Continuous Manufacturing of Oral Solid Dosage Forms Advanced Pharmaceutical Production: GMPs, Development & Technology

Continuous Manufacturing of Oral Solid Dosage Forms

Cascais, Portugal

Course No 20938

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.

 

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Speakers

Selma Celikovic, RCPE
Prof Dr Alastair Florence, CMAC
Dr Shashwat Gupta, Eli Lilly
Dr Jim Holman, GEA
Dr Adrian Kape, Glatt
Dr Sau (Larry) Lee, FDA
Prof Dr Jim Litster, University of Sheffield
Dr Rapti Madurawe
Dr Robert Meyer, MSD
Dr José Luís Santos, Hovione
Wayne Sinclair, TEVA
Jesus Torres, Thermo Fisher Scientific
Jan Verelst, Siemens.

Objectives

The objective of this event is to share the practical experience and the potential of continuous manufacturing for oral solid dosage forms, also known as continuous tableting. Through the Expertise of leading individuals in academia, industry, and regulation, the following objectives will be achieved:
  • Regulatory Requirements: The regulatory landscape will be provided by experts, who will discuss Regulatory Processes for New Chemical Entities and Post Approval Change Management Plans (PACMPs).
  • Industry Experience: In this part of the event, the practical experiences of pharmaceutical manufacturers who are embracing continuous manufacturing are highlighted. Insights will be shared from those with significant experience in the field, including Innovators and generic companies that have adopted continuous tablet production, and CDMOs that are developing the expertise and capabilities to provide access to the technology to the entire industry.
  • Technological Opportunities: The technology Providers that synergistically enable the deployment and operationalization of continuous tableting will discuss their efforts and capabilities in detail. This includes the understanding of unit operations and their integration into continuous mode, and process control system enhanced with PAT, to establish an ecosystem of real-time monitoring and advance process control running effective and efficient processes.
  • Latest research: The event will offer a chance to explore recent research that combines both theoretical and practical aspects of continuous tableting. During this session, it will be shown how the utilization of models, data-driven approaches and seamless integration contribute to improving the effectiveness of continuous tableting development and production.

Background

The pharmaceutical manufacturing landscape is undergoing a significant shift, with continuous manufacturing emerging as a catalyst for change. Historically dominated by batch processes, this transition towards continuous manufacturing holds the promise of improved efficiency, enhanced quality, greater operational flexibility and accelerated development. A select group of pioneering companies alongside leading academic institutions are at the forefront of this transformation and will share their practical experience infusing innovation around continuous tableting into the industry.
Regulatory bodies, namely the FDA, are actively promoting the transition from batch to continuous production. Their Primary expectation is an enhancement of product quality, faster development, and reliable, robust, and agile supply. Pharmaceutical companies emphasize the substantial savings in time and materials during development and transfer phases that are a result from the enhancements that continuous manufacturing offers. The essence of continuous manufacturing lies in data-driven operations. As a flood of information becomes available, two critical areas gain prominence: process control and process monitoring. The residence time of processed materials assumes significance as a quality factor. Notably, time has surpassed equipment volume as the pivotal parameter for scaling up operations.
The evaluation of substantial amounts of data is imperative for effective process control and the determination of whether materials meet the required standards or should be discarded. Besides production and technology, the quality unit is decisively affected by these changes, as the entire quality management system must be adapted to include continuous processes.

Target Group

This conference addresses specialists and executives working in the fields of pharmaceutical development, manufacture and quality assurance, especially those involved in the setup of continuous lines for the manufacture of oral solid dosage forms. Executives from plant construction and engineering companies are also the target group of this event.

18 April 2024: Visit of the Hovione Sites in Lisbon
Hovione Site Visit – Continuous Tableting Facilities

As part of the conference, registered participants will have a unique opportunity to visit Hovione's cutting-edge labs and manufacturing facilities in Lisbon, where research, development, and manufacturing activities take place.
In the labs, participants will gain access to Particle Engineering facilities, explore some of the most advanced analytical PAT tools, and get a close look at the specialized equipment used in continuous tableting development. They will also have the chance to observe analytical and process development operations in an engaging hands-on workshop, guided by Hovione experts.
During the visit to the manufacturing facilities, participants will witness a state-of-the-art facility in action, showcasing a continuous direct compression production unit. Additionally, they will have the opportunity to see and compare with an equivalent batch process.
Please note that availability for this exclusive site visit is limited, so securing your spot early is highly recommended to ensure you don't miss out on this opportunity to experience Pharmaceutical innovation at Hovione.
  • We provide bus transfer from the conference hotel to the Hovione sites. After the site visit there will be transfers to the airport and back to the conference hotel.
  • Due to competition reasons, individual participants may be excluded from the site visit
  • Participants are required to sign a Confidential Disclosure Agreement (CDA) before entering Hovione sites

Programme

Part I – Regulatory Considerations and Experience in Continuous Manufacturing
 
CDER Perspective on Advanced Manufacturing (Remote Presentation)
Dr Sau (Larry) Lee, FDA
  • The progress that FDA has made in CM will be discussed
  • The current expectations from FDA will be highlighted:
    • Submission review
    • Facility Evaluation
  • The recent trends and future challenges will be described

FDA’s Perspective on Continuous Manufacturing
Dr Rapti Madurawe, FDA
  • Development of ICH Q13 guidance and next steps
  • Key concepts of continuous manufacturing
  • FDA’s experience with CM and ongoing activities
  • Future directions
View from Innovators

Post Approval Change Management Plans (PACMPs) for Conversions to Continuous Manufacturing
Dr Bob Meyer, MSD
  • Application of ICH Q12 to continuous manufacturing
  • What makes a good candidate for conversion to continuous
  • Costs and benefits of PACMP
  • Case study 1 – legacy high-volume OSD product
  • Case study 2 – high-speed low volume OSD product
  • Takeaways and future directions
Advancements in the Application of Continuous Manufacturing at Eli Lilly
Dr Shashwat Gupta, Eli Lilly
  • Lilly’s history and experience with continuous direct compression
  • Lilly’s expansion of continuous manufacturing to wet granulation platform
  • Wet granulation control strategy
  • Summary and next steps for continuous manufacturing at Lilly
View from a Generic Manufacturer

Case Study TEVA: Continuous Manufacturing of direct Compression Tablets
Wayne Sinclair, TEVA
  • Implementation of CM in commercial manufacturing
  • Challenges and Benefits of CM in Generics manufacturing
  • Experience gained
  • Future outlook
View from CDMOs

Continuous Tableting (CT): Embracing Flexibility to Accelerate Manufacturing
Dr José Luís Santos, Hovione
  • The role of a CDMO for the adoption of emerging Technologies such as CT
  • Need for defining an equipment standard that enables maximum flexibility and Efficiency
  • Review of the modes of operation and control strategies that current CT equipment can support
  • Flexibility as an enabler of the acceleration of drug product manufacturing
  • Roadmap to simplification of CT: Hovione‘s journey
Transitioning to Continuous Manufacturing for OSD within a CDMO
Dr Doug Hausner, Thermofisher Scientific
The talk will provide an overview with case studies related to the challenges and successes in introducing continuous manufacturing for OSD including:
  • Comparing against batch internally and externally on batch size and Price
  • Technology selection both initial and ongoing
  • Adding technology and capabilities in partnership with clients, Real Time Release, High Potency
  • Expanding capabilities across a manufacturing network
Part II – Technology and Technology Providers

Process Understanding of combining Unit Operations for flexible Continuous Tableting (CT) Manufacturing
Dr Jim Holman, GEA
  • Overview of CT and flexible manufacturing lines
  • Study into the process robustness of the CT line over extended running
  • How data from CT lines can be better used for product understanding and process stability using soft sensors and data Analysis
  • Case studies showing adoption of CT and benefits on commercial products
The Possibilities of modular continuous wet Granulation Lines with regards to exchangeable Unit Operations
Dr Adrian Kape, Glatt
  • Introduction of the modular concept of a continuous wet granulation line
  • Process possibilities control Integration
  • Successful product development
Integrated PAT Data Management on Continuous Pharmaceutical Lines
Jan Verelst, Siemens
  • 21CFR11 compliant integration of (multiple) PAT Tools combined with an (existing) automation Environment
  • Structured data management of inputs from different data Sources
  • Real-time CQA Monitoring
  • Advanced Process Control
  • Some use cases
Part III – Latest Research & Development

Right First Time Manufacture of Pharmaceuticals
Prof Dr Jim Litster, University of Sheffield
  • Continuous manufacturing of oral solid dosage forms
  • Use of models across life cycle from model driven design to real time management and real time release
  • Integration across the whole flowsheet rather than a single unit Operation
  • Emphasis on appropriate use of machine learning (data driven) models
  • Validation on two different pilot plants in Sheffield and Purdue
Quality by Digital Design: Bridging Drug Substance and Drug Product Development
Prof Dr Alastair Florence, CMAC
  • Overview of our digital CMC vision and Quality be Digital Design Framework for medicines development and manufacturing
  • Predictive toolbox development for crystallisation (CCS) and drug product (MCS+)
  • Building the data fabric to support product and process development
  • Datafactories and automated workflows to accelerate development
Advancing the Design and Application of Digital Twins in Continuous Manufacturing Lines
Selma Celikovic, Research Center Pharmaceutical Engineering (RCPE)
  • Process modelling of continuous manufacturing lines
  • Design of digital twins in a simulation Environment
  • Control-oriented digital twin application on industrial Equipment
  • Digital transformation of the traditional manufacturing lines

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