Regulatory considerations of continuous manufacturing
A Global Perspective on Regulatory and Quality Consideration of Continuous Manufacturing
- Impact of current regulatory system on implementation of CM
- Points to consider prior to the implementation of CM
- Filing requirement and expectations – Global perspective
- Remaining regulatory challenges
- Future regulatory guideline – ICH and regional
Authorities’ expectations regarding continuous processes
- Critical elements & considerations when filing an MAA
- Regulatory guidelines and assistance in the EU
Development & control of continuous Processes
Determining the extent of RTD and implementing as part of control strategy
- Explanation of control strategy complexity pyramid
- Introduction to performance based control
- The role of process dynamics in performance based control
- When and where to apply residence time distribution (RTD)
- Setting action limits based on performance based control
- Using performance based control data as part of a real-time release strategy
Real Time Release Testing and Drug Product Continuous Manufacturing
- Implementation considerations for a control strategy including RTRT will be reviewed.
- Differences between IPCs and RTRT in drug product continuous manufacturing will be discussed.
- Approved real time release testing approaches will be described.
- Possible next steps in the evolution of RTRT and CM will be presented.
Quality Assurance for continuous Manufacturing
The Quality Journey to Continuous Manufacturing
- Changes in the in the Quality Management System
- Implementing Control strategy
- Preparing for Real Time Release
Installation of a CM line at Janssen from a Quality point of view
- Equipment Qualification
- Handling deviations
- Implementation of the CM process in an existing development plant
Technology & Equipment
Process Solutions for OSD manufacture
- Continuous Solid Dose Manufacturing- Review of Process Options
- When to use which process options
- Review of
- Lose in Weight Feeding
- In line mixing
- Continuous wet granulation and drying
- Tablet Compression
- Continuous Coating
Continuous Processing for Biopharmaceuticals
- Overview of continuous bioprocessing concepts for biopharmaceutical products
- State-of-the-art in continuous bioprocessing concepts
- Possibilities and challenges of continuous manufacture
Pharmaceutical Case Studies
Case Study Sanofi: Use of continuous chromatography for downstream processing of biologics – benefits and challenges
- Review typical downstream purification process for therapeutic antibodies
- Application of continuous chromatography in downstream processing of therapeutic antibodies
- Benefits regarding cost of goods, throughput for different stages of the project – clinical supply vs. commercial supply
- Presentation of two case studies showing upscale of processes from development labs to production facility:
- Challenges during use of continuous chromatography, e.g. stability of load material,
- sanitization of resins, bioburden
- Application to fed-batch processes vs. perfusion processes
- Knowledge sharing based on implementation under GMP at sanofi-aventis
Case Study Pfizer: Continuous OSD Manufacturing
- Reasons for Continuous Manufacturing
- Regulatory Specifics
- Special Consideration during Development and Routine
- Controlling continuous processes
- Handling of deviations during production
Case Study MSD: Continuous Manufacturing using Direct Compression
- Experiences with developing, commercializing, and filing MSD’s first CM product.
- Use of an RTD Process Model for Rejection in a CDC process.
- Look-ahead towards future innovations with Continuous Manufacturing