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

Less than a month to go! Grab your ticket now!

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. 
 
Here's a taste of who's attending:

Roche
Kite Pharma
AstraZeneca
NHS England
Bayer
Boehringer Ingelheim
GSK
Oxford BioMedica 
 

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 agenda

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8:00

Registration & Coffee

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9:00

Chairman's Opening Remarks

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

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9:10

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

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

  • 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
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    9:50

    Applying airfl ow visualisation with Annex 1 and regulations

    Luigi Scaffidi

    Luigi Scaffidi, Manager Qualification / Validation, Aseptic Quality Assurance, Boehringer Ingelheim Pharma GmbH & Co. KG

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    10:30

    Morning Coffee

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    11:00

    Implementation of Biofluorescence Particle Counters to Replace Traditional EM Methods

    Thais Vilgren

    Thais Vilgren, Project Manager, Novo Nordisk

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    11:40

    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
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    12:20

    Networking Lunch

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    13:20

    Applying airflow visualisation with Annex 1 and regulations

    Marco Cuomo

    Marco Cuomo, Manager Applied Technology Innovation, Novartis

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    14:00

    Cleanroom disinfectant and development as part of CCS validation

    Matthew Allum

    Matthew Allum, Asst Engineer, MeiraGTx

  •  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
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    14:40

    Afternoon Tea

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    15:10

    Cleanroom disinfectant and development as part of CCS validation

    Florian Grundmann

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

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    15:50

    Chairman’s Closing Remarks and Close of Day One

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    8:00

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

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    9:10

    Enhancing Contamination Control in Allogenic Cell Therapy facilities

    Tishwant Kanwarjit, Director of QA & QP , Autolus Ltd

  • 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
  • clock

    9:50

    Visualising risks of airborne contamination of Sterile medicinal products in Aseptic process Filling

  • 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
  • Marc Steffens

    Marc Steffens, Global Project Manager , Roche

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    10:30

    Morning Coffee

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    11:00

    Container Closure Integrity and Stability Testing for Rigid Containers

    Jennifer Gygl

    Jennifer Gygl, Expert Technical Consultants, Nelson Labs

  •   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
  • clock

    11:40

    Contamination Control for ATMPs

    Leslie Southam, Director- Quality Assurance, Oxford BioMedica

    • 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

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    12:20

    Networking Lunch

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    13:20

    USP Focus on Aseptic Processing for Small Molecules

    Christian Zeine

    Christian Zeine, Scientific Affairs Manager, US Pharmacopeia

  • 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
  • clock

    14:30

    Establising Finish-Fill for ATMPs

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

    Leslie Southam, Director- Quality Assurance, Oxford BioMedica

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    15:10

    Afternoon Tea

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    15:40

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

    Mary Doody

    Mary Doody, Associate Director of Quality, MSD

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    16:10

    Chairman’s Closing Remarks and Close of Day Two


    Senior Manager QC Microbiology
    GSK
    Scientific Affairs Manager
    US Pharmacopeia
    Sterilization Capability Owner
    AstraZeneca
    QC Manager
    Oxford BioMedica plc
    CEO
    Pharmabotix AG
    Team Lead Cleaning Validation, MSAT
    F. Hoffmann-La Roche Ltd.
    Senior Director-CMC
    Iterion Pharmaceuticals
    Head of GMP compliance and Aseptic Processing support
    Franz Ziel GmbH
    Associate Director- Site Microbiology Lead
    MSD
    Expert Technical Consultants
    Nelson Labs
    Senior Technical Service Manager
    Steris Corporation
    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
    Asst Engineer
    MeiraGTx
    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

    Speaker Presentation - 2022 James Drinkwater

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    Speaker Presentation

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    Past Attendee List

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    Speaker Presentation

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    Exhibitors


    Cherwell

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

    Cherwell is a leading supplier of prepared microbiological media and environmental monitoring instrumentation for the pharmaceutical and related industries. Cherwell manufactures and supplies cleanroom microbiology solutions across the UK and Europe from their site in Bicester, Oxfordshire.

    With over 50 years’ experience, Cherwell understands that environmental monitoring is a critical element to any manufacturing process within the pharmaceutical industry. Therefore, Cherwell focuses on supplying high quality, reliable products, that are supported by expert knowledge. The product portfolio available from Cherwell enables professionals to make informed decisions about their cleanroom environment. Which allows them to select the best suited solutions to manage risk associated with a robust contamination control strategy.

    Cherwell has been manufacturing prepared microbiological media, used in environmental monitoring, sterility testing and process validation, under the Redipor® name since the early 1980s. Flexibility and a keen understanding of the needs of the pharmaceutical and associated industries are key to Redipor’s philosophy.

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

    The new BioAerosol Monitoring System (BAMS) is the first truly portable continuous, real-time microbial monitor. BAMS is an airborne particle counter that uses Laser-Induced Fluorescence to differentiate biologic from inert particles, with viable particles emitting fluorescence.

    As environmental monitoring experts, Cherwell ensure that they work in partnership with customers, discussing and offering the best solution to help them meet stringent sterile medicinal product manufacturing standards.



    Raumedic

    Exhibitors
    http://www.raumedic.com

    RAUMEDIC serves Pharma / Biopharma / Cell and Gene Therapy - with first class tubing for fluid transfer and fluid handling applications.

    Benefit from Raumedic's 70+ years of experience as a single source tubing supplier - with an in-house materials department, in-house product development and tried and trusted manufacturing expertise at five different production sites in three countries.

    With Raumedic as your supplier, you can count on:

    Standards compliance and validation

    Biocompatibility

    Low extractable values

    Increased flow rates / Cell Growth yield

    Discover innovative tubing from Raumedic - In stock and ready to ship!

    • Standards compliance and validation

    • Biocompatibility

    • Low extractable values

    • Increased flow rates / Cell Growth yield

    • Platinum cured Silicone Tubing

    • Platinum cured Braided Silicone Tubing (high pressure)

    • Thermoplastic Elastomer Tubing (TPE)

    • Tubing sets - bespoke customer design



    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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    Opening Hours: 9.00 - 17.30 (local time)
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