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5th Annual Aseptic Processing Hybrid Summit

  • 18th – 19th November 2021
  • Hybrid flag Hybrid Munich, Germany
  • Munich Marriott Hotel Berliner Str. 93, 80805

The Spin-off of the Aseptic Processing Hybrid Summit (#5VLAP), 18-19 November 2021 in Munich, Germany in the frame of the #VLGeneCell, Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit.

Welcome to learn more about the current changes in the European regulations, emerging technologies and innovation in pharmaceutical manufacturing, aseptic fill and finish, quality control, engineering and container development, robotics in aseptic processing, gloveless isolators and dose control, commercial sterilization and a lot more

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At the Spin-off of the 5th Annual Aseptic Processing Hybrid Summit (#5VLAP), 18-19 November 2021 in Munich, Germany, key topics will be discussed by some of the industry’s leading experts. The #5VLAP, hosted in 2021 virtually and onsite in the frame of the Gene and Cell Therapies: CMC, CGT & Vector Manufacturing Summit, will give you a broad overview of current changes in the European regulations, modern technical trends, emerging technologies and innovations.

Who should attend

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

  • Cleaning Validation
  • Drug Development
  • Toxicology
  • Sterilization
  • Fill and Finish
  • QA/QC
  • R&D
  • Risk Management
  • Biotechnology
  • Medical Devices
  • Nanomaterials
  • Bioprocess Research and Development
  • Parenterals
  • Packaging and Labelling
  • Pharmaceutical Process and Technology
  • Process Monitoring and Control
  • Process Analytics
  • Product Innovation
  • Engineering
  • Container Development
  • CMC
  • ADC/HPAPI Aseptic Processing fill and finish
  • Regulatory Affairs
  • Stability
  • Standardisation Science
  • Vaccine/Antibody/Cell Manufacturing
  • Formulation
  • Lyophilisation/ Freeze-Drying
  • Processed foods
  • Food packaging
  • Commercial sterilization

Register now and get 100€ discount

The Early Bird Offer expires in 3 days!

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

  • Implementation of quality risk management
  • Final fill with SU Equipment
  • ADC/HPAPI aseptic processing fill and finish
  • Robotics in aseptic processing
  • Gloveless Isolators and dose control
  • The evolution of aseptic technologies
  • Occupational safety requirements
  • Aseptic packaging: machinery methods of filling and materials
  • Multi-product facilities

Register now and get 100€ discount

The Early Bird Offer expires in 3 days!

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

Merck KGaA

Simone is a Regulatory Expert at Merck Life Science and provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on Single-Use Technology (SUT). Over the last years, Simone supported biopharmaceutical drug manufacturer’s implementation of SUT in their manufacturing process.

With her deep understanding of SUT market needs and industry trends, she acts as a subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in Microbiology. 

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

STERIS Corporation

Walid El Azab is an industrial pharmacist, a qualified person and a Lean Six Sigma green belt. He is a technical services manager for STERIS Life Sciences. He provides technical support related to cleaning, disinfectants, sterility assurance and process validation. Finally, he leads audits at manu­facturer sites and workshops to improve processes and inspection readiness level. Walid is a lecturer at a pharmacy and medicine university. He has published different articles and book chapters, and he is also part of working groups on sterilisation and EU GMP Annex 1 guideline revision. He is a plan­ning committee member of the Annual PDA Conference on Pharmaceutical Microbiology (12th and 13th editions), and part of the editorial committee of the PDA Letter. Walid is an observer member of the ISPE Belgium affiliate board. Finally, he is secretary of the Belgium Qualified Person Association.

Matthias Angelmaier, DE

Global Product Manager Isolator and Process Technology

Syntegon

Matthias Angelmaier has a bachelor’s degree in industrial and mechanical engineering as well as a master’s degree in business development. He joined Syntegon Technology GmbH in 2009. During his first 3 years, he was a project manager for handling complex customer projects. Since 2012, he is the globally responsible product manager for barrier systems, isolator and process technology. His expertise includes process engineering, sterilization, bio-decontamination, aseptic and high-potent Isolator applications, glove testing systems as well as topics related to advanced aseptic processing. He is a frequent speaker on international symposia and conferences including organizations like ISPE and PDA

Dr. Silvia Aldi, CH

Product Manager for Cell & Gene Therapy

SKAN AG

Dr. Silvia Aldi is a cell and gene therapy bioprocessing and translational research expert. Currently, she is a cell and gene product manager at SKAN AG, where she leads the product development strategies for the manufacturing of cell and gene therapies.

She has more than 10 years of expertise in R&D management in academic settings, working in the top research centre worldwide (Karolinska Institutet in Sweden and Weill Cornell Medicine in USA), where she gained extensive scientific knowledge in cell and gene processes.

Silvia worked for six years at Karolinska Institutet as assistant professor and research coordinator, where she coordinated international and interdisciplinary research programs focused on the validation of drug targets for cardiovascular diseases and medical device for the diagnosis of autoimmune disease.

She has a master's degree, a BS in cell and molecular biology, and received her PhD in molecular medicine from the University of Siena, Italy.

Dr. Ruthger van Zwieten, NL

Sales Director

Picarro Inc.

Ruthger van Zwieten received his PhD in gene and cell therapy from the University of Lausanne, Switzerland and developed the research plan for a pharmaceutical company before transitioning into business development roles in natural sciences companies. He has been with Picarro since November 2019 and has intimate knowledge of the Picarro H2O2 CRDS pharma analyzer which has a major role in the filling of biopharmaceuticals.

Ken Nagai, JP

Deputy General Manager / Total Design and Project Department

Airex Co.,Ltd.

Ken Nagai works as a deputy general manager of the total design and project department for Airex, an isolator/decontamination equipment company for the pharma and ATMP industry. His responsibility includes project management, international expansion, new business creation, strategic planning, and production improvement for the organisation. Previously, he experienced new business development in a $10B organisation as a product line manager. He also worked in a consultancy, applying the Toyota production system to many different manufacturing organisations as a consultant. Ken has a bachelor’s degree from the University of Tokyo and an MBA from University of Notre Dame.

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Dr. Simone Biel, DE

Senior Regulatory Consultant

Merck KGaA

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

STERIS Corporation

Matthias Angelmaier, DE

Global Product Manager Isolator and Process Technology

Syntegon

Dr. Silvia Aldi, CH

Product Manager for Cell & Gene Therapy

SKAN AG

Dr. Ruthger van Zwieten, NL

Sales Director

Picarro Inc.

Ken Nagai, JP

Deputy General Manager / Total Design and Project Department

Airex Co.,Ltd.

BROCHURE  

Request the Spin-off of the 5th Annual Aseptic Processing Hybrid Summit brochure and find out the latest topics and ideas that will be shared. 

Request

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What our
participants
are saying

I found it truly productive to discuss in Q&A session with other specialists involved within the scope of risk management. Furthermore, I am impressed by the team's efficiency and in the communication before, during, and after the event. It was a pleasure to participate and would be honoured to get a chance to speak again.

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Attendee

This event was so well attended and provided a cool platform for pharma professionals to discuss and debate the Robotics in aseptic processing. Very inspiring conference. I enjoyed the panel as well. Also, the Chairman did an excellent job to keep all speakers on track. This event was well worth attending.

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Attendee

Very accommodating logistics team relaxed and enjoyable environment for the attendees as well as the vendors. The exposure level was as expected, including the website and printed materials exposure, placement of our advertising roll-ups, or booth set up. The staff was very considerate, responsive, and kind.

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