• 

  James Agalloco

  President at Agalloco & Associates

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  James Agalloco

  President at Agalloco & Associates
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  Brooke Higgins

  Branch Chief, CDER Office of Compliance / Office of Manufacturing Quality at US FDA
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  Hue Kwon

  Member, RAQAB at Parenteral Drug Association

A phase appropriate process validation program for visible defects should begin during process and product development and evolve with changes to the manufacturing process, product and/or container closure system, and the types of visible defects found in clinical and production batches. This presentation will summarize some of the regulatory expectations for visible defect prevention and evaluation during product development. A case study will be presented on the challenges of visible particulate control and inspection during clinical development of a difficult to inspect biological product

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  Steve Langille

  Senior Microbiology Consultant at Valsource

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  Won Min Kim

  Assistant Manager, Bio-Process Team at GC Biopharma
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  Steve Langille

  Senior Microbiology Consultant at Valsource
• 

  Hue Kwon

  Member, RAQAB at Parenteral Drug Association

This presentation outlines a journey of enhancing the existing Restricted Access Barrier System (RABS) design and procedures to meet the stringent expectations of the FDA. 

We will discuss the modifications made to the RABS design after a comprehensive risk assessment, focusing on critical areas identified by the FDA for improvement.

This includes installation of mechanical arms, introduction of supplementary tools and modification of existing filling components, those aimed at eliminating human ingress.

Additionally, we will delve into the refinement of RABS setup procedures to assure both product sterility and operation efficiency.

This involves applying multiple sterile packages for the materials which are transferred into the RABS, removing open-door intervention during the filling , and also comprehensive training programs to ensure compliance and consistency.

Through this presentation, attendees will gain insights into the challenges faced in aligning existing RABS with FDA regulatory standards and the strategies employed to achieve approval. We hope our experience serves as a useful case study for those who are navigating similar compliance hurdles in sterile product manufacturing in pharmaceutical industry.

• 

  Taehoon Kim

  Manufacturing Process Specialist in Operations at Johnson & Johnson
• 

  Jaehee Kim

  Engineer in Manufacturing Science and Technology at Johnson & Johnson

• 

  Sebastian Scheler

  Managing Director of Innerspace GmbH
• 

  Taehoon Kim

  Manufacturing Process Specialist in Operations at Johnson & Johnson
• 

  Jaehee Kim

  Engineer in Manufacturing Science and Technology at Johnson & Johnson
• 

  Seung Hwan Oh

  Site Quality Head at Johnson & Johnson

In this presentation, industry approaches when implementing contamination control strategy based on EU Annex 1 requirements will be discussed. This presentation will also provide regulatory expectations on assessing CCS during CMC review and inspections.

• 

  Wendy Tan

  Senior Consultant - Microbiology at ValSource, Inc.

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  Ditte Kivsmose Kaldor

  Quality Director, PS Aseptic Manufacturing QA of Novo Nordisk
• 

  Javier Camposano

  Vice President of Drug Product Operations at Samsung Biologics
• 

  Wendy Tan

  Senior Consultant - Microbiology at ValSource, Inc.

Welcome Remarks by the Moderator

• 

  Emily Cheah

  Senior Managing Director of Charles River Laboratories

Key Take-aways:
- Share the background and technology of rapid microbiology system (Growth direct)
- Challenge during validation

Synopsis:
Background of Rapid microbiology system introduction (Growth direct)
What is the system about and technology?
What’s the challenge?
Consideration of validation

• 

  Sunhye Hwang

  Senior Scientist, Microbiology Team at Samsung Biologics
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  Seulgi Kim

  Team Leader of QC Microbiology at Samsung Biologics

This presentation aims to provide a comprehensive overview of the elements of Environmental Monitoring Performance Qualification (EMPQ) for new facilities, based on industry led guidance. It will detail key EMPQ elements, such as prerequisites, setting alert levels/action limits, sampling requirements, and acceptance criteria. Additionally, the presentation will showcase case studies to illustrate how these concepts can be applied in practice and to share lessons learned based on EMPQ execution following the harmonized guidance. The objective is to equip attendees with the knowledge to effectively plan and execute EMPQ, ensuring cleanroom environments meet stringent quality standards.

• 

  Hilary Chan

  Global Sterility Assurance and Microbiology Lead at Takeda

The majority of biologics processing steps provide an environment that can sustain microbial growth. To ensure patient safety, control of microbial contamination is critical in biologics manufacturing process. Microbial contamination control can be achieved from 1) cleaning of purification systems, including resin, membrane, column and skid; 2) cleaning of other surfaces; 3) adequate environmental monitoring program and actions should microbial excursions occur. Lack of validation of these aspects can result in Observations during on-site inspections.

• 

  Juhong Liu

  President at GlobalSubmissions Consulting, LLC

This presentation aims to share a case study that serves as a valuable example of the new framework for enhanced data integrity and data governance. The presentation will discuss the results and lessons learned from a comprehensive one-year data vulnerability assessment conducted at a manufacturing site that relies heavily on manual batch records. The assessment took place at a large molecule site located in Incheon Songdo, where the majority of the facilities consist of standalone manufacturing equipment. Due to the complex and intricate hybrid data flows within the GxP systems and procedures, evaluating data vulnerability and implementing technical data control presented significant challenges in terms of feasibility and prioritization. Nonetheless, an action plan was ultimately devised, taking into consideration unique factors, areas for improvement, and the future assessment of additional Quality Control (QC) equipment.

In line with this initiative, KNEAT Digital Validation System was introduced as a proactive measure to eliminate the inherent data vulnerability associated with hybrid documentation in the process of QC Analytical Instrument Qualification. This innovative solution streamlines the entire process through transition onto a robust digital platform, from devising URS and protocols to the execution of test items, creation of deviation reports, and eventually the QA approval of the complete qualification package to be completed online. Our presentation showcases how data integrity and governance can be significantly enhanced by utilizing this system, as it provides a full audit trail of documentations and a comprehensive traceability matrix, ensuring transparency and accountability of the qualification data.

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  Haneul Jie

  Subject Matter Expert of Lab Equipment Lifecycle Management at Johnson & Johnson
• 

  Hannah Lee

  Site Process Owner Of Data Integrity at Johnson and Johnson

In this presentation, we introduce our most recent development – a versatile, reusable, and connected electromechanical solution that upholds the concept of drug agnosticism, platform flexibility, patient ease-of-use, as well as device programmability. By leveraging technological application expertise, we demonstrate how an electromechanical, versatile device platform can flexibly host different primary containers and formulations. Here, we also demonstrate how adding programmable firmware into the device circumvents formulation uncertainties across the pre-clinical, clinical, and commercial development of the drug counterpart. Finally, we show how the conserved element of the device results into an autoinjector solution that flexibly addresses various primary containers, therapy areas, regional healthcare landscapes, as well as patient groups. We also discuss an optional function for tracking injection-related data, opening pathways to gather detailed insights into the patient experience, and ultimately opening possibilities to connect such device usage data with other digital health solutions.

• 

  Nagisa Kobashi

  Product Manager of Global Emerging Technologies and Digital Health at SHL MEDICAL

This presentation describes practical Data Governance measures to enable data integrity assurance. Through real-world examples, participants will gain insight into the application of data governance principles across organizational cultures, manual processes, computerized systems, and complex, hybrid environments in support of effective risk-based data integrity control strategies.

• 

  Kir Henrici

  Chief Executive Officer at The Henrici Group

• 

  Kir Henrici

  Chief Executive Officer at The Henrici Group
• 

  Hannah Lee

  Site Process Owner Of Data Integrity at Johnson and Johnson
• 

  Michael de la Torre

  CEO of Redica Systems
• 

  Niraj Mehta

  Executive Director and Global Quality Lead, Strategic Programs and Regulatory Intelligence of MSD
• 

  Haneul Jie

  Subject Matter Expert of Lab Equipment Lifecycle Management at Johnson & Johnson
• 

  Javier Camposano

  Vice President of Drug Product Operations at Samsung Biologics

Welcome Remarks by the Moderator

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  Paolo Golfetto

  Director of Business Development, Drug Delivery Systems at Stevanato Group

The paper will describe best practice approaches and processes for the design transfer of injectable combination products including autoinjectors and on body delivery systems. It will draw on a number of real-life case studies and will cover aspects such as:
• Guidance on the development of drug delivery systems in ways which ensure robust understanding of performance and sensitivities, to inform effective design transfer
• Development and qualification of bespoke test jigs and fixtures for semi-automated testing of combination products, including where combined assembly and test rigs formed part of pilot production systems
• Design transfer activities to support implementation of commercial manufacturing systems, including communication of critical to quality attributes and agreement on production control strategy and component quality specifications
• Examples of risks and challenges that can arise during industrialisation and design transfer programmes, and ways to mitigate and address them. These include:
o agreement on manufacturing controls – methods and acceptance criteria
o data analysis with specific thoughts on the application of statistical approaches to demonstrate high reliability (e.g. to meet FDA ‘five nines’ guidance reliability for emergency use autoinjectors)
o handling of out of specification results, for example for activation force

• 

  Chris Hurlstone

  Director of Drug Delivery at Team Consulting

• 

  Hue Kwon

  Member, RAQAB at Parenteral Drug Association