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Keynote Speeches

New EMA Drafts: GMP Guideline Chapters 3 and 5 Guideline on Setting Health-Based Exposure Limits

This presentation will present evolution of chapters 3 and 5 of EU GMP’s. This will cover incorporation of toxicological guidance to define which process or products will require dedicated facilities or equipment trains and which will comply with shared multiproduct facilities.

The presentation will introduce the “guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”.

The presentation will cover as well comments from industry sent to EMA for all the documents which are under consultation process chapters 3 & 5 and Tox. tool


Dr. Andreas Flückiger, Chief Occupational Health Officer, F. Hoffmann-La Roche Ltd

Track 1: Operations

Cleaning Standards in Multi-Product Facilities

This presentation addresses the new challenges that the industry is facing to prepare risk assessments for multi-product use of facilities that will be acceptable to the medicinal authorities.

After decades of conservative but unscientific cleaning standards for multi-product facilities, a paradigm shift is occurring. The FDA and EMA are asking for more scientific, in particular more toxicologically sound input into the risk assessments for multi-product use of facilities. After an introduction explaining the regulatory background, this presentation will show solutions for meeting these new challenges. It will explain the principles for setting the required limit values (PDEs/ADEs) and process adaptations necessary in a QA organisation in order to communicate with the scientific community that provides these limit values. The synergies between worker safety and product safety efforts will be pointed out.

Delegates will gain:

  • Knowledge of the new regulatory drivers regarding multi-product use of facilities
  • Solutions for acquiring and applying the toxicological input that is now required, illustrated by examples
  • Insight into synergies between containment solutions installed for worker protection and their benefit for control of cross contamination


Dr. Andreas Flückiger, Chief Occupational Health Officer, F. Hoffmann-La Roche Ltd

Continuous Flow Reactors: An Opportunity for the Development of Flexible and Sustainable Production Processes

This session will explore how the pharmaceutical industry can benefit from the advantages that flow chemistry can bring to production processes. 

The past decade has seen the modern synthetic chemist embrace the use of continuous flow reactor technology as a tool for reaction control and process optimisation, with technology making the successful transfer from academia to industry. For the first time this means that medicinal, development and process chemists within the pharmaceutical industry are able to utilise similar technology to synthesise new chemical entities and their subsequent large-scale production. This impacts not only the speed with which compounds are identified and transferred to production, but also the efficiency with which they can be produced and the ease with which production volume can be ramped up or down to meet changing market demands.

Delegates will gain:

  • Understanding of how to access novel process windows in the laboratory and plant with increased safety
  • Faster product development via rapid process optimisation and facile up-scaling
  • Shorter development cycles and a reduction in plant size
  • New methods and materials for chemical research and production
  • Opportunities for both time and financial savings through harnessing the advantages of flow processing
  • New reactor material for production scale flow processing, EKasic® silicon carbide - excellent corrosion resistance and five times higher thermal conductivity than stainless steel
  • Insight into the flexibility associated with a flow production plant


Dr. Charlotte Wiles, Chief Technology Officer, Chemtrix BV, UK

Filling Systems for the Future

Final filling of biotechnology drugs is much more complex than filling of chemical drugs. Proteins are more sensitive. Cleaning and cleaning validation are a challenge for pharmaceutical companies as well as for the suppliers of filling systems. Nevertheless, the requirements for conventional filling are still valid: maintaining sterility, increasing accuracy, high yield, no dripping of the filling needles, no splashing in the primary container (syringe, vial, cartridge), no particles and so on.

The choice and setup of the right filling system are crucial. There is no clear black and white decision: piston pumps have proved reliable over decades and guarantee high output and outstanding accuracy. But they apply a high shear force to the drug compared with other filling methods. Peristaltic pumps are not as accurate and cannot guarantee the highest output. But they are much more careful to the biotech drug as the piston pump. They also allow to set up a complete single use filling set.

For biotechnology drugs it is often hard or even impossible to get a cleaning/cleaning validation of a conventional stainless steel filling system. An alternative is a single use filling system. This session will present a solution of a ready-to-use single use filling system that has been pre-validated. Validation includes: filling performance, particulates, sterilisation, endotoxins, extractables and shipment.

The session will cover:

  • Market requirements
  • Available filling systems for fill/finish and how to choose the right system
  • Combination filling systems for a higher flexibility
  • A fully single use filling system
  • Validation approach for a single use filling system
  • Pro's and con's plastic vs. stainless steel


Klaus Ullherr, Packaging Technology, Product Manager, Robert Bosch GmbH

Buffer and Media Preparation for New and Expanding Facilities

Single-use technologies for buffer and media preparation have enabled the expansion of existing facilities at significantly lower capital costs relative to traditional stainless-steel systems. Reductions in commissioning activities, facility shutdown, and cleaning validation requirements can further decrease implementation timelines and costs. However, significant technical and economic issues must be dealt with in order to ensure proper technology selection. In this study, a cost comparison of single-use and stainless steel equipment for buffer and media preparation demonstrated the economic benefits and limitations of SU mixers over a range of process scales and facility run rates. Furthermore, a novel methodology was developed to assess the feasibility and predict the solution mix times for buffer salt and cell culture media mixtures in a single-use mixer family at volumes ranging from 10 to 1000 L. Verifying SU mixer performance at a reduced scale lowers resource consumption and decreases the cost of process characterization. Combining this cost and process modeling approach enables the proper selection of technology and equipment for streamlined and efficient expansion of buffer and media preparation facilities.


Adam Sokolnicki, Biomanufacturing Engineer, EMD Millipore

ConsiGma™, the Continuous Manufacturing Platform for Flexible Pharmaceutical Solid Dosage Production

In this presentation, the ConsiGma™ continuous manufacturing platform will be discussed.

The system satisfies the pharmaceutical industry’s demand for continuous production to provide improved quality, flexibility, agility, consistency and cost reduction for pharmaceutical processes.

Topics that will be addressed are a.o. the position of regulatory agencies towards continuous processing, real-time release strategies in continuous processing and how ConsiGma™ can enhance ‘green’ production compared to batch manufacturing.


Kris Schoeters, Product Manager Continuous Processing, GEA

What are the Challenges of Operating Flexible and Shared Production Plant?

This presentation will provide an overview of the challenges of operating flexible and shared production facilities. Chris Mullen will share lessons learned from his 10 years's experience of operating such a facility. 

Delegates will gain:

  • An operations managers view of the challenges of operating a flexible and shared facility 
  • Implemented solutions to these challenges 
  • The impact on the staff operating the facilities 
  • A view of the future challenges, and their potential solutions, to operating these facilities


Chris Mullen, Head of Operations, Fujifilm Diosynth Biotechnologies

Review of R.A.B.S. and Isolators and Assessment of Benefits and Risks

This presentation will focus on key aspects of design in relation to ergonomics, visibility, machine isolator integration and cleanability.

This presentation will draw attention to the need for improved understanding and decision-making relating to which containment system is most appropriate for use. Delegates will identify key issues relating to the operation of these containment systems.

Delegates will gain:

  • Understanding of risks and benefits for design and use of R.A.B.S. and isolators
  • Analysis of operational risks and how they may be addressed


Niall O'Meara, Director of Manufacturing, Amgen

Manufacture of Biological Investigational Medicinal Products in Multi-Product Facilities. Potency Toxicity and Banding

There is increasing requirement to consider and use health-based limits and similar approaches when manufacturing products in multi-product facilities, EMA update December 2009 and RiskMaPP 2010. In 2011 we implemented an approach for late stage product manufacture in our facilities which is based on the use of Acceptable Daily Exposure (ADE) and MACO calculations when considering product to product transitions. Under these circumstances there will in all probability be considerable knowledge of the potency of the molecules, of their intended dosages and of the sequence of manufacture. A risk-based approach using ADE and MACO calculations is viewed as an appropriate way to consider risk. However there are a number of fundamental problems that make such an approach difficult to use when considering manufactures of investigational medicinal products (IMPs)( particularly material being manufactured for intended preclinical and phase1 trails) in a clinical product facility.

These are:

  • For IMPs there may be no or little toxicological information allowing calculation of an ADE
  • Decisions to manufacture IMPs are often made before information relating to the identity of subsequent products in the manufacturing assets is available
  • For IMPs the intended dosage of product and subsequent product may not be known at the point of manufacture thus preventing meaningful MACO calculations
  • Highly sensitive product specific assays are frequently not available until late clinical phase

In light of these issues Fujifilm Diosynth Biotechnologies UK has presented a proposal for an approach that enables a risk-based framework for assessment of the manufacture of biotechnology IMPs in a multi-product facility that uses health-based considerations.  This approach is based on a classification or banding of potential products into categories reflecting their actual or probable ADE.

The objective is to present an alternative approach which could be used in a risk-based framework for multi-product  manufacture of biotechnology products using health-based cleaning limits in clinical product manufacturing facilities when considering product entry and product to product transitions. It specifically applies to manufactures being considered for early phase IMP’s where no or very little toxicological data is available on which to derive an ADE limit.


Colin Gall, Manufacturing Support Manager, Fujifilm Diosynth Biotechnologies

Track 2: Facilities and Plants

Disposable-Stainless Steel Hybrid Facilities: Challenges, Risks and Gains for Bioprocess Development and Production

This session will present how Boehringer Ingelheim applies the new, flexible and still maturing disposable technology in combination with common stainless steel applications to the needs in development and production for biotechnology processes. The session will also include case studies on pitfalls and lessons learned when applying disposables.

Topics will include:

  • Challenges and gains in flexibility and time to market applying a fully disposable and/or hybrid and/or stainless steel approach
  • Maturing a new technology (disposables) to successfully apply it for development and production of biotechnology products

Delegates will learn about risks and solutions from disposable biotechnology applications from development to production.


Dr. Joachim Baer, Associate Director of Upstream Manufacturing Sciences, Boehringer Ingelheim GmbH Biopharmaceutical Operations

Transforming the Sourcing Biologics

Biotechnology unit productivity has increased significantly in the last ten years. High titers are now common and lead to large facilities being underutilized and costly to retrofit. Wide-spread adoption of single use technology to produce biotherapeutics and continued pressure to reduce capital expenditures and risk have had a significant impact on facility design and the delivery method for new facilities. Many of these approaches are modular in nature but DoveTail Integrated Systems has created a highly adaptable, cost effective platform delivering facilities suitable for a wide range of bio-pharmaceutical production processes. This presentation will illustrate how these pressures and technology advances enable flexible design and production capacity along with new facility construction approaches that reduce delivery time, capital expended and risk. The presentation will also cover case study comparability data between traditional facility delivery approaches and the Dovetail methodology.


Bart van Praag, Director, Dove Tail Integrated Systems

New Strategies for Aseptic Filling for Emerging Markets

This session will explore how to improve flexibility of supply of injectable drugs by developing local manufacturing sites.

Topics will include:

  • The combination of modular building with the Closed Vial Technology allows to define a new strategy based on “Global bulk – local fill”
  • Bulk would be produced in a limited amount of major production sites and shipped to multiple local filling sites
  • Key advantages are: flexible supply chain, limited transportation costs (low volume, low weight), reduced risk on supply chain thanks to smaller batch size
  • Such strategy is achievable thanks to the benefit of the Closed Vial Technology (ready-to-fill containers, limited use of utilities, CVFS barrier in ISO8 clean room, etc)

Delegates will learn that:

  • A new strategy is possible to supply emerging markets with aseptic injectable drugs
  • The combination of simplified technologies using ready-to-fill technologies and modular buildings makes that strategy achievable


Jan Lilja, Director Commercial Management, KeyPlants

Benoît Verjans, Scientific Advisor, Aseptic Technologies

What Challenges Regulatory Requirements Set from a Plant and Facility Design Perspective? Impact of New Chapters 3-5 and Toolkit for Toxicology

This presentation will review the changes to the cGMPs and the impact of applying risk assessment in the design process. Experience with a subjective risk assessment methodology used in AZ to assess cross contamination in OSD and other facilities will be shared. Strengths and weaknesses of such methodology will also be presented as well as similar approaches.

The application of risk based methodologies creates the opportunity to apply scientific principles to the risk of product adulteration during the pharmaceutical manufacturing process. A number of methodologies have been proposed but it has been difficult in some cases to provide quantification methods to validate the outcomes. As a result, subjective assessment methods are commonly applied by individual companies and no standardised approach has yet been developed.


Peter J. Marshall, Principal Technology Engineer, AstraZeneca

Economic Risk Minimisation of Single Use Cell Culture - Scale Up vs. Scale Out

The talk will review optimal strategies for using disposables cell culture systems in hybrid facilities (a mixture of stainless and disposable technologies). In particular we will examine the costs of these facilities, their scalability and where they have advantages over a conventional reference stainless steel facility and where they do not. The questions that are addressed are:

  • What is the best configuration for the hybrid facility? Multiple 1000L bioreactors or multiple 2000L bioreactors?
  • What harvest configuration should be used in terms of pooling bioreactor harvests?
  • How does the best hybrid option compare to stainless steel with changing facility utilisation?
  • What is the best option where there is uncertainty regard the product sales?


Miriam Monge, Vice President Sales & Marketing, Biopharm Services Ltd

Modular Plant Design - Cheaper and More Efficient?

Recently, a number of different trends have converged to demand a new type of biopharmaceutical manufacturing facilities, one that emphasizes flexibility and agility. Drawing this new blueprint is:

  • Business needs to minimize timelines and financial risks
  • "Biotech on demand,” and the ability to shore up local manufacturing capacity, quickly, to meet market needs
  • National security needs for systems that can easily and rapidly respond to biological attacks
  • Urgent national health needs to protect the public from large-scale, fast moving epidemics and pandemics

Today’s biopharmaceutical manufacturing facilities are smaller, more flexible, efficient and cost-effective than those of the 1990’s, and they are able to adapt quickly to market changes. The goal isn’t technology in and of itself but greater product and process knowhow for speed to market. With modular systems, we could now place an entire small-scale clinical production line inside a manufacturing suite/environment that could be easily scaled up or redeployed elsewhere as needed. We would supplement the technology with case studies that are in operation today as a proof of concept and technology robustness and the progress made in this area of patient health needs delivery and support systems.

The presentation does include many facets of a project lifecycles including:

  • Why this concept is suitable for small scale as well as large volumes products
  • Speculation on capital and operational costs
  • Environmental background of surrounding space
  • Schedules…start to finish of such projects
  • Regulatory assessment and type C meeting associated with the case study
  • Advantages, disadvantages, risks mitigations and limitations of the concept
  • Type of product and batch sizes this flexible concept is suitable for


Robert Dream, Principal, HDR COMPANY LLC

How to Increase the Flexibility by Standardisation for Vaccine Facility Design (Case Study)

By combining standardisation by ‘item’ design, it’s possible to increase the flexibility in your Vaccine facility.

This presentation will – based on a number of Vaccine facility cases – show how it is possible to increase the flexibility in a Vaccine facility by using the optimal design tools in combination of standardization. Design principles for a Multi-product BSL2+ facility will be shown as well as a number of flexible designs for more ‘dedicated’ facilities. The impact of SU technology on the Vaccine facility design will be covered as well.

The presentation will also cover some of the regulatory challenges that are related to the design of multi-product facilities, including the risks and limitations.


Klaus Hermansen, Senior Technology Partner, Vaccines, NNE Pharmaplan

Sustainability and Ecologic Considerations: How to Comply with Environmental Regulation While Designing a Flexible Facility? (GMP Perspective?)

Production of pharmaceuticals may result in discharge of Active Pharmaceutical Ingredients (API) and other chemicals into the environment. Occurrence of API in drinking water and in the aquatic environment has been widely documented. Growing body of evidence from eco-toxicological studies in laboratory and in field clearly indicates that concentrations of APIs in the aquatic environment may already now cause adverse effects in exposed populations. Occurrence of API in drinking water and in the aquatic environment raises concerns and implies the need for regulatory measures aiming at reducing/elimination of APIs in the environment. One of these measures is to limit emissions of the substances from production sites. This can be done by including specific requirements in current environmental legislation and/or in the medicine legislation, i.e. GMP. The presentation will discuss both options.

Delegates will gain:

  • Understanding of the reasons behind future possible regulatory measures aimed at reducing emission of APIs into the environment 
  • Understanding the need for inclusion of measures reducing the emissions in already existing and in planned new production facilities


Kia Salin, Environmental Strategist, Swedish Medical Products Agency

Track 3: IT and Automation

Implementation of Quality by Design using MES

This session will explore opportunities to apply MES (Manufacturing Execution System) capabilities in advancing Quality by Design (QbD) from R&D into Manufacturing. The concepts of both MES and QbD and the benefits of integrating MES capabilities into the QbD framework will be presented. Manufacturing and process knowledge becomes a tool for design change and improvement in studying the influence of the automated manufacturing environment on acceptable CQAs and CPPs.

This presentation will look into product knowledge as a component of knowledge management, which originates in R&D and needs to be adjusted in the manufacturing phase while maintaining compliance. Delegates will gain insight provided by MES professionals who identify, analyse, and propose solutions to specific manufacturing problems faced by life science companies.


Philip Rees, Senior Manager, Aston Life Sciences

Paperless Lab to support Quality by Design (QbD) initiatives

QbD will be the norm within 10 years and manufacturing efficiency will be significantly improved. Adoption of an integrated Product Quality Lifecycle Process facilitates innovation, continual improvement and strengthens the link between pharmaceutical development and manufacturing activities.

The power of a Paperless Laboratory is the ability to enable organizations to implement self-documenting processes that produces both non and GxP-compliant documentation which eliminates unnecessary tasks from the workflow, to result in a significant cost of non-compliance to support corporate Cost of Goods Sold (COGS) optimization.

This presentation will highlight how QbD and Paperless Lab processes enables organizations to create start-to-finish knowledge management repository to adopt cross functional collaboration between management, scientists and engineers responsible for products in development and manufacturing, processes, equipment and facilities.


Peter Boogaard, Founder, Industrial Lab Automation

Facilitating Flexible Manufacturing through IT Data Standards

This presentation looks at how integrated IT systems and the use of standard data models such as S88 and S95 can facilitate increased flexibility in forecasting, production planning, production scheduling and manufacturing while still assuring product quality. This requires the integration of systems ranging from Enterprise Resource Planning (ERP) systems (including planning and scheduling), Manufacturing Execution Systems (MES) and process and equipment control systems.

While other industries have adopted applicable IT standards to allow the flexible and efficient interchange of recipes, bills of material, production specifications and schedules, the pharmaceutical industry has been somewhat slow to adopt such standards, driven in part by a desire to retain process repeatability in support of product quality.

The increasing use of Quality by Design (QbD) and a focus on product quality critical attributes and quality critical controls allows a more flexible use of production facilities while still recognizing the need to assure product quality.

This presentation shows how such requirements can be supported by the use of existing data standards and existing technology, allowing pharmaceutical companies to achieve the flexible use of facilities without compromising product quality.


David Stokes, Consultant, Precipient

Benefits and Challenges when Moving from a Batch Process to Continuous 

Small footprint, multi-product flexible plants is what the Pharma Industry needs to meet with the challenges of today. Continuous processing fist to these requirements but it imposes challenges to the industry. How to define a batch in a continuous process for product release, how to guarantee material tracking within the complete production chain. Smaller footprints but more integrated plants with a higher level of automation and IT pose challenges to OEM and end-user. Plant engineering tools allow for fast track, object oriented engineering with distributed teams based at different locations. 3-D Simulation tools shorten the front end design study and are basis for early business case evaluations and FMEA studies. Documentation developed during engineering transferred into operations facilitate to keep the plant in a validated state.


Ivo Backx, Business Development Solutions for Life Sciences Industries, Siemens

Establishing Automation Strategies for Flexible Facilities

Traditional approaches to pharmaceutical manufacturing have thrived on fairly rigid facilities and avoided changes to automation at all costs. A future demanding flexibility and agility requires a different perspective – automation approaches that embrace change, work with the facility and operators whilst delivering consistency and control. This presentation will outline both the challenges and potential approaches that can be adopted to avoid designing for the now, rather than the future.


Dr. Peter Iles-Smith, Manufacturing IT Technical DIrector - Global Manufacturing & Supply IT, GSK

The Impact of Evolving Serialisation Requirements on the Broader Pharmaceutical Industry

This presentation will address the evolving requirement to track pharmaceutical products at unit of sale level, how this impacts on packaging and supply chain, cost and difficulties of implementation, how serialisation fits with other trends in pharma and the benefits of serialisation beyond the immediate target of reduction of counterfeit medicines.


Liam O’Riordan, Serialisation Director, ESP Ireland

Maintaining Compliance with a Flexible Operation

This presentation considers technology and techniques which are proven in the industry to deliver a flexible automation system in a multi-product facility. Such a system includes mobile equipment which connects to the system and is used in different locations and for variable purposes. The system is of course under configuration management with flexibility such that all products can be produced without change to that configuration. Where a new product is added to the capability of a facility this is done with minimum impact to the system and using existing configuration elements. This improves both business agility and productivity of the facility.

The design of a facility which has sufficient flexibility to produce multiple products has automation challenges. The automation system must be compliant while still accommodating flexible equipment configurations to produce multiple products without any change to the system. When a new product is brought to an existing facility, the impact of any changes must be minimised.

Through this presentation delegates will learn about technologies and techniques already deployed in the industry to economically achieve automation flexibility.


Chris Morse, Product Manager, Honeywell Process Solutions

Demonstrator Workshops

Ready to Use Aseptic Fill & Finish for Small Batch

Disposable-lab did design the first “ready to use Aseptic fill & finish” for small batches (up to 1000 vials or syringes).

The set include a single use Isolator which is pre fill with vials, stopper and capping required by the client. At reception the Isolator is filled with sterile air or Nitrogen and the filling can start. Filling, stopper and capping are done manually. At the end, the set of fill Vials is exiting and the isolator is collapsed and go to destruction.

This technology avoid any cleaning or cleaning validation. The vials are sterile and depyrogened “Pyrofree®” by high temperature in there packaging under vacuum. The set of stopper and capping is pre sterilized as well. All the material required for the batch is introduced in the Isolator with our Flushing Isolator. There is no investment and each set is adapted to the customer requirement. The filling is done in a close sterile and clean Isolator which reaches Class A specifications.


Dr Jean Pascal Zambaux, President, Disposable-Lab SAS

Flexible Containment Technologies – Handling of Toxic and Highly Hazardous Substances in API- and Pharmaceutical Industries

The handling of toxic and highly hazardous substances in API/pharmaceutical production is constantly increasing. Therefore the requirements for the manufacturers are also rising. On the other hand you have to look at the economic requirements such as cost reduction. The introduction of “Flexible Containment Technologies“ demonstrates you the advantages in comparison with conventional technologies.


Richard Denk, Director of Pharma Department, Hecht Technologie GmbH

Dry Granulation: a Key Element in (Continuous) Manufacturing

We will develop our presentation to emphasise and elaborate on the main aspects relating to manufacturing flexibility, scale up efficiency, and how the use of this technology can significantly impact facility requirements and operational costs.

During the presentation and live streaming we will explain the market conditions and requirements for flexible batch and continuous manufacturing, how and what dry granulation of this type can achieve in this field, technically how it achieves such control and process advantages, and how robust the process supported by live demonstrations via live link to the Gerteis laboratory. Then we will substantiate the scale up and the future impact on facilities and sustainability.

A live stream presentation of relevant parameters for controlling product quality during dry granulation, whilst dealing with the following topics:

  • Universal granulation process with largest scale up factor
    - not only for heat and temperature sensitive formulations
  • Suitable for a large range of API concentrations and powder bulk densities,
    - both for instant and sustained release formulations, also of poorly wettable drugs
  • Constant product quality both within a batch and from batch to batch,
    - realized by perfect control of all parameters relevant to product quality and
    - embedded PAT features
  • Throughput can be easily adapted to the speed of a tablet press/packaging line in a continuous manufacturing system
    - without any influence on granule quality, since
    - scale up is completely known
  • Development with very low amounts of powder (gram scale) without scale up problems,
    - enabling the evaluation of dry granulation in a very early stage of development
    - whilst specific requirements to dry granulation excipients are largely known
  • Economically most attractive granulation method
    - small footprint
    - low energy
  • Granulation method of choice for High Containment applications
    - from standard: 3µg/m³ till < 0.1 µg/m³
    - fully CIP-able


Stephen Boswell, Director, S3 Process Limited

Rob Lammens, Consultant, Bonn University

Hartmut Vom Bay, Vice President, Gerteis

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