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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 info and the key insights.

Read more

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 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.

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

BROCHURE 

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

Request

Please fill in your e-mail address below and we will process your request in a moment.

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