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SAE Media Group are proud to announce the 3rd annual Aseptic Processing UK conference, returning on18-19 September 2023.

Grab your ticket today!

What’s different this year:

This year’s conference sees double the number of pharmaceutical speakers providing first-hand examples of how they have implemented aseptic processes. As well as delving into more focus on the ever-growing rise of advanced therapies from allogenic cell therapies to innovative fill-finish lines, more than ever before SAE’s Aseptic Processing Conference encompasses the full drug product journey from the first step to the final post-sterilisation testing.
 

This is the only event that will:


The only event that will give you the chance to hear real world evidence from leading pharmaceutical companies across the UK, EU and USA on their aseptic processing journey, bringing all levels of the manufacturing journey and cutting-edge solution providers to discuss the challenges and opportunities for a more efficient aseptic programme.

 

  • DELVE into the role that aseptic process plays in the development of advanced therapeutics pipelines with examples from the world of allogenic cell therapies, lentiviral gene therapies and sterile medicinal products
  • REVIEW case studies on the implementation of modern microbial testing methods, advanced sterilisation techniques and innovative isolator technology from Bayer, AstraZeneca and MSD
  • LEARN how to control water contamination and execute a quality by design approach to pharmaceutical manufacturing facility to ensure reliable testing
  • BENCHMARK against case studies of harmonised and holistic aseptic processing strategies driving pharmaceutical manufacturing frameworks towards a fully globalised structure
  • INCREASE your understanding of regulatory body expectations on current attitudes to aseptic processing and the approaches you can take to guarantee your compliance

 

The Aseptic Processing conference will be providing pharmaceutical manufacturing professionals insight to poduct quality and patient safety assurance. 
 
Professionals such as: 
  • Heads of Quality Control
  • Head of Aseptic Processing
  • Director, Qualtiy Control- Microbiology/Manufacturing
  • Head of GMP Compliance
  • Head of Sterility Assurance
  • Contamination Control Lead

& many others! 

 

Industry: 

  • Pharmaceutical Manufacturing



 

 


 

Conference programme

8:00 Registration & Coffee

9:00 Chairman's Opening Remarks

James Drinkwater

James Drinkwater, Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
View Bio

9:10 Navigating the latest GMP Guidelines and Regulatory Landscape- Overcoming Common Challenges and misunderstandings

James Drinkwater

James Drinkwater, Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
View Bio

  • Benchmarking the effects of Annex I, regulations and guidance changes and pinpointing key challenges
  • Understanding the objectives and outcomes of Annex 1 and discussing it’s success
  • Improving constantly- How to stay ahead of regulatory changes in the future
  • 9:50 Improving Pre-Use Post Sterilisation Integrity Testing (PUPSIT) within new

    Chris Hutchins

    Chris Hutchins, Senior Manager QC Microbiology, GSK
    View Bio

  • Understanding the regulatory environment around PUPSIT
  • Implementing a single-use approach to design
  • Holistic risk assessment approaches for equipment design
  • Dry leak testing, flushing dynamics, Integrity test selection and dilution/ drying challenges
  • 10:30 Morning Coffee

    11:00 Transfer and Scale-up of Biologics Aseptic Manufacturing Processes through Control Site Concept

    Thais Vilgren

    Thais Vilgren, Project Manager, Novo Nordisk

  •  Innovative Aseptic Manufacturing (vials, syringes, cartridges) and definition of “Agile Manufacturing”
  • Novel environmental monitoring by biofluorescence
  • Gloveless fully automated & autonomous equipment
  • 12:20 Networking Lunch

    13:20 Moving forward on aseptic filling with continuous and real-time environmental monitoring

    Petra Merker

    Petra Merker, Manager - Biological Quality Control, Bayer
    View Bio

  •  Optimising finish and fill in aseptic facilities with improved technology implementation
  •  Implementing visual inspection in aseptic manufacturing and filling
  •  Critical analysis of technological improvements for aseptic filling
  •  Understanding the GMP requirements for aseptic fill
  • 14:00 Implementation and validation of innovative sterilization and bio decontamination technologies

    Dan Kynaston

    Dan Kynaston, Sterilization Capability Owner, AstraZeneca

  •  Opportunities for the implementation of innovative sterilisation techniques in bioprocessing
  • Understanding the benefits and drawbacks of different methods of sterilisation
  • Overcoming regulatory challenges with alternative sterilisation techniques
  • 14:40 Afternoon Tea

    15:10 Environmental Monitoring in Modern Biopharmaceutical DP Facilities- A Proposal for a Harmonized Risk Based Approach for Selecting

    15:50 Cleanroom disinfectant and development as part of CCS validation

    Florian Grundmann

    Florian Grundmann, Team Lead Cleaning Validation, MSAT, F. Hoffmann-La Roche Ltd.

  •  Minimising danger and maximising planning ISO 14644-3 
  • Regulatory and GMP expectations.
  • Strengthening your CCS with a proven recovery plan
  •  Case studies for worst-case scenario recovery
  • 16:30 Chairman’s Closing Remarks and Close of Day One

    8:00 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 Contamination Control Considerations for Cell and Gene Therapies

    9:50 Challenges for New Technologies in Sterile Medicinal Products- Outlined in Revised Annex 1 Regulations

    Christian Zeine

    Christian Zeine, Scientific Affairs Manager, US Pharmacopeia

  • Defining Aseptic Processing from an MHRA point of view 
  • Maximising synchronisation with European, US and other regulators 
  • Eliminating the misunderstandings around the most challenging Annex 1 changes
  •  Sterile vs non-sterile manufacturing and how the MHRA is differentiating the two
  • 10:30 Morning Coffee

    11:00 Best practices and innovation for environmental monitoring

    Jan-Jaap Schot

    Jan-Jaap Schot, Associate Director- Site Microbiology Lead, MSD

  •   Optimal translation of QRA into an EM sampling plan
  •  Maximising data integrity with paperless and automated sampling workflows
  •  Innovation using real time detection techniques
  •  Automation on incubation and plate result
  • 11:40 Enhancing Contamination Control in Allogenic Cell Therapy facilities

    Tishwant Kanwarjit

    Tishwant Kanwarjit, Director of QA & QP , Autolus Ltd
    View Bio

  • Approaches taken for a multi-site collaborator facility
  • Steps taken when considering the contamination control strategy
  • Potential challenges of the CCS and assessing how to overcome these
  • Summary of the overall project and guidance on presenting to the auditor
  • 12:20 Networking Lunch

    13:20 Minimizing contamination risk throughout the manufacturing process with improved isolator technology

    Marco Cuomo

    Marco Cuomo, Manager Applied Technology Innovation, Novartis

  • Increasing demands for higher isolator system quality throughout aseptic manufacturing
  • Understanding the risk factors and the implementation of risk mitigation factors: from leak detection and integrity to glove holes
  • Global regulatory expectations and updates for technical compliance
  • Examples of successful implementations of improved isolator technology
  • 14:00 Enhancing Finish-Fill for ATMPS: Lentiviral Vectors

    Leslie Southam

    Leslie Southam, Director- Quality Assurance, Oxford BioMedica
    View Bio

    • Overview of the combined finish-fill project at Oxford Biomedica
    • Approaches to risk assessment for finish and fill facilities
    • Potential challenges of the CCS and assessing how to overcome these
    • Summary of the overall project and guidance on presenting to the auditor

    14:40 Afternoon Tea

    15:10 How Updates to EU GMP Annex 1 Impact Sterilizing Filtration in Single Use

    Mary Doody

    Mary Doody, Associate Director of Quality, MSD

  • Receive a summary of key updates to EU GMP Annex 1
  • Learn how your filtration systems can help meet the requirements of Annex 1
  • Learn how comprehensive supplier testing information accelerates implementation of single use systems
  • 15:50 Implementation of a risk-based approach to use pre-use post-sterilization

    Marc Steffens

    Marc Steffens, Global Project Manager , Roche

  • Risk assessment for PUPSIT and considerations of associated risks in established processes
  • PUPSIT risk assessment: The Impact of Equipment Design
  • Moving beyond Annex 1’s controversial approach to PUPSIT
  • Harmonising across multiple pharmaceutical networks to establish consistent and easy-to understand guidelines
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    Senior Manager QC Microbiology
    GSK
    Head of Unit Environmental Monitoring
    Boehringer Ingelheim
    Scientific Affairs Manager
    US Pharmacopeia
    Sterilization Capability Owner
    AstraZeneca
    Team Lead Cleaning Validation, MSAT
    F. Hoffmann-La Roche Ltd.
    Head of GMP compliance and Aseptic Processing support
    Franz Ziel GmbH
    Associate Director- Site Microbiology Lead
    MSD
    Director- Quality Assurance
    Oxford BioMedica
    Manager Qualification / Validation, Aseptic Quality Assurance
    Boehringer Ingelheim Pharma GmbH & Co. KG
    Global Project Manager
    Roche
    Manager Applied Technology Innovation
    Novartis
    Associate Director of Quality
    MSD
    Manager - Biological Quality Control
    Bayer
    Project Manager
    Novo Nordisk
    Director of QA & QP
    Autolus Ltd

    Exhibitors

    VENUE

    Hilton London Kensington

    179-199 Holland Park Avenue, London, United Kingdom

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Exhibitors


    Cherwell

    Exhibitors
    http://www.cherwell-labs.co.uk.

    Cherwell Laboratories Ltd is a UK manufacturer and supplier of the prepared media Redipor®. The Head Office is in Bicester, Oxfordshire and can boast an excellent transport network, which enables its abilities to work effectively with the Export and Distribution partners as well as all Domestic customers.

    With over 50 years’ experience, Cherwell has become a specialist supplier of ‘cleanroom microbiology solutions’ with products for environmental monitoring and process validation for healthcare, pharmaceutical and industrial applications.

    Because environmental monitoring is a critical element to any manufacturing process, Cherwell focuses on supplying high quality, reliable products, that are supported by expert knowledge. The range within the product portfolio enables professionals to make informed decisions about their cleanroom environment, and sterility processes. Which allows them to select the best suited solutions for them to manage risk associated with a robust contamination control strategy.

    The SAS air environmental sampling range is reliable and robust equipment known to conform to the Annex 1 requirement of 1m³.

    The new ImpactAIR is designed for high-risk graded environments, deploying a monitoring innovation that is called ‘slit to agar’. This system uses a Redipor 9cm plate rather than the standard 14cm. The process provides assurances on potential contamination within the cleanroom environment with a D50 value of 0.53 micron capturing the extremely small-scale particles, complying with the Annex 1 requirements

    We work in partnership within the market and take pride in sharing our knowledge, experience and expertise to ensure that everyone is using our portfolio in the best way possible for their environmental needs and expectations.



    Microgenetics

    Exhibitors
    https://www.microgenetics.co.uk/

    Environmental monitoring can be time-consuming and is open to risks, including data duplication and transcription errors. That’s why at Microgenetics, we’ve developed SmartControl as a new way for you to capture, manage and track your data, making your lab paperless, efficient and smart.

    SmartControl makes it easy for users to meet regulation, enhance data integrity and take better environmental monitoring decisions. It’s compliant with FDA 21 CFR Part 11 and GMP Annex 11, yet simple to use. Booking in a plate takes just 6 seconds, with in-depth analysis and reporting at your fingertips.

    Plus, it’s easy to set up. Being a cloud-based software, testing and validation is completed by Microgenetics and there’s no physical server installation. This means you could have the software running in your facility in just 6 weeks. Any subsequent updates – whether this means new and improved features, or updates in line with new regulation - are also hassle-free, too.

    Are you ready to bring your lab into the future?



    STERIS

    Exhibitors
    http://www.sterislifesciences.com

    STERIS Life Sciences is your trusted partner in contamination control. For over 100 years, STERIS has been a global leader and expert in the industries of sterilization, cleaning and infection control.

    Today, we continue to build on this heritage by providing the products and resources you need throughout every step of your process. From innovation to results, our comprehensive portfolio of products and services is designed to meet your needs.

    With offices located worldwide and technicians in over 100 countries, you can count on us to be where you are when you need us, every step of the way. Trust STERIS Life Sciences to help you create a healthier and safer world.


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    Hilton London Kensington

    179-199 Holland Park Avenue
    London W11 4UL
    United Kingdom

    Hilton London Kensington

    At the heart of the Holland Park district, our hotel is 10 minutes from Westfield London shopping center. We're blocks from Shepherd's Bush Underground station, linking to central London, and Kensington Palace and Gardens are two miles from us. Enjoy 24-hour access to our fitness center.

     
    Join us in WestEleven for hearty buffet breakfast, a great way to start the day! Our Avenue Bar and Lounge serves light bites throughout the day as well as a delicious, seasonal dining menu.”
    HOTEL BOOKING FORM

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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, SAE Media 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@saemediagroup.com

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