Description

Aseptic Processing Technology event will overview regulatory updates and their implementation, main challenges and overcome consideration, new technologies and innovations to avoid mistakes and ensure safe highly potent aseptic production for both sides - manufacturer and patient. This event will help you improve your aseptic processes and address contamination control issues that you may encounter.

The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%.

At the event you will have the opportunity to discourse and to network with peers involved in pharmaceutical manufacturing, aseptic fill and finish, quality control, engineering, and container development. Key topics in Aseptic Processing will be discussed by some of the industry’s leading lights.

During this event, you will learn about environmental monitoring systems, facility cleaning and disinfectant qualification, aseptic cleanroom operations, filtration, sterilization, aseptic process simulation, and regulatory requirements. Hands-on activities will include gowning qualification, facility cleaning and disinfection, aseptic technique qualification, aseptic process simulation, and microbial identification.

Key Practical Points

  • The Evolution of Aseptic Technologies
  • Multi-Product facilities
  • Regulatory framework. Aseptic Processing principles.
  • Antibody Drug Conjugates / HPAPIs production
  • Lyophilization of highly potent products and aseptic processing.
  • Occupational safety requirements
  • Aseptic process development, validation and evaluation.
  • Aseptic processing simulation
  • Highly potent facility design and engineering considerations
  • Isolator Technology use in aseptic processing for loss minimization/elimination.
  • Overcoming technical challenges in decontamination processes and material transfers.
  • Cleaning and disinfection programs for aseptic facilities.
  • Microbiology concepts and techniques
  • Cross contamination prevention and control for highly potent products.
  • Robotics in aseptic processing
  • Gloveless Isolators and dose control
  • Final fill with SU Equipment
  • ADC/HPAPI aseptic processing fill and finish
  • Challenges for manufacturers in cell and gene therapy production systems
  • Airflow visualization for contamination risks assessment.
  • Implementing containment technologies in aseptic processing
  • Boosting sterilization: successful strategies, advanced technologies implementation.
  • Cleaning automation and technologies.
  • Gowning: procedures, training, personnel qualification.
  • Microbiology techniques use in aseptic processing.
  • Integrating sanitization techniques to empower contamination control.
  • Filtration: filter integrity testing in aseptic processing.
  • Single-use systems implementation.
  • Assess airflow visualization to limit risk for product contamination
  • Describe the importance of filter integrity testing for aseptic operations
  • Cleanrooms for the Annex 1 updates
  • Implementation of quality risk management

Who should attend?

Members of board, C-level, Senior Vice Presidents, Vice Presidents, Directors and Heads of departments from pharmaceutical/biotechnology industry / industries involved in:

  • Bioprocess Research
  • and Development
  • Biotechnology
  • Container Development
  • CMC
  • Drug Development
  • Engineering
  • Fill and Finish
  • Freeze-Drying
  • Formulation
  • Medical Devices
  • Nanomaterials
  • Parenterals
  • Packaging and Labelling
  • Pharmaceutical Process and Technology
  • Process Monitoring and Control
  • Process Analytics
  • Product Innovation
  • Packaging
  • QA/QC
  • R&D
  • Risk Management
  • Regulatory Affairs
  • Stability
  • Standardisation Science
  • Sterilization
  • Vaccine/Antibody/Cell Manufacturing
  • Validation
  • Licensing
  • Lyophilisation

Keynote Speakers

Slide FEATURED Walid
El Azab
Walid El Azab is an Industrial pharmacist and a Qualified Person (QP). He is a Senior Manager Technical Services for the Life Sciences Division of STERIS Corporation. SENIOR MANAGER TECHNICAL SERVICE AT STERIS
Slide FEATURED Kate
Coleman
Kate is a Quality professional with 18 years experience in the Pharmaceutical Industry across several platforms including Biologics, Sterile Fill Finish, High Potency oncology and Solid Oral Dose products. DIRECTOR/SENIOR CONSULTANT QUALITY AND COMPLIANCE AT PHARMALEX
Slide FEATURED Richard
Denk
Richard Denk has studied mechanical engineering and did examination on Experts of GMP, Qualification and Validation, Pharmaceutical Auditing, Pharmaceutical Engineering, Quality Control on the University of Applied Sciences in Albstadt/Sigmaringen Germany. SENIOR CONSULTANT ASEPTIC PROCESSING & CONTAINMENT AT SKAN AG
Slide FEATURED Sue
Behrens
Sue Behrens joined KGI as the George B. and Joy Rathmann Professor in Bioprocessing and Director of the Amgen Bioprocessing Center in 2019. Sue is also President, SB Executive Consulting, LLC providing technical and regulatory support for development and manufacturing of biologic and vaccine products. PROFESSOR AT KECK GRADUATE INSTITUTE
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