Continuous Manufacturing Development, Production and Quality

Continuous Manufacturing Development, Production and Quality

Berlin, Germany

Course No 17056


Costs

Non ECA Member: EUR 1790,--
ECA-Member: EUR 1590,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

(All prices excl. VAT)

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Florian Capito, Sanofi
Dr Nick Lee, Health Product Regulatory Agency (HPRA), Ireland
Britta Manser, Pall Biotech
Ilse Nuyens, Janssen Pharmaceutica
Dr Harald Stahl, GEA
Dr Kelly A. Swinney, Vertex
Ilse Vannuffelen, Janssen Pharmaceutica
Dr Christoph Wabel, Pfizer
Martin Warman, Martin Warman Consultancy
Frank Witulski, MSD

Moderator: Dr Moheb Nasr, NPRC and formerly FDA

Objectives

It is the aim of this conference to show how a transition from batch to continuous manufacturing can look like. Questions regarding technology, process development and GMP/Quality Assurance and Regulatory Affairs will be discussed.

Background

Solid dosage forms are still the most common dosage form, first and foremost tablets without any pioneering developments in the recent years. But driven by only a few pharmaceutical companies more and more of the global players started to invest in continuous manufacturing (CM). Companies like GSK, Pfizer; Johnson & Johnson and Vertex have been in the news lately. But also the Biotech Industry started to invest in CM. Upstream Processing is the more common area, but lately also Downstream Processes have been developed to be run continuously.

A shift from batch to continuous manufacturing could be one of the largest paradigm changes since the system of validation & qualification came up years ago.
Continuous manufacturing is data driven and by gaining this flood of information two topics become very important: process control and process monitoring. A vast amount of data has to be evaluated in order to control the process and to decide whether material can be collected or has to be rejected. This fundamental shift is also a major challenge for the Quality Unit. The Quality Management System has to be adapted to also cover continuous processes.

Regulating authorities, first of all the FDA, also encourage the transition from batch to continuous production. They expect an increase in product safety while equipment suppliers promote a decrease of production costs. But with a continuous mode of operation new questions raise:
  •  How should a batch be defined? Is there a difference between lot and batch?
  •  What new risks does a continuous process involve?
  •  How can a continuous line look like?
  •  How can a continuous process be kept in a controlled state?
  •  How is a continuous system validated?
  •  How to determine the ResidenceTimeDistribution – what about material traceability?
  •  How should deviations in a continuous process be handled?
  •  How should equipment cleaning and maintenance be scheduled?
  •  Which documents do the authorities require for approval of continuous processes?
Listen to companies who already did the transition and learn how they answered the questions above.

Target Group

This conference is directed at
  •  Decision makers dealing with the question whether continuous manufacturing is suitable
  •  Executives from development, engineering, production and QA responsible for the implementation of continuous manufacturing
     

Programme

Regulatory considerations of continuous manufacturing

Global Regulatory Implementation 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:
    • mAb A
    • mAb B
  •  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

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