-case studies, and process evaluation
How You Will Learn
This self-paced online course consists of learning units, allowing you to fit learning into your work schedule. This course incorporates online forums, assignments, and the use of an interactive and collaborative platform to enable participant knowledge exchange.
Focus Topics & Agenda
How is the Sartorius Academy’s Protecting Patients: Viral Clearance and Safety Strategies for mAb Production program structured?
Pre-Learning | Virus
|
Module 1
|
Module 2
|
Module 3
|
Module 4
|
Module 5
|
Learning Modules
- Sources of Viral Contaminations
- Introduction
- Where can virus contamination come from ?
- Endogenous viruses
- Adventitious Viruses
- The consequences of Viral Contaminations
- Regulatory Requirements
- Highlights of different regulatory guidelines
- Three fundamentals of virus safety
- Regulatory expectations.
- When virus clearance validation study will be done?
- Regulatory guidelines
- Scale-Down Models
- Guidelines for Scale down model
- Scale down model
- Scale down model Qualification
- Scale down model for Purification steps.
- Viral Clearance.
- What is viral clearance?
- Why do we care about virus safety?
- What drugs require virus clearance?
- Scope of virus safety concepts
- Viruses Used in Viral clearance studies.
- The Virus Panel
- TSE (Transmissible Spongiform Encephalopathy)
- Viruses in viral clearance studies.
- The right virus panel is essential
- Selection of viruses
- Examples of viruses which have been used in viral clearance studies
- Scope of Viral Clearance Study
- Test Scope is Adopted to Development Phases
- Different in the Scope of Testing for feasibility & GLP Studies
- Virus Clearance Studies.
- What is Virus Clearance Studies
- Overview of Virus Clearance Studies
- Spiking Study to validate virus removal for each step
- Determination of Viral Clearance Capacity
- Log Reduction Value
- Virus clearance during Manufacturing
- Cumulative LRV Calculation
- Timeline
- Study Plan
- Pre-Tests
- Process
- Report & Review
- Study design Phase I
- Study design Phase III
- Limitation of virus Clearance Studies
- Process Evaluation
- Worst Case Conditions
- Overview
- Affinity / Protein A chromatography
- Low pH Treatment
- Anion Exchange Chromatography
- Virus Filtration
- Testing for viruses
- Raw materials
- Cell Banks
- During Production
- On what Rationale are Cell lines Acceptable?
- Virus Detection in Unprocessed Bulk
- Regulatory Guidelines related to Virus Testing
- Virus Detection and Identification Assays
- Quantitative Virus Assays
- Virus Clearance Upstream
- Viral Safety in Upstream Process
- Virus Clearance Technologies in Upstream
- Filtration
- High Temperature Short Time Treatment (HTST)
- UV-C radiation
- Viral Clearance Downstream
- Inactivation Methods
- Low pH Treatment
- Challenges
- Solvent / surfactant method
- Low pH Treatment
- Removal methods
- Overview
- Protein A chromatography
- Anion Exchange Chromatography
- Viral Filtration
- Inactivation Methods
