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6th Aseptic Processing Summit

  • 17th – 18th November 2022
  • Austria flag Austria Online & Vienna

The demand of aseptic manufacturing is rising, and, therefore, the challenges of aseptic processing will continue to grow in complexity.

The changes to Annex 1 are bringing new obstacles to pharma company operations that should be overcome from both technical and organisational perspectives.

At the 6th Aseptic Processing Summit on November 17-18, 2022, experts from the industry will highlight the requirements to robust aseptic processing, targeted implementation strategies, recent experience on establishing aseptic manufacturing processes for ATMPs and vaccines in particularly, and adoption of innovative aseptic processing technologies, including robotics.

The #VLaseptic brochure contains additional details and the key insights, as well as information about the concurrent #VLGeneCell. 

Read more

About the 6th Aseptic Processing Summit + Gene and Cell Therapies (#VLaseptic & #VLGeneCell)

The demand of aseptic manufacturing is rising, and, therefore, the challenges of aseptic processing will continue to grow in complexity.

Ensuring product quality at faster speed and with better flexibility is becoming the key priority.

The Annex 1 of the EU GMP Guide "Manufacture of Sterile Medicinal Products" is considered to be the most important European regulatory standard for the manufacture of sterile pharmaceutical products. The changes to Annex 1 are bringing new obstacles to pharma company operations that should be overcome from both technical and organisational perspectives. The broader insights, as well as concrete practical interpretation and implementation of many aspects of the draft Annex 1, should be aligned with and correspond to regulators considerations and industry expectations.

The changes related to quality risk management, contamination control strategies, and environmental and process monitoring seem to be the most critical for the industry. Specific technologies and processes are required to benefit manufacture of biopharmaceutical products.

The 6th Aseptic Processing Summit on November 17-18, 2022, will bring together pharmaceutical developers, manufacturers, CDMOs, suppliers, engineering companies, and experts from the field to highlight:

  •  Regulatory updates and expectations on compliant aseptic production
  •  Important insights, best practices, and critical considerations on managing aseptic operations
  •  Innovative aseptic processing technologies and techniques
  •  Aseptic manufacturing processes for ATMPs, including cell and gene therapies, and mRNA vaccines
  •  Advances in ATMP facility design, and other emerging subjects, aimed to:
    •  Achieve improvement in aseptic processing of sterile biopharma products
    •  Ensure safe highly potent aseptic production for manufacturers
    •  Provide patients with contaminant-free drug products that are effective and safe

Join the #VLaseptic event to explore industry challenges, standards, and advancements, as well as develop new partnerships and showcase innovative technologies at the premium conference and exhibition on November 17-18, 2022, and take advantage of visiting the concurrent #VLGeneCell.

Who should attend

Chief Executives, Directors, Vice Presidents, Heads, Leaders, Senior Managers, Scientists, Chemists, Engineers, and Fellows specialising in:

  • Advanced Therapy Medicinal Products (ATMP)
  • Antibody
  • Antibody-Drug Conjugates (ADCs)
  • Artificial Intelligence
  • Aseptic Container-Closure Systems
  • Aseptic Filling
  • Aseptic Manufacturing
  • Aseptic Operations
  • Aseptic Processing
  • Aseptic Processing Equipment
  • Aseptic Production
  • Autoclave Cycles
  • Automation
  • Bags
  • Barriers
  • Bioburden
  • Biologics
  • Bioprocess
  • Biosimilars
  • Biotechnologies
  • Cell and Gene Therapies (CGTs)
  • Cell Manufacturing
  • Chemistry, Manufacturing & Controls (CMC)
  • Clean-Room Operations
  • Cleaning
  • Cleaning Validation
  • Clinical Manufacturing
  • Cold Chain
  • Commercial Sterilisation
  • Container Development
  • Contaminant-Free Drug Products
  • Contamination Control
  • Continuous Manufacturing
  • Continuous Processing
  • Coronavirus
  • COVID-19
  • Depyrogenation
  • Disinfection
  • Drug Development
  • Drug Safety
  • Dry-Heat Sterilisation
  • Engineering
  • Engineering
  • Environmental Monitoring
  • Enzyme-Indicators
  • Ethylene Oxide Sterilisation
  • Facilities
  • Facility Design
  • Fill and Finish
  • Filters
  • Final Filling
  • Food Packaging
  • Formulation
  • Freeze Drying
  • Generics
  • Good Manufacturing Practice (GMP)
  • High Potent Processing
  • Highly Potent Active Pharmaceutical Ingredients (HPAPI)
  • Highly Potent Substances
  • Hydrogen Peroxide (H2O2)
  • Industrial Hygiene
  • Integrity Testing
  • Isolation Technologies
  • Isolators
  • Labelling
  • Leak Testing
  • Lesser-Used Techniques
  • Lyophilisation
  • Machine Learning
  • Media Fills
  • Medical Devices
  • Messenger RNA (mRNA)
  • Microbiological Lethality
  • Microbiologic
  • Modular Filling
  • Nanomaterials
  • Packaging Technology
  • Parenterals
  • Pharmaceutical Process
  • Pharmaceutical Technology
  • Pharmaceutical Water
  • Pharmaceuticals
  • Predictive Modelling
  • Process Analytics
  • Process Control
  • Process Monitoring
  • Process Simulation
  • Process Validation
  • Processed Foods
  • Product Innovation
  • Pure Steam Generators
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Quality Risk Management
  • Radiation
  • Radiation Sterilization
  • Rapid Micro Testing
  • Regulatory
  • Regulatory Affairs
  • Research & Development (R&D)
  • Restricted Access Barrier Systems (RABS)
  • Risk Management
  • Robotics
  • Single Use Manufacturing Systems
  • Single-Use Components
  • Small Scale
  • Stability
  • Sterile Biopharma Products
  • Sterile Medicinal Product
  • Sterility Testing
  • Sterilisation
  • Supply Chain
  • Syringes
  • Terminal Sterilisation
  • Testing
  • Toxicology
  • Tubing
  • Vaccines
  • Validation
  • Virtual Reality
  • Water for Injection

REQUEST A BROCHURE

To request an agenda for this Summit, please complete the details below. We will send you the agenda via email.

KEY PRACTICAL LEARNING POINTS

  • Overcoming aseptic processing challenges in the context of Annex 1 (Manufacture of Sterile Medicinal Products)
  • Leveraging regulatory concerns, expectations, and embracing innovative aseptic processing technologies
  • Avoiding pitfalls in aseptic manufacturing inspections, and discovering the future of GMPs in aseptic processing
  • Overcoming hurdles to adopt new technologies in the aseptic processing of sterile medicinal products and to achieve safe highly potent aseptic production
  • Better ways to model, predict, and control aseptic processes with automation, robotics, virtual reality, artificial intelligence, machine learning, and predictive modelling
  • Design, development, and implementation of components in the aseptic manufacturing processes
  • Addressing contamination control issues and establishing a robust contamination control strategy, enhanced with tech advances
  • Critical evaluation of adopting enzyme H2O2 indicators in aseptic processing environments
  • Navigating highly potent manufacturing requirements
  • Developing and qualifying aseptic manufacturing processes for ATMPs, including cell and gene therapies, and mRNA vaccines
  • Accepting new risk-based approaches to process design and control
  • Exploring the key insights and implementations for the sterility assurance of the finished products
  • Bringing higher productivity with continuous process manufacturing and improving efficiency of aseptic processes
  • Critical considerations on clinical or small-scale aseptic manufacturing and facilities of the future
  • Ensuring product quality at faster speeds and with more flexibility through a partnership of manufacturers, suppliers, and regulators

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Richard Denk has studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, phar­maceutical engineering, quality control at the University of Applied Sciences in Albstadt/Sigmaringen Germany. Richard works at SKAN AG, headquartered in Allschwil, as the head of sales containment. He founded the expert Con­tainment Group of the ISPE DACH eight years ago. The Containment Group published the Containment Manual in September 2015. Richard has spent nearly 20 years working with highly active/highly hazardous substances and has developed the containment pyramid.

Dr. Simone Biel, DE

Senior Regulatory Consultant / Life Science, Quality & Regulatory Management

Merck KGaA

Simone Biel is a Senior Regulatory Consultant and provides regulatory expertise to our customers and internal stakeholders with a focus on Single-Use Technology and filtration. Over the years, Simone has supported biopharmaceutical drug manufacturer’s implementation of Single-Use Technology in their manufacturing process and gained a deep understanding of market needs and industry trends in this field. Her objective is to ensure that product performance meets quality and regulatory requirements.

Simone holds a Ph.D. from the University of Frankfurt in Microbiology.

Donald Singer, US

Senior Microbiology Technical Consultant, North America

Ecolab

Don Singer is a senior microbiology technical consultant, North America, for Ecolab, and a fellow in the American Society for Quality. He was formerly a GSK senior fellow. Don has been chair of the USP general chapters - microbiology committee of experts and a member since 2000. He is a certified GMP professional, a certified specialist microbiologist, a member of the European pharmacopeia group 1 microbiology committee, and a certified six sigma green belt. Don is also an adjunct professor in the biopharmaceutical quality graduate program at the University of Maryland, Baltimore County. Don’s career spans over 40 years of research and quality control.

Chris Berridge, UK

Global Technical Consultant, Bioquell Specialist for

Ecolab Life Sciences

Chris Berridge is a global technical consultant, Bioquell specialist for Ecolab Life Sciences. He has over seven years of experience working in graded cleanrooms for pharmaceutical manufacturing as well as biosafety laboratories and biomedical facilities. He is a bio-decontamination specialist and subject matter expert on Bioquell technology, products, and services and their uses in the life sciences and healthcare markets. He also manages projects focussing on the implementation of Bioquell’s more complex integrated decontamination systems, including detailed design, building of bespoke documentation, and managing the validation and other siteworks. Chris is also an industry speaker at technical conferences and in webinars.

Amnon Eylath, US

VP Head of Global Quality

Minovia Therapeutics Ltd

Amnon Eylath is a seasoned quality leader who's experienced in the complete life cycle of biological and small molecule drug development, from discovery through nonclinical and tox studies, clinical trials, process and method development, GMP manufacturing, validation, regulatory submissions, and US/EU/MHRA commercial product approvals. Amnon has direct experience with cell and gene therapy and with developing and troubleshooting aseptic processes, including design and fabrication of isolators and the implementation and validation of highly effective decontamination and sterilisation technology.

Amnon has worked at various capacities in international companies, such as Amgen, Ely Lilly, and Genzyme-Sanofi, as well as at cell therapy companies such as Cellcore Therapies, Histogenics, and Minovia Therapeutics. Currently, Amnon is the global vice president of quality at Minovia Therapeutics, working out of the Massachusetts site and developing quality systems and implementation of continuous improvement methods to the development of clinical cell therapy processes.

Fabian Stutz, DE

CEO

Pharmabotix AG

Fabian Stutz is the CEO and head of sales with Pharmabotix AG, a company that provides clients with innovative robotics and automation solutions for the pharmaceutical industry. From building an effective team to maintaining a large customer network, Fabian is adept at driving business development while delivering exceptional service to customers with a direct communications approach. He is passionate about trying new ideas and providing honest feedback on feasibility to ensure customer satisfaction.

Jeremiah Genest, US

Head of Quality Management Systems

Amylyx Pharmaceuticals

Jeremiah Genest is a quality professional with over 20 years of experience in the pharmaceutical industry. He's based in Boston, MA, and currently employed at Amylyx Pharmaceuticals as the head of quality management systems. His past work includes Takeda, Sanofi, Thermo Fisher, and Vertex Pharmaceuticals. His experiences within quality systems include builds for new organisations, remediation under consent decree, and full transformations at more established companies.

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Dr. Simone Biel, DE

Senior Regulatory Consultant / Life Science, Quality & Regulatory Management

Merck KGaA

Donald Singer, US

Senior Microbiology Technical Consultant, North America

Ecolab

Chris Berridge, UK

Global Technical Consultant, Bioquell Specialist for

Ecolab Life Sciences

Amnon Eylath, US

VP Head of Global Quality

Minovia Therapeutics Ltd

Fabian Stutz, DE

CEO

Pharmabotix AG

Jeremiah Genest, US

Head of Quality Management Systems

Amylyx Pharmaceuticals

BROCHURE 

Request the 6th Aseptic Processing Summit brochure and find out the latest topics and ideas that will be shared.

Request

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What our
participants
are saying

Fantastic opportunity to network with colleagues and explore the best practices related to aseptic processing

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Attendee

There was well-explained the state of aseptic processing, trends, strengths and weakness, opportunities and threats, regulatory expectations, areas for improvement, and more. I would definitely attend again.

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PAST

Attendee

There was well-explained the state of aseptic processing, trends, strengths and weakness, opportunities and threats, regulatory expectations, areas for improvement, and more. I would definitely attend again.

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PAST

Attendee

The speakers presented some important best practices, and this is expected to significantly improve the manufacturing environment of pharmaceuticals. It worth to join.

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Attendee