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  Rama Tummala

  Principal Quality Audit Manager at GSK

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  Rick Friedman (Virtual)

  Deputy Director of US Food and Drug Administration

The rapid evolution of mRNA vaccines as a result of the Covid pandemic has accelerated further utilization of mRNA technology as a modality for vaccines. The following presentation discusses Moderna’s challenges and opportunities in establishing a platform process. Scale-up considerations also become a challenge when establishing a platform. Variations to the platform, though necessary, take careful consideration to allow full utilization of the established platform.

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  Aaron Allen

  Director, Global Quality External Engagement of Moderna

The session will dive into FDA inspection and enforcement actions for the year 2022, specifically highlighting trends and areas of focus. The session will continue to build on the recent trends with the recent policy advancements in the areas of mutual recognition, user fees act updates, and biosimilars.

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  Jay Jariwala

  Senior Director, Regulatory Compliance of Sidley Austin
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  Manoj Bhargava

  Partner, Capital Markets at Sidley Austin

Jay Jariwala and Manoj Bhargava, Sidley Austin LLP

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  Aaron Allen

  Director, Global Quality External Engagement of Moderna
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  Manoj Bhargava

  Partner, Capital Markets at Sidley Austin
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  ShiMing Chau

  Quality Director of Janssen Pharmaceuticals
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  Huixing Feng

  Senior Technical Expert APAC, BioReliance® Contract Testing Services at Merck KGaA
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  Jay Jariwala

  Senior Director, Regulatory Compliance of Sidley Austin
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  Dr. Priyabrata Pattnaik

  Deputy Managing Director of Indian Immunologicals limited

As part of the new revision of Annex 1 “Manufacture of Sterile Medicinal Products”, which will become effective on 24 August 2023, the process for manufacturing facilities getting ready for the change, challenges to align with new requirements and the value of a robust contamination control strategy will be discussed.

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  Mairym Williams

  Director Quality Assurance of Amgen Singapore Site Operations

The exponential growth of technology, especially in the areas of Artificial Intelligence (AI) and automation, have changed the way we think and operate. Highly regulated industries such as pharmaceutical industry is not exempted. We are being challenged to speed up the Research & Development (R&D), and supply of new and existing medicinal products through the adoption of AI and automation. The fast rate of change has also added pressure to current workforce to adapt to new technologies quicker, and to shorten the time to competence. One of our bold aspirations is to apply standardization to the human factor accordingly to parallel advances on the equipment and processing side. Recognizing that the human workforce will remain its individual character, we try anyway to standardize the human workforce by generic and quantifiable patterns. To do so we utilize VR technology, not only to overcome the constraints of equipment availability for training, but to achieve long lasting knowledge retention and behavioural change through the combination of knowledge of human psychology and VR technology to allow visualizing the invisible. Behaviour patterns, particularly in aseptic processing, are divided and categorized in “key moments”. Operators are getting trained and refreshed on these “key moments” proactively using VR technology. The deployment of VR technology as one of the training methods to qualify operators in Good Manufacturing Practice (GMP) environment, requires more actions as compared to VR offerings in gaming and entertainment industries. Two (2) critical elements are system validation to fulfil regulatory requirements, and connectivity to Learning Management System (LMS) to manage training activities efficiently with proper documentation. Compliance analysis is a must, and it is the starting point to assess the risk based on the intended use of the VR system, GxP applicability, and regulatory considerations associated with the business processes. Output from compliance analysis drives the formation of Compliance Plan that governs the overall validation effort.

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  Dieter Bachmann

  Director, Aseptic Manufacturing of Johnson & Johnson MQ&SA
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  Molly Ting

  Director of Johnson & Johnson International (Singapore) Pte Ltd

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  Richard Chai

  Technical Service Manager at STERIS Life Sciences

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  Ziva Abraham

  CEO of Microrite
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  Dieter Bachmann

  Director, Aseptic Manufacturing of Johnson & Johnson MQ&SA
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  Richard Chai

  Technical Service Manager at STERIS Life Sciences
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  Richard Denk

  Senior Consultant Aseptic Processing & Containment at Skan AG
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  Andiyanto Sutandar

  Consulting Director of NNIT Singapore
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  Molly Ting

  Director of Johnson & Johnson International (Singapore) Pte Ltd
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  Mairym Williams

  Director Quality Assurance of Amgen Singapore Site Operations

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  Emily Cheah

  Senior Managing Director of Charles River Laboratories

Quality and Microbiology personnel often struggle with finding root causes of contamination events, and assessing risk of contaminants on product and patient is a daunting task. To conduct a fruitful investigation, one must start with the understanding that the contaminant well followed by mapping out the ingress and transport path and ensure that the contamination is not proliferating within the clean environment or product. Exploring solutions on how to prevent recurring instances is key to the remedial process. Finally, the impact of the contaminants on the product should be assessed and this cannot be done unless the contaminant is well understood. Learn investigative processes never discussed before to help implement effective corrective and remedial actions.

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  Ziva Abraham

  CEO of Microrite

You have all the pieces, now let’s put the CCS puzzle together! The task of writing a Contamination Control Strategy (CCS) can be overwhelming, but it is less difficult when you have a plan and the right tools to guide your way. This presentation will offer practical insights into effectively implementing and sustaining a contamination control strategy aligned with EU Annex 1 requirements for sterile medicinal products.

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  Kim Sobien

  Senior Consultant - Microbiology at Valsource

In pharmaceutical microbiology labs, bioburden results are traditionally counted visually and documented by analysts and it is usually aided with colony counter and pen. With the implementation of automated colony counting systems, the technology is seen to enhance the data integrity controls for the assays, reduce the result inaccuracy arises from human error and improve the overall testing efficiency. The sharing is to describe the steps and considerations taken during the evaluation and implementation of the alternative and rapid microbiogical method in Roche.

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  Yen Tong Chan

  QC Team Leader at Roche

The revision of Annex 1 encourages the use of new and alternative technologies that meet or exceed the requirements of Annex 1 and follow the principles of QRM. Enzymatic indicators (EIs) as an alternative to biological Indicators (BIs) have been under development for some 􀆟me and now there are breakthroughs that support the introduction of EIs to improve cycle development efficiencies when developing vH2O2/ VHP bio-decontamination cycles for barrier technology and associated GMP applications (Rooms and Material transfer devices). This presentation will focus on how efficiency improvements can be achieved and the relationship of EIs and BIs in cycle qualification, re-qualification and process monitoring.

The differences and attributes of EIs and BIs and understanding inherent variabilities that need managing in cycle development and qualification studies.
• Bio-decontamination vH2O2/VHP cycle methodology using a combination of BIs and EIs to improve cycle development efficiency (time reduction and improved knowledge on efficacy profile across challenge locations.
• Case study: Filling line for Viral vectors and application of EIs and BIs in cycle development: challenges and benefits.
• Summary and reflection on the future following Annex 1 implementation.

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  James Drinkwater

  Head of GMP Compliance and Aseptic Processing Support at Franz Ziel

In this session, AWS will brief their life sciences solutions focused on Automated Quality Control, Real time condition monitoring and Digital Twins. This will be explained by how Merck reduced the overall false reject rates in their drug product automatic visual inspection process; how Aizon improves pharma manufacturing with AI; how Moderna delivers mRNA drugs faster and how Multiply labs uses AWS Robomaker to manufacture individualized medicines.

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  Anil Yadav

  Global Account Manager, Industrial at Amazon Web Services

In this session, we will cover the practical implementation of digital technologies in Thermo Fisher Scientific's Pharma Services Group (PSG) global network and Singapore site. The session aims to showcase how various systems' interfaces have resulted in improvements in productivity and quality through the adoption of the digital technologies and advanced analytics. Additionally, we will discuss the use of Augmented Execution System (AES) for training purposes within the company, providing insights into how these innovations contribute to skill development and operational efficiency. Join us to gain valuable insights into the transformative potential of digital applications in the realm of PSG manufacturing.

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  Selva G

  General Manager - Pharma Services Group (PSG) at Thermo Fisher Biopharma Services Pte Ltd, Singapore

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  Hue Kwon

  Head of Quality at Samsung Bioepis

Despite the growing demand for drug product manufacturing, the biopharmaceutical drug product manufacturing sector encounters various challenges in technology transfer, production, and regulatory filings. Specifically, the industry has recognized an trend of increased challenges in sterile drug manufacturing. The following examples illustrate these challenges:
• Non-terminal sterile processes may contain components that cannot be effectively sterilized by filtration, posing difficulties in implementing sterile processes.
• The continuous increase in high-concentration formulation products presents challenges in manufacturing processes and highlights the need for process adaptability and stability.
• Probabilistic detection in visual inspection poses challenges in visible foreign particle control, requiring the development of sensitive detection methods and robust control measures.

Addressing these challenges is crucial for advancing the field of biopharmaceutical drug product manufacturing and ensuring the production of high-quality, safe, and reliable sterile products through outsourcing.

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  Yang Si

  Head of Drug Product Manufacturing at Wuxi Biologics

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  Rama Tummala

  Principal Quality Audit Manager at GSK
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  Emily Cheah

  Senior Managing Director of Charles River Laboratories