Back

Pharma

6th Aseptic Processing Summit

  • 21st – 22nd June 2023
  • 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 June 21-22 2023, 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 June 21-22 2023, 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 June 21-22 2023, 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)
  • Analytics
  • Artificial Intelligence (AI)
  • Aseptic Processing
  • Cell and Gene Therapies (CGTs)
  • Chemistry, Manufacturing & Controls (CMC)
  • Cleaning Validation
  • Engineering
  • Environmental Monitoring
  • External Collaboration
  • Facilities Management
  • Formulation
  • Good Manufacturing Practice (GMP)
  • Highly Potent Active Pharmaceutical Ingredients (HPAPI)
  • Industrial Automation
  • Industrial, Process, Product Innovation
  • Lyophilisation
  • Maintenance
  • Manufacturing
  • Medical Devices (MD)
  • Messenger RNA (mRNA)
  • Microbiology
  • Nanomaterials
  • New Technologies
  • Operations
  • Packaging Technology
  • Parenterals
  • Process Science
  • Production
  • Quality Assurance (QA)
  • Quality Control (QC)
  • Regulatory
  • Robotics
  • Technical Science
  • Vaccines
  • Validation
  • Virtual Reality (VR)
  • ...and Others

Register by 16th of December

The Early Bird Offer expires in 10 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

  • 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

Register by 16th of December

The Early Bird Offer expires in 10 days!

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

About Speaker

Donald Singer, US

Senior Microbiology Technical Consultant, North America

Ecolab

About Speaker

Dr. Simone Biel, DE

Senior Regulatory Consultant / Life Science, Quality & Regulatory Management

Merck KGaA

About Speaker

Dr. Oliver Schläfli, CH

Senior Vice President, Global Quality

Lonza

About Speaker

Amnon Eylath, US

VP Head of Global Quality

Minovia Therapeutics Ltd

About Speaker

Dr. Thomas Schwarz, CH

Chief Commercial Officer

SiO2

About Speaker

Jeremiah Genest, US

Head of Quality Management Systems

Amylyx Pharmaceuticals

About Speaker

Dr. Gilberto Dalmaso, IT

Technical Science Director for Europe & Asia

Veltek Associates, Inc.

About Speaker

Miriam Guest, UK

Principal Microbiologist, Pharmaceutical Technology & Development, New Modalities & Parenterals Development

AstraZeneca

About Speaker

Dr. Holger Kranenburg, DE

Senior Scientist - GMP Compliance

Franz Ziel GmbH

About Speaker

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

STERIS Corporation

About Speaker

Sergio Cuevas Luján, ES

Packaging Materials Engineer

Boehringer Ingelheim

About Speaker

Pino Cabrera, ES

Consulting Manager

QUALIPHARMA

About Speaker

Christian Scarpato, IT

Process Engineering Manager

Merck Italia

About Speaker

Chris Berridge, UK

Global Technical Consultant, Bioquell Specialist for

Ecolab Life Sciences

About Speaker

Fabian Stutz, DE

CEO

Pharmabotix AG

About Speaker

Bianca Bohrer, DE

CEO

PSM GmbH

About Speaker

Dr. Sebastian Trennheuser, DE

Scientific Project Manager

PSM GmbH

About Speaker

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Richard Denk studied mechanical engineering and did an examination on experts of GMP, qualification and validation, pharmaceutical auditing, pharmaceutical engineering, and 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, and eight years ago he founded the expert containment group of the ISPE DACH. 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.

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.

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.

Dr. Oliver Schläfli, CH

Senior Vice President, Global Quality

Lonza

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.

Active volunteer with the Parenteral Drug Association (PDA), chair for the drafting of Technical Report T-56 (Application of Phase-Appropriate Quality System and cGMP), co-author for TR-65 (Technology Transfer), and former president of the New England Chapter of the PDA.

Amnon is an active volunteer with the Parenteral Drug Association (PDA), chair for the drafting of Technical Report T-56 (Application of Phase-Appropriate Quality System and cGMP), co-author for TR-65 (Technology Transfer), and prior president of the New England chapter of the PDA.

Dr. Thomas Schwarz, CH

Chief Commercial Officer

SiO2

Thomas Schwarz started his career 20 years ago at Sanofi in Frankfurt in the area of recombinant insulin manufacturing. In 2006 he moved to Novartis, where he held several management positions (in Switzerland and US) with increasing responsibility within biotech manufacturing, quality assurance, and clinical supply operations. Before joining SiO2 as chief commercial officer, he served as head of strategic planning for Takeda.

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.

Dr. Gilberto Dalmaso, IT

Technical Science Director for Europe & Asia

Veltek Associates, Inc.

Gilberto Dalmaso has over 35 years’ experience in pharmaceutical microbiology and sterility assurance, primarily with GlaxoSmithKline (GSK). Over his last five years with GSK, Gilberto led a series of initiatives implementing process analytical technologies (PAT) and rapid microbial methods (RMM) that improve quality and process understanding while yielding significant cost savings. In 2003, his laboratory gained the distinction of obtaining the world’s first rapid microbial PAT approval from the US FDA. Today, Gilberto is the technical science director for Europe and Asia for Veltek Associates Inc.

In this role, he collaborates with pharmaceutical companies and authorities to develop and implement science-based strategies and processes that utilise quality by design (QbD) principles to monitor, control, and improve the chemical, physical, and microbiological state of various production processes. With his extensive experience in sterility assurance and microbiology, Gilberto has the capability of supporting pharmaceutical manufacturers in a wide variety of aseptic processes, machinery, and methods.

Miriam Guest, UK

Principal Microbiologist, Pharmaceutical Technology & Development, New Modalities & Parenterals Development

AstraZeneca

Miriam Guest is a principal microbiologist at AstraZeneca, working in the new modalities and parenteral development group, based at their Macclesfield site in the UK. Miriam has worked in pharmaceutical development for over 20 years in a range of roles, from the microbiology laboratory executing method development to being a facility microbiologist supporting a multi-product aseptic manufacturing facility, as well as some time in formulation development. She returned to microbiology in 2012.

In recent years, she has designed and developed AstraZeneca’s “21st Century Microbiology Strategy” to innovate, industrialise, and implement technology solutions to drive efficiencies and process robustness benefits with the AZ global network. She leads the global microbiology forum at AstraZeneca, which connects microbiologists from approximately 25 sites across the globe – here she fosters a culture of collaboration to support the quality function in driving standardisation and optimisation projects. The forum is an open learning network with broad representation from other skill areas as well key contributions from microbiology.

Miriam is an active committee member of the pharmaceutical microbiology interest group (Pharmig) and represents AstraZeneca on a range of cross industry collaboration networks. Outside of work, there is rarely a quiet moment – between being a taxi driver for her two teenage daughters and walking her two dogs, she also enjoys keeping active by playing football and squeezing in gym visits where she can.

Dr. Holger Kranenburg, DE

Senior Scientist - GMP Compliance

Franz Ziel GmbH

Dr. Holger Kranenburg is a subject matter expert in vH2O2 bio-decontamination, actively involved in training platforms and writing peer-reviewed publications. With 10 years of scientific background, Holger combined his passion for science and technology through working for Franz Ziel GmbH, a manufacturer of isolator technology and GMP compliance service provider. At Ziel, Holger has been involved in numerous aseptic filling line projects as a senior scientist - GMP compliance. Being an active member of the Pharmaceutical and Healthcare Sciences Society (PHSS), Holger strives to improve knowledge on aseptic processing and aseptic containment across the pharmaceutical community.

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.

Sergio Cuevas Luján, ES

Packaging Materials Engineer

Boehringer Ingelheim

Sergio Cuevas is a well-seasoned and experienced packaging materials engineer with beyond 15 years of experience. He has developed his career in Alcon, Novartis, Sanofi, and Boehringer-Ingelheim. His roles in all of those companies in the departments of supply chain and production have provided him a wide expertise in the pharmaceutical and medical devices industries. He is specialised in packaging projects coordination thanks to a broad vision of the entire packaging lifecycle (quality assurance, validation, production, etc.). Sergio carried out different studies related to design, production, and management of packaging. He is currently studying a degree in chemistry.

Pino Cabrera, ES

Consulting Manager

QUALIPHARMA

Pino Cabrera is a senior pharmaceutical consultant with 15 years’ experience in the pharmaceutical industry. Pino has knowledge and practical experience in process and cleaning validation, equipment, utilities, facilities qualification, and risk analysis, quality system implementation, and GMP regulation compliance. As a GMP auditor, Pino has performed audits on suppliers of excipients, API and finished product manufacturers, as well as internal audits and gap analysis for GMP compliance.

Christian Scarpato, IT

Process Engineering Manager

Merck Italia

Christian Scarpato is a sterile manufacturing fill and finish expert with almost 12 years of experience in pharma companies. In the last years, he worked on the design, installation, and start-up of three new production lines (vials, cartridges, and syringes) with cutting-edge technology like isolator in Merck's Bari site. He currently leads the process engineering in Merck Bari.

He graduated with honours in chemical engineering from Federico II University of Naples.

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.

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.

Bianca Bohrer, DE

CEO

PSM GmbH

Bianca Bohrer studied pharmaceutical technology at the University of Applied Sciences in Primasens (Germany). Early on, she gained experience in GMP-compliant work, especially in the area of qualification. As a division manager for analytical chemistry and a manufacturing manager for parenterals, she was able to further deepen these skills. Since September 2014, she has been head of quality control, and since 2019 she's been the managing director of PharmBioTec GmbH, a non-profit research institute, and since 2020 she's been the managing director of Topmedicare GmbH and PSM GmbH - both §13-AMG contract manufacturers for aseptic products

Dr. Sebastian Trennheuser, DE

Scientific Project Manager

PSM GmbH

Dr. Sebastian Trennheuser is the newest member of the Topmedicare and PSM family. After studying pharmacy at the University of Freiburg (Germany), he recently completed his PhD in pharmaceutical technology at the University of Heidelberg (Germany). His focus will be scientific project management

Richard Denk, CH

Senior Consultant, Aseptic Processing & Containment

Skan AG

Donald Singer, US

Senior Microbiology Technical Consultant, North America

Ecolab

Dr. Simone Biel, DE

Senior Regulatory Consultant / Life Science, Quality & Regulatory Management

Merck KGaA

Dr. Oliver Schläfli, CH

Senior Vice President, Global Quality

Lonza

Amnon Eylath, US

VP Head of Global Quality

Minovia Therapeutics Ltd

Dr. Thomas Schwarz, CH

Chief Commercial Officer

SiO2

Jeremiah Genest, US

Head of Quality Management Systems

Amylyx Pharmaceuticals

Dr. Gilberto Dalmaso, IT

Technical Science Director for Europe & Asia

Veltek Associates, Inc.

Miriam Guest, UK

Principal Microbiologist, Pharmaceutical Technology & Development, New Modalities & Parenterals Development

AstraZeneca

Dr. Holger Kranenburg, DE

Senior Scientist - GMP Compliance

Franz Ziel GmbH

Walid El Azab, BE

Industrial Pharmacist, Qualified Person / Senior Manager Technical Services

STERIS Corporation

Sergio Cuevas Luján, ES

Packaging Materials Engineer

Boehringer Ingelheim

Pino Cabrera, ES

Consulting Manager

QUALIPHARMA

Christian Scarpato, IT

Process Engineering Manager

Merck Italia

Chris Berridge, UK

Global Technical Consultant, Bioquell Specialist for

Ecolab Life Sciences

Fabian Stutz, DE

CEO

Pharmabotix AG

Bianca Bohrer, DE

CEO

PSM GmbH

Dr. Sebastian Trennheuser, DE

Scientific Project Manager

PSM GmbH

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

1
2
3
4
5

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.

1
2
3
4
5

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.

1
2
3
4
5

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.

1
2
3
4
5

PAST

Attendee