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With increasing pressure to reduce overheads and enhance clinical effectiveness, QbD permits improvements and unnecessary expenses during development and manufacturing to be identified before production starts. The earlier these are implemented, the less expensive they become.

Through the strategic use of QbD and process analytical technology, we can save time, money and increase regulatory and business opportunities. Correctly employing a scientific, risk-based approach to lifecycle management, provides quantifiable benefits and value from:

  • Streamlined R&D and pre-market reviews
  • Improved quality with lower development risks
  • Faster product maturity
  • Fewer delays in manufacturing
  • Increased productivity
  • Lower overall costs
  • Easier regulatory compliance and flexibility 
  • Higher sale volumes

 

Together, these factors potentially provide $20-$30bn more in profit and speed time-to-market by years, conclude FDA and industry experts.

Achieving Quality by Design requires products and processes meeting predefined levels of quality, safety and efficacy.  Covering QbD as an end-to-end process for pharmaceuticals and biotherapeutics, attending this innovative, two-day conference will enable you to:

  • Refine and enhance a product's critical quality attributes
  • Develop a better manufacturing process design space
  • Employ QbD to design a formulation process
  • Harness raw material analysis and control strategy
  • Utilise PAT tools and applications for pharmaceuticals, biopharmaceuticals and ATMPs
  • Use risk assessment and management to best effect
  • Accurately include QbD information in regulatory document filings, including those for ICH Q8 and ASTM E 2500
  • Apply multivariate data analysis to maximise product development and patient outcomes 
  • Decrease development risks and overall costs
  • Improve product value, maturity and performance
  • Streamline R&D and pre-market reviews
  • Increase regulatory compliance and flexibility
  • Meet patient needs and maximise performance requirements

Chief Executive Officers, Chief Scientific Officers, Chief Technology Officers, Vice Presidents, Professors, Heads, Directors, Principal Scientists, Managers, Project/Team Leaders in:

  • Active Pharmaceutical Ingredients
  • Advanced Analytical Sciences/Analytical Development
  • Vaccine Development and Production
  • Antibody Development and Production
  • Advanced Therapy Medicinal Products
  • Materials Science
  • Chemical Engineering
  • Chemistry, Manufacturing and Control
  • Research and Development
  • Tabletting
  • Process Analytical Technology
  • Laboratory Information Management Systems
  • Product Lifecycle Management
  • Good Manufacturing Practice
  • Formulation Science
  • Stability Testing
  • Lyophilisation
  • Good Distribution Practice
  • Supply Chain

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Jesus Zurdo

Jesus Zurdo, Head of Innovation, Biopharma Development, Lonza Biologics

9:10 Implementing QbD in early development

David Lathbury

David Lathbury, Vice President of Chemical Development, AMRI

  • The foundation stone of QbD is process understanding
  • Many observations made in early development are neglected until later on in development
  • This represents a missed opportunity
  • 9:45 Drug substance design requirements

  • Biopharmaceutical and drug product manufacturing considerations when optimizing drug substance properties
  • Use of modelling tools and institutional knowledge to assist the process 
  • How to efficiently manage the QBD paradigm through the development cycle
  • Michael Leane

    Michael Leane, Principal Scientist, Materials Science, Bristol Myers Squibb

    10:20 Morning Coffee

    10:40 ICH Q11 - Development & Manufacture of Drug Substances - An Overview

    Keith McDonald

    Keith McDonald, Group Manager , MHRA

  • Describe the scope and purpose of ICH Q11
  • Overview of the content of the guideline
  • Regulatory context of Q11 with other EU guidelines
  • 11:15 Novel feedback control-based Quality by Design approaches for crystallisation processes using composite PAT-array and a crystallisation process informatics system

    Zoltan K Nagy

    Zoltan K Nagy, Professor of Chemical Engineering , Purdue University

  • Application of composite process analytical technology (PAT) array for monitoring crystallisation processes
  • Presentation of the Crystallisation Process Informatics System (CryPRINS) as an intelligent decision support and control system for crystallisation product design
  • Direct design and rapid scale-up of crystallisation processes using concentration feedback control and automated direct nucleation control (ADNC)
  • Application of ADNC for the control of size, shape, polymorphic form and purity of pharmaceutical products
  • Controlling crystal shape distribution using growth modifiers
  • Monitoring and control of continuous crystallisation systems
  • 11:50 Practical statistics for effective QbD in development from design of experiments to design space

    Bruno Boulanger

    Bruno Boulanger, CSO, Arlenda

  • Connecting the dots from the factory floor to the patient outcomes
  • Presenting statistical software solutions to achieve effectively QbD in development
  • Numerous examples on processes, analytical procedures and bioassays
  • Effective implementation of Q8 applied from small molecules to vaccines
  • 12:30 Networking Lunch

    13:30 Early risk mitigation approaches for selecting & designing better and safer biopharmaceuticals and avoid downstream complications

    Jesus Zurdo

    Jesus Zurdo, Head of Innovation, Biopharma Development, Lonza Biologics

  • Where ‘research’ meets ‘development’. Selecting and designing quality & functional attributes in lead candidates (pre-process QbD?)
  • Early assessment of developability & safety to reduce attrition and costs
  • In silico tools to predict and tune down developability & immunogenicity issues
  • Early (surrogate) parameters for risk assessment.  When the devil is not in the detail
  • 14:10 QbD for the development of antibody based bio-therapeutics

    Mariangela Spitali

    Mariangela Spitali, Associate Director, UCB

  • In the era of QbD, systematic and data-driven approaches to bio-therapeutics are needed more than ever
  • Such approaches are resource-intensive, costly and contradict the need for being lean and fast, particularly in early development
  • Is it possible to satisfy the “need for speed” in early development without compromising the systematic approach needed for building quality into processes and products?
  • 14:50 Afternoon Tea

    15:10 Implementation of DoE methodology for vaccine process development to better understand and efficiently process

    Nicolas Chaudet

    Nicolas Chaudet, Upstream Platform/Fermentation Unit , Sanofi Pasteur

  • Vaccine process : DoE,  an attractive tool to overcome the process development challenges from upstream to formulation and filling steps
  • DoE application : a perpetual compromise between methodology, information expected, scale down model, capacity and timelines
  • Case study : implementation of scale down model combined with DoE for process modelisation and improvement of vaccine manufacturing process at industrial scale
  • 15:50 The use of risk management to ensure the quality of viral vectors for clinical trial use

    Eleanor Berrie

    Eleanor Berrie, Qualified Person, University of Oxford Clinical BioManufacturing Facility

  • How do we ensure full traceability of starting materials for viral vectors?
  • What are the risks associated with the starting material for GMP manufacture of viral vectors?
  • How can the hazards be mitigated?
  • Possible issues due to the novelty of such IMPs and disease targets
  • Our experience to date
  • 16:30 PANEL DISCUSSION: QbD - where are we and what are the prospects for the future?

    Panellists will share strategies to move therapeutic entities from creation to development and commercialisation.  How can scientific evidence and molecular pharmacology best link with manufacturing process parameters and clinical activity relationships?  Improving real-time monitoring, specifications and product analysis for APIs,excipients, biologics and ATMPs to maximise patient benefit will all be considered.

    Jesus Zurdo

    Jesus Zurdo, Head of Innovation, Biopharma Development, Lonza Biologics

    David Lathbury

    David Lathbury, Vice President of Chemical Development, AMRI

    Zoltan K Nagy

    Zoltan K Nagy, Professor of Chemical Engineering , Purdue University

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Peter  Jones

    Peter Jones, Lead, Manufacturing Sciences and Technology, Oxford BioMedica

    9:10 New elastomeric formulation and the relevance of QBD in primary packaging

    Heike Kofler

    Heike Kofler, Manager Technical Customer Service Europe, West Pharmaceutical Services

  • Brief overview of Today´s Market Requirements for Primary Packaging Systems
  • New generation elastomeric materials for parenteral applications
  • The implementation of QbD principles in Primary Packaging
  • Benefits using QbD for Primary Packaging Systems
  • 9:50 Decisional tools for the design of robust and cost-effective bioprocesses

    Sofia Simaria

    Sofia Simaria, Lecturer, The Advanced Centre For Biochemical Engineering

  • Decisional tools work carried out in the EPSRC Centre for Innovative Manufacturing in emergent macromolecular therapies             
  • Tools enabling greater process understanding through modelling and optimisation and hence help achieve QbD
  • Demonstration of tools with case studies on the optimisation of purification sequence, equipment sizing and operating parameters of biopharmaceutical manufacturing processes
  • 10:30 Morning Coffee

    10:50 Using design of experiment in the lyophilisation of biological materials

    Paul Matejtschuk

    Paul Matejtschuk, Principal Scientist, National Institute For Biological Standards & Control

  • Lyophilization: the process benefits & challenges
  • Application of DoE in formulation development
  • Model studies of DoE in formulation development
  • Considerations for DoE in freeze drying cycle optimisation
  • 11:30 Using QbD & PAT to enhance process understanding

    Gary Montague

    Gary Montague, Head of School & Director, Research Centre in Biopharmaceutical & Bioprocessing Technology, Newcastle University

  • Managing the high dimensional data available from PAT
  • Maximising the information extracted from data
  • Risk-based decision making from available knowledge
  • Understanding the benefits of the approaches
  • 12:20 Networking Lunch

    13:30 Implementing product and process monitoring in biopharmaceutical manufacturing

    Dave Gervais

    Dave Gervais, Senior Process Scientist, Health Protection Agency

  • Understanding the link between process variables and product quality attributes
  • Demonstration of the effect of process changes on both in-process intermediates and final product quality
  • Utilising historical manufacturing data to establish acceptable ranges for process variables
  • Conducting process validation batches on legacy products, using in-process and final product monitoring
  • 14:10 Formulation problems for inhaled generics

    Simon Cooper

    Simon Cooper, Director, Process Development Technology & Scale-up, Mylan Pharma

  • Defining  the product profile
  • Understanding the design space?
  • Building a design space as applied to blending
  • 14:50 Afternoon Tea

    15:10 Process design to process qualification and beyond

    Ronan O'Kennedy

    Ronan O'Kennedy, Head of Cell Culture Process Development, Fujifilm Diosynth Biotechnologies

  • Using data in early-phase manufacturing for QbD
  • Benefits for a fuller QbD programme
  • Decreasing QbD timelines by effective use of early phase data
  • 15:50 Improving biotherapeutic recombinant protein yields from mammalian cell expression systems

    Mark Smales

    Mark Smales, Professor of Mammalian Biotechnology, University of Kent

  • Identifying limitations in mammalian cell expression systems
  • Novel approaches to the early selection and identification of high producing cell lines
  • Cell engineering approaches to enhance mammalian cell phenotypes
  • Translation engineering and reduced temperature cultivation
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    Peter  Jones

    Peter Jones, Lead, Manufacturing Sciences and Technology, Oxford BioMedica

    +

    FEATURED SPEAKERS

    Dave Gervais

    Dave Gervais

    Senior Process Scientist, Health Protection Agency
    Jesus Zurdo

    Jesus Zurdo

    Head of Innovation, Biopharma Development, Lonza Biologics
    Michael Leane

    Michael Leane

    Principal Scientist, Materials Science, Bristol Myers Squibb
    Ronan O'Kennedy

    Ronan O'Kennedy

    Head of Cell Culture Process Development, Fujifilm Diosynth Biotechnologies
    Simon Cooper

    Simon Cooper

    Director, Process Development Technology & Scale-up, Mylan Pharma
    Zoltan K Nagy

    Zoltan K Nagy

    Professor of Chemical Engineering , Purdue University

    Bruno Boulanger

    CSO, Arlenda
    Bruno Boulanger

    Dave Gervais

    Senior Process Scientist, Health Protection Agency
    Dave Gervais

    David Lathbury

    Vice President of Chemical Development, AMRI
    David Lathbury

    Eleanor Berrie

    Qualified Person, University of Oxford Clinical BioManufacturing Facility
    Eleanor Berrie

    Gary Montague

    Head of School & Director, Research Centre in Biopharmaceutical & Bioprocessing Technology, Newcastle University
    Gary Montague

    Heike Kofler

    Manager Technical Customer Service Europe, West Pharmaceutical Services
    Heike Kofler

    Jesus Zurdo

    Head of Innovation, Biopharma Development, Lonza Biologics
    Jesus Zurdo

    Keith McDonald

    Group Manager , MHRA
    Keith McDonald

    Mariangela Spitali

    Associate Director, UCB
    Mariangela Spitali

    Mark Smales

    Professor of Mammalian Biotechnology, University of Kent
    Mark Smales

    Michael Leane

    Principal Scientist, Materials Science, Bristol Myers Squibb
    Michael Leane

    Nicolas Chaudet

    Upstream Platform/Fermentation Unit , Sanofi Pasteur
    Nicolas Chaudet

    Paul Matejtschuk

    Principal Scientist, National Institute For Biological Standards & Control
    Paul Matejtschuk

    Peter Jones

    Lead, Manufacturing Sciences and Technology, Oxford BioMedica
    Peter  Jones

    Ronan O'Kennedy

    Head of Cell Culture Process Development, Fujifilm Diosynth Biotechnologies
    Ronan O'Kennedy

    Simon Cooper

    Director, Process Development Technology & Scale-up, Mylan Pharma
    Simon Cooper

    Sofia Simaria

    Lecturer, The Advanced Centre For Biochemical Engineering
    Sofia Simaria

    Zoltan K Nagy

    Professor of Chemical Engineering , Purdue University
    Zoltan K Nagy

    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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