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  Andiyanto Sutandar

  Consulting Director of NNIT Singapore Pte. Ltd

Generative AI has the potential to unleash new wave of productivity. This presentation will share with you the different patterns of AI use cases and guardrails needed to ensure adherence to the highest ethical standards, while gaining efficiencies and insights that ultimately improve patient outcomes.

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  Vincent Tan

  Director, Information Systems of Amgen

Operations must be appropriately designed, maintained, and updated to prolong their life and meet CGMP expectations. This is necessary to reliably produce drugs of appropriate quality, including safety. Quality risk management tools and the understanding of several key principles enable design, maintenance, and change. Failures to appropriately design and maintain manufacturing operations have led to serious adverse events, including harm in areas that are generally not recognized as high risk.

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  Timothy Pohlhaus

  Consumer Safety Officer, OC, CDER at US FDA

Peter will share regulatory pathways on interacting with FDA/CDER when designing a new facility or upgrading an existing facility. And the second part of the presentation will discuss regulatory expectations and common issues identified during review and inspections.

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  Peter Qiu

  External Advocacy Lead, APAC at Roche Genentech

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  Georg Roessling

  Consultant for Pharma and Suppliers

The ACES facility was named for its attributes in the acronym denoting Agile Manufacturing, Compact and Configurable, End to End, Single Use Technology, and it represents a pioneering approach to building a cGMP clinical trial manufacturing plant. The presentation shares the swift and meticulous construction process of the ACES facility at Hilleman Laboratories, completed within budget and in an unprecedented 8-month timeline, from dismantling to qualification initiation. The presentation will also introduce the multifaceted capabilities of the ACES facility, tailored to support platform-agnostic vaccine clinical trial manufacturing. Emphasis is placed on the transformative impact of agile methodologies, compact design principles, end-to-end integration, and the adoption of single-use technology on clinical manufacturing processes.

The project leveraged the collaborative efforts of the ACES team, boasting a cumulative 300+ years of experience in biopharmaceutical manufacturing, and which developed strategies for the seamless attainment of regulatory approvals while upholding rigorous compliance standards.

The significance of the ACES facility's design and construction offers insights invaluable for advancing the field of biopharmaceutical manufacturing towards heightened efficiency and innovation.

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  Sankar Dharmaraj

  Director of Hilleman Laboratories

Sankar Dharmaraj, Director, GMP Operations, Hilleman Laboratories (invited)

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  Sankar Dharmaraj

  Director of Hilleman Laboratories
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  Kai Yin Po

  Associate Principal Scientist at MSD International GmbH
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  Peter Qiu

  External Advocacy Lead, APAC at Roche Genentech
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  Wallace Torres

  VP Site Operations at Amgen Singapore Manufacturing
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  Georg Roessling

  Consultant for Pharma and Suppliers

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  Georg Roessling

  Consultant for Pharma and Suppliers

The pharmaceutical Industry relied for a long time on recommendations provided by manufacturers & suppliers of Total Particle Counters to define acceptable tubing configurations connecting the particle probe with the counter. This is also what ISO 14644-1 recommends. The new EU 2022 Annex 1 still refers to manufacturer’s recommendations to define acceptable tube diameters and bend radii, but it requires as well that your tubing must be now qualified. In this context, GSK defined a global qualification strategy and conducted several particle recovery studies. This with the primary intent to qualify the existing tubing configurations used across its manufacturing sites and to remediate potential outlier configurations when needed. During these studies, several important learnings were generated, especially around the obtained recovery rate of macroparticles of ≥ 5µm. During this presentation, we will be presenting the most important learning and contributing factors in particle loss.

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  Kurt Jaecques

  Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines

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  Meow Hoe Boon

  Deputy Director - OA of Health Sciences Authority of Singapore
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  Kurt Jaecques

  Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines
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  Jaime Kaho`ohanohano

  Microbiology Consultant at Microrite, Inc
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  Rebecca Michel

  Director, Microbiology of Tolmar
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  Peter Qiu

  External Advocacy Lead, APAC at Roche Genentech
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  Georg Roessling

  Consultant for Pharma and Suppliers

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  Emily Cheah

  Senior Managing Director of Charles River Laboratories

The United States Pharmacopeia (USP) continues the generation of contemporary standards in the field of pharmaceutical microbiology which are relevant to drug and device manufacturing and testing. These standards are recognized by global health authorities and the likes of International Council for Harmonization (ICH). The USP General Chapters Microbiology Expert Committee is responsible for sustaining >50 chapters and continues its ambitious workplan to add a significant number of new chapters on critical topics. This presentation will briefly re-introduce you to the USP standard setting process, introduce you to current priorities, and comprehensively update you on the committee’s advancement of chapters on endotoxins and pyrogens, rapid (modern) microbiological methods, bioburden contamination testing, microbial control, and sterility assurance. Several draft chapters have recently been published in the Pharmacopeial Forum, public commentary has been received and is in review. Details on this and the audacious work plans will equip with you a clear understanding of future chapters, their content and how you may contribute to these standards.

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  Edward Tidswell

  Executive Director, Microbiological Quality and Sterility Assurance of Merck

Environmental monitoring excursions necessitate thorough investigation, which should extend beyond your computer. Gemba walks are essential in an investigation and should be done on a routine basis. Inadequate investigations can lead to incorrect corrective actions and more excursions; ultimately resulting in wasted time and money for your organization. There are key components to a comprehensive EM investigation. These keys are fundamental and use science to drive to root cause and purposeful CAPAs.

Learning Objectives:
• Learn key components of a robust EM investigation
• Review case studies of inadequate investigations
• Learn the importance of a Gemba walk

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  Jaime Kaho`ohanohano

  Microbiology Consultant at Microrite, Inc

The new European Union GMP Annex 1 encourages the adoption of Rapid Microbiological Methods (RMM) to enhance detection of contamination and mitigate product risk. Alternative monitoring systems, such as Biofluorescent Particle Counters (BFPCs), offer real-time viable and total particle monitoring during operations, enabling immediate response to excursions, segregation of potentially compromised material and allowing better root cause analysis. Although RMM's in principle lack isolates for microbial identification, their implementation provides advantages in real-time monitoring, detecting stressed and viable but nonculturable (VBNC) microorganisms. A pilot project at GSK on an existing RABS filling line explores the efficacy of this BFPC technology, with initial findings promising. This presentation highlights the imperative shift towards RMM adoption for enhanced microbial monitoring in pharmaceutical manufacturing, with BFPCs demonstrating potential despite challenges in microbial identification.

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  Kurt Jaecques

  Senior Advisor, GSK Vaccines Sterility Assurance Centre of Excellence at GlaxoSmithKline Vaccines

Simplicity is vital for regulatory compliance, patient safety, efficiency and competitiveness. It is important to note that reducing complexity should extend beyond technology and process improvement to interpersonal interactions.

A lack of openness could breed distrust between regulators and companies, hinder collaboration among professionals, and make straightforward matters more complicated to resolve. In contrast, open communication fosters trust. It creates a conducive atmosphere for teamwork, creativity, innovation, and effective problem-solving.

In this presentation, we will delve into factors hindering openness and offer suggestions to enhance it in the workplace.

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  Kai Yee Loo

  Director of Teambiosis

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  Mark Chua

  Principal Research Engineer II Manufacturing Control Tower at Singapore Institute of Manufacturing Technology, Agency for Science, Technology and Research (A*STAR)
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  Kai Yee Loo

  Director of Teambiosis
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  Pao Chun Lin

  QC (ASAT) Manager at GSK

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  Wayne Lee

  Fast Trak™ Validation Services Leader, Global at CYTIVA

The US FDA has been a leading regulator in implementing and advocating for use of ICH Q12. The Agency has also expanded the focus on QMM as a solution for numerous activities relying on pharmaceutical PQS, including supply chain resilience and ICH Q12. This discussion will highlight some of the FDA’s explicit connections between ICH Q12 and QMM. Emerging concepts related to the nexus between these two important initiatives will be explored. Future considerations for success related to both ICH Q12 and QMM will be presented.

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  Bruce Loxley

  Senior GMP Compliance Advisor at GSK
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  Ben Stevens

  Director, CMC Policy and Advocacy of GSK