Domenico Annese, Johnson & Johnson
Alessandro Cassetti, Johnson & Johnson
Steve Hammond, Steve Hammond Consulting
Dr Martin Maus, Boehringer Ingelheim Pharma
Dr Harald Stahl, GEA
Frank Witulski, Merck US
Jan Verelst, Siemens
It is the aim of this event to show how a continuous manufacturing process for oral solid dosage forms can be developed and set into operation. Questions regarding materials, technology, process controls and GMP/Quality Assurance will be discussed and answered.
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 Johnson & Johnson, Vertex, Pfizer and Merck work intensively on the development of continuous processes with some products already approved. This change from batch-to-batch to the continuous mode of operation is one of the largest paradigm changes in the pharmaceutical industry ever.
Continuous manufacturing is data driven and by gaining this flood of information two topics become very important: process control and process monitoring. The residence time of the materials processed becomes another important quality aspect. Time now also is the most important parameter for scale-up, not the volume of the equipment any more.
So a large 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. Pharmaceutical companies emphasis the savings of time and materials needed during the development and transfer phases.
But with a continuous mode of operation new questions rise:
- How should a batch be defined? Is there a difference between lot and batch?
- What are the prerequisites for the development of a continuous process?
- What new risks does a continuous process involve?
- How can a continuous manufacturing line look like?
- How can a continuous process be kept in a controlled state?
- How is a continuous process 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.
This conference addresses specialists and executives working in the fields of pharmaceutical development, manufacture and quality assurance as well as technicians, planners and plant designers, especially those involved in the set up of continuous lines for manufacture of oral solid dosage forms.
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The recent Continuous Manufacturing Landscape
- Introduction to Continuous Manufacturing
- From Early ideas to current solutions
- Reasons to go Conti
- A brief market overview- unit operations, suppliers & users…
- Different approaches to CM
- Direct Compression
- Roller Compaction &Tableting
- TSG/Fluidbed Granulation & Tableting
Prerequisites: how to start with Continuous Manufacturing
- Is a new product suitable for CM?
- What are the business drivers for this product and how can CM meet those goals?
- Evaluation of material properties for CM (e.g. flow, feeding variability, etc.)
- Process modelling
- Control strategy considerations
Using DoE for the development of continuous processes
- Basis of using DoE in process development
- How to start
- Data Evaluation
- Example: continuous twin screw granulation (TSG)
Measurement points and sensor interfaces
- PAT techniques
- Mass balance models
Integrated PAT data management on continuous pharmaceutical lines
- Integration of (different) PAT tools into an (existing) automation environment
- Structured data management of data from different data sources
- Real-time monitoring of CQA’s
- Product diverting & Advanced Process Control
- Some use cases
Development of a control strategy
- Different approaches
- RTD and its Determination
- Material traceability
- Risk analyses
Real time release
- What does this mean?
- Registered Examples
J&J experience: CM from equipment qualification to regulatory submission
- Overview of the three technologies used at J& J Pharma
- Wet Granulation
- Dry Granulation
- Direct compression
- SDNV approach for qualification
- Control strategy – practical aspects
- PAT Integration
- CPPs Monitoring
- Rejection strategy
- Cleaning & Change Over challenge
- Experiences from Regulatory submission
Case Study Merck US: Continuous Manufacturing using Direct Compression
- Experiences with developing, commercializing, and filing Merck’s first CM product.
- Use of an RTD Process Model for Rejection in a CDC process.
- Look-ahead towards future innovations with Continuous Manufacturing