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Aseptic Processing
18 September - 19 September 2023
Aseptic Processing

Conference Overview


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.

 

FEATURED SPEAKERS

Christian Zeine

Christian Zeine

Scientific Affairs Manager, US Pharmacopeia
Dan Kynaston

Dan Kynaston

Sterilization Capability Owner, AstraZeneca
Florian Grundmann

Florian Grundmann

Team Lead Cleaning Validation, MSAT, F. Hoffmann-La Roche Ltd.
James Drinkwater

James Drinkwater

Head of GMP compliance and Aseptic Processing support, Franz Ziel GmbH
Jennifer Gygl

Jennifer Gygl

Expert Technical Consultants, Nelson Labs
Leslie Southam

Leslie Southam

Director- Quality Assurance, Oxford BioMedica
Luigi Scaffidi

Luigi Scaffidi

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

Marco Cuomo

Manager Applied Technology Innovation, Novartis
Petra Merker

Petra Merker

Manager - Biological Quality Control, Bayer
Thais Vilgren

Thais Vilgren

Project Manager, Novo Nordisk
Tishwant Kanwarjit

Tishwant Kanwarjit

Director of QA & QP , Autolus Ltd

Chris Hutchins

Senior Manager QC Microbiology, GSK
Chris Hutchins

Christian Zeine

Scientific Affairs Manager, US Pharmacopeia
Christian Zeine

Dan Kynaston

Sterilization Capability Owner, AstraZeneca
Dan Kynaston

Dipesh Sonar

QC Manager, Oxford BioMedica plc
Dipesh Sonar

Fabian Stutz

CEO , Pharmabotix AG
Fabian Stutz

Florian Grundmann

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

Gowri Sukumar

Senior Director-CMC, Iterion Pharmaceuticals
Gowri Sukumar

James Drinkwater

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

James is based in the UK with a global support role at F Ziel who are the largest Isolator and RABS
manufacturer in Germany. James is the Ex-Chairman (10 years) and current Head of the Not-forProfit PHSS: Pharmaceutical & Healthcare Sciences Society Aseptic processing special interest group
and Co-lead of the EU GMP Annex 1 implementation and Contamination Control Strategy (CCS)
Focus groups. Working experience includes 10 years in radio pharmaceutical manufacturing
(Amersham-GE Healthcare) and over 30 years working in sterile medicinal product manufacturing
support where increasingly aseptic processing applies to ATMPs, particularly Gene and Cell
therapies. James is a qualified pharmaceutical process engineer with addition education in
pharmaceutical microbiology and a subject matter expert in Barrier Technology (Isolators and RABS)
and Bio-decontamination with Hydrogen peroxide vapour (H202-VHP). James is also a Member of
ISPE and Pharmaceutical Quality Group UK (PQG)

Jan-Jaap Schot

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

Jennifer Gygl

Expert Technical Consultants, Nelson Labs
Jennifer Gygl

Jim Polarine

Senior Technical Service Manager, Steris Corporation
Jim Polarine

Leslie Southam

Director- Quality Assurance, Oxford BioMedica
Leslie Southam

Leslie Southam (BSc Hons) has 8 years’ experience working in QA for two ATMP manufacturers, and 14 years working in QA within the pharmaceutical industry as a whole. Leslie’s current role is QA Manager, Projects for Oxford Biomedica who are a clinical and commercial stage manufacturer of lentiviral vectors used in both in-vivo and ex-vivo gene/immunotherapy applications including Kymriah (World’s first commercial cell therapy product) and AZD1222 (Oxford University / AstraZeneca COVID-19 vaccine). In the role he is the quality lead on the project for the design, construction and qualification of a new, state of the art 7200m2 GMP manufacturing facility, on-site manufacturing start-up activities for drug substance manufacturing and Oxford Biomedica’s first in-house sterile fill finish line for drug product. This is the second facility design and construction project Leslie has been involved in during his time at Oxford Biomedica. Prior to this Leslie worked in various roles within QA at Oxford Biomedica supporting in-house and contract manufacturing operations. Leslie has also been the QA Manager for a start-up cell therapy company who are using innovative technologies to develop the next generation of immunotherapy products. In that role he was primarily tasked with creating and implementing the company’s quality management system to enable the company to advance its products into early phase clinical trials.

Luigi Scaffidi

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

Marc Steffens

Global Project Manager , Roche
Marc Steffens

Marco Cuomo

Manager Applied Technology Innovation, Novartis
Marco Cuomo

Mary Doody

Associate Director of Quality, MSD
Mary Doody

Matthew Allum

Asst Engineer, MeiraGTx
Matthew Allum

Petra Merker

Manager - Biological Quality Control, Bayer
Petra Merker

Petra Merker is holding a PhD with emphasis on Molecular Biology and Microbiology from the Freie University Berlin and is currently working as a "Biological Quality Control Expert" at Bayer in Berlin.
She is supporting aseptic production processes as well as new technologies and filling lines.
After her Post-Doc at the Max-Planck-Institute for Molecular Biology in Berlin she joined Schering/ Bayer by implementing a Rapid Microbiological Method, a “Real-Time” PCR Technology for the detection of specified microorganisms in pharmaceutical preparations.
She has been a group leader of several QC laboratories within Biological QC at Bayer, like Sterility testing, Monitoring and the Identification of germs.
Petra is a member of different industry working groups, who aim to support the implementation of Rapid Microbiological Methods, esp. Alternative Monitoring Methods, like Biofluorescent Particle Counting (BFPCs)

 

Thais Vilgren

Project Manager, Novo Nordisk
Thais Vilgren

Tishwant Kanwarjit

Director of QA & QP , Autolus Ltd
Tishwant Kanwarjit

Tishwant is an eligible Qualified Person under Permanent Provisions & qualified Pharmacist with a wealth of practical experience in the manufacture of multiple dosage forms (sterile and non-sterile) including complex aseptic processes. He has worked across multiple senior positions within the NHS, FMCG and now at a start biotechnology company.
Tishwant current specialisation at Autolus is in the area Aseptic processing for sterile product manufacturing ATMPs, filling and sterility testing, working actively on projects providing support in process design, control strategies, risk based process control and monitoring for solutions in contamination and cross contamination control together with GMP compliance.
 

sponsors

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
  • clock

    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
  • clock

    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

    Gowri Sukumar

    Gowri Sukumar, Senior Director-CMC, Iterion Pharmaceuticals

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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

    clock

    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

    clock

    12:20

    Networking Lunch

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    13:20

    Robotics in Pharma-Automation

    Fabian Stutz

    Fabian Stutz, CEO , Pharmabotix AG

    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

    clock

    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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    Past Attendee List

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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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