• 

  Sooho Lee

  Quality Assurance and Commercial Lead, Janssen Vaccines

No-Touch-Transfer (NTT) has become established as a GMP and QRM compliant alternative methodology to introduce pre-sterilized RTU containers into aseptic filling environments. This alternative approach does not rely on disinfection steps applied on outer packaging layers. It is based on multi-layered packaging, sterility maintained through the supply chain and a process design of material transfers through changing GMP grades. In this process, the contents from the secondary bag packaging is ejected without direct contact or exposure to a lower grade of environmental control than the zone the material is entering into. With this methodology there is no need for in-process material disinfection steps like vaporized hydrogen peroxide or e-beam. The system design requirements and qualification approaches for this methodology will be presented to provide practical guidance for application with respect to contamination control zones and airflow characterization.

• 

  Dr Holger Kranenburg

  Senior Scientist, GMP Compliance, Franz Ziel GmbH

To keep up with injectable market evolution, pharmaceutical companies and CDMOs need to be able to manage a wide range of toxic/biological risks in different products and packaging types. When an injectable product includes highly biologically active components with e.g. viral vectors, the production process and the entire facility may have to comply with BSL-2 or even BSL-3 requirements, the increasing the complexity of equipment and processes tends to limit production flexibility. At the same time, any high-potent components, such as antiblastic products or monoclonal antibodies linked to cytotoxic components (ADC), may require the entire fill-finish system to qualify up to OEB level > 5, i.e. with release of contaminants outside the isolated environment in amounts lower than 1 µg/m3.

The presentation intends to demonstrate, through a case study, how it is possible to create innovative aseptic isolated production lines able to achieve this goal, using isolator with “full one-pass” ventilation approach. This solution makes possible to treat highly toxic products or products with a high biological risk, minimising the risk of cross-contamination in the ventilation and filtration system. The one-pass design required the creation of innovative balancing chambers and pressure control systems, capable of handling air flow rates three times higher than traditional isolators, while maintaining high pressure, temperature and humidity control requirements.

Thanks to the one-pass design, it is also possible to reduce the duration of tradition decontamination cycles even if a very low hydrogen peroxide residue (less than 0.2 PPM) is requested. A series of studies were carried out for the optimization of the decontamination cycles with spectrometric instruments for analysing the concentration of hydrogen peroxide up to residues of 100 ppb, to avoid any risk towards easily oxidizable products.

Finally, it is analysed the inlet and outlet filter configuration, wash-in-place automatic systems and how the same isolated line can switch from hazardous to non-hazardous products, leveraging the pressure cascade flexibility between the isolator chambers.

• 

  Marco Preus

  Aseptic Processing Solutions, Sales Director for the APAC area, IMA S.P.A. - IMA Life division

This presentation will focus on innovations in the manufacturing of parenteral packaging components to address the demanding needs for packaging sensitive drugs such as biologics.
The agenda of presentation will include.
• Common concerns in the pharmaceutical industry surrounding parenteral packaging
• Advancements in products and processed to achieve best-in-class specifications, with a focus on ‘zero-defects’
• A quality by design approach for manufacturing components to mitigate industry concerns that relate to particulate and silicon contamination

• 

  Ashwini Bhisikar

  Technical Key Account Manager, Datwyler Pharma Packaging

We will start with a short introduction about Datwyler and Datwyler’s offerings, and follow with videos to show our products and how we help to improve patients’ lives with our products and services

• 

  Cathy Joa

  Key Account Manager Korea, Datwyler

The EU GMP Annex 1 revision provides more comprehensive requirement from the regulatory with significant improvement over the current version. This session will focus on overall training program covering from training, Aseptic Process Simulation (APS) and qualification of the aseptic operators to meet the requirement from EU GMP Annex 1 revision. The session will share the aseptic operator training program improvements made at Janssen utilizing mock RABS. The operators trained with mock RABS are qualified through aseptic process simulation by demonstrating adequacy of aseptic behavior and interventions. The session will cover the training program as well as the qualification program. In addition, current QA oversight program and oversight personnel training program at Janssen will also be shared.

• 

  Sooho Lee

  Quality Assurance and Commercial Lead, Janssen Vaccines

The dynamics of the industrial revolutions are growing continuously and are more and more noticeable. Industry X.Y leads us through constant transformations unstoppably in all areas of life into new structures and new life forms. Opportunities and possibilities open up, risks get mitigated. Structures known today and regarded as set are changing due to new operational processes, changed work areas, robotics, automation, as well as expanding and far-reaching to complete digitalization.

What does this mean for the life science industry? Are these new technologies even applicable for vaccine productions? Questions like these will be addressed in this lecture. Hereto case studies are presented where the aspects show the technical evolution so far. But not only the state of the art is addressed, as well the view into the next generation of solutions is touched. And last but not least controversial topics are covered for transparent views.

• 

  Martin Düblin

  Managing Director, One One Eleven GmbH

For many years, the pharmaceutical industry has been moving towards a connected world. When connecting the complex Bausch+Ströbel filling lines to higher-level systems, a lot of energy needs to be devoted to the identification and connection of the relevant sets of data, the creation of the logical structures and the addition of contextual information. Furthermore, an intelligent evaluation and analysis of the runtime data requires a significant amount of time and effort. With the OMNIA platform Bausch+Ströbel has developed a solution that provides a ready-to-use integration and value-added services already on the day of delivery. The applications can span from GMP and process monitoring, to automatic troubleshooting support or advanced efficiency and maintenance evaluations. All these use cases are centralized in one place – the Bausch+Ströbel OMNIA platform.

• 

  Tobias Wetzel

  Area Sales Manager, Sales Department, Bausch-Stroebel
• 

  Steffan Auwärter

  Regional Sales and Business Development Director Asia, Bausch-Ströbel

Through this presentation, Mr Jang DongChoul will lay out from Siemens' perspective what challenges the pharmaceutical and life sciences industries are currently undergoing and what digital technologies should be embraced to solve the latest challenges.

Due to new diseases and new drugs, the need for innovation and transformation is emerging in the field of research and development and manufacturing. Attendees will learn how the pharmaceutical industry has used digital technology and IT/OT convergence to adapt and accommodate these new requirements, as well as how it is driving future manufacturing environments and where the pharmaceutical industry is headed.

• 

  DongChoul Jang

  Director, Siemens Ltd Seoul

Jack Gill will co-present remotely with his PDA revision team co-chair Carol Flynn on TR43 updates. The presentation will focus on changes in this routine revision process that were implemented in 2022. A team of representatives from the Pharma Industry as well as primary container manufacturers spent 2 years reviewing the alignment of the document with current thinking on the criticality of defects, applicability of defects by container type, and suggested proactive approaches to reduce these defects through continuous improvement activities. The process began with the goal of reducing potential for patient or user injuries, loss of manufacturing efficiency and line clearances, and product recalls and worked through how to tie that into a continuous improvement program.

• 

  Carol Rea Flynn (Virtual)

  Glass Converting Quality Manager, LST, Corning Pharmaceutical Technologies
• 

  Jack Gill (Virtual)

  Senior Manager, Supplier Quality, Pfizer

In general terms, a prefilled syringe is preferred if ease of use or patient experience are more important than speed or when minimizing product waste is important. As product wastage, there is an indisputable advantage to use syringes, thanks to low overfill needed and accurate dose delivery, especially in some therapeutics areas. The high necessity for drug savings - driven by Covid-19 pandemic for example - coupled with the new wave of high-value biologics with extremely high production costs, every optimization strategy must be explored.

This presentation intends to show the impact of the internal shape of the glass cone on the dead volume, the main contributions from both the glass container and plunger stopper, as well as the strategy to mitigate the risk of drug loss and next development steps.

• 

  Enrico Barichello

  Product Manager, Stevanato Group

The Ministry of Food and Drug Safety (MFDS) is evaluating the quality, safety and effectiveness of vaccines in life cycle from the pre-clinical stage to post-marketing stage. This process is stipulated in detail in accordance with a series of legal systems from the highest law, the Pharmaceutical Affairs Act to the guidelines. In this presentation, under the theme of ‘Frameworks for vaccine regulation in Korea’, the following three things will be presented: (1) Introduction of MFDS and vaccine authorization process in Korea, (2) the current status of vaccines development & approval in Korea and the activities of the MFDS, and (3) the role of the MFDS as a regulatory body for the past three years in relation to the COVID-19 pandemic.

• 

  In-sook Park

  Head of Biopharmaceuticals and Herbal Medicine Evaluation Department, Ministry of Food and Drug Safety

Approval of a Biologics License Application is based on an integrated assessment of the product and facilities and upon determination that the product and facilities comply with the standards established in the application and the Good Manufacturing Practice requirements. This presentation will introduce FDA’s regulatory requirements for Biologics License Applications and the CGMP requirements for biotech manufacturing.
This presentation will cover the following topics:

1. Relevant Laws, Regulations, and Guidance for Biologics License Applications,
2. Regulatory requirements for Biologics license applications,
3. The integrated BLA review and inspection program, and
4. A risk- and system- based Pre-License Inspection program of manufacturing facilities.

• 

  Zhihao Peter Qiu

  External Advocacy Lead China, Global Quality and Compliance, Roche Genentech

• 

  Feng Huixing

  Field Technology Manager, Merck KGaA

• 

  Ivy Louis

  Director, Vienni Training and Consulting LLP
• 

  Hue Kwon

  Vice President and Quality Team Leader, Samsung Bioepis

Aseptic technique is a way to prevent viable microbial contamination during manufacturing of a sterile product. Injectable vaccines have to be manufactured by a stringent aseptic process. This may also be extended for intranasal and oral vaccines. Various ways are used during bulk production which may include 0.1 micron filtration for media and buffer preparation, test for bioburden at various stages and testing for sterility. Blending, filling and lyophilization form a part of filling operations. Aseptic handlings starts with class grades for manufacturing area where aseptic operations are done in Class A with class B background. Gowning qualifications of individuals are strictly followed for Classified areas. Area is monitored by Environmental Monitoring activity. For filling operation RABS ( Restricted Access Barrier System) can be utilized in fill-finish area. Stringency in filling is very vital because there is no fall back mechanism besides rejection of the product.

• 

  Ashish Sahai (Virtual)

  Director, Viral Vaccine Production, Serum Institute of India Pvt. Ltd.

Recent advancements in bioprocessing have supported the accelerated growth of the biopharmaceutical industry. With the advent of continuous biomanufacturing safety of biologics products continues to be accomplished by a multi-tiered approach involving safety testing measures throughout the development and manufacturing process. The safety program starts with raw material control and involves in-process and bulk lot release tests and evaluation of the manufacturing process to inactivate or remove viruses.
Recent advances in technologies have enabled more effective and directed end point analysis for such studies. These include methods such as nucleic acid testing, automated analyses, marker analysis, genome assessment and updated approaches to viral clearance. The key controls required to perform such testing are critical and qualification of such test to provide suitable results are necessary.

This presentation will provide specific examples of study design, technology advances and regulatory expectation while performing such safety studies.

• 

  Dr. Alison Armstrong (Virtual)

  Senior Director and Global Head of the Technical and Scientific Solutions, Merck
• 

  Feng Huixing

  Field Technology Manager, Merck KGaA

• 

  Ivy Louis

  Director, Vienni Training and Consulting LLP
• 

  Hue Kwon

  Vice President and Quality Team Leader, Samsung Bioepis
• 

  Dharti Pancholi

  Executive Vice President and Global Managing Director, PharmEng Technology
• 

  Ashish Sahai (Virtual)

  Director, Viral Vaccine Production, Serum Institute of India Pvt. Ltd.
• 

  Dr. Alison Armstrong (Virtual)

  Senior Director and Global Head of the Technical and Scientific Solutions, Merck
• 

  Feng Huixing

  Field Technology Manager, Merck KGaA
• 

  Juliana Gutierrez

  Scientific Affairs Manager ASPAC, Industrial Microbiology, bioMerieux