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PDA Pharmaceutical Manufacturing & Quality Conference 2025
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PDA Pharmaceutical Manufacturing & Quality Conference 2025 will take place on 6 - 7 May 2025 in Singapore.
Target Attendees: Auditors, BioMonitoring Specialists, Biotech Managers, Head of Plant, Managing Directors, Microbiologists, Production Manager, Quality Assurance Managers, Quality Control Managers, Research and Design Specialists, Regulators, Regulatory Compliance Managers, Consultants, Technical Account Specialists, Unit Managers
Highlighted Presenters
Key Presenters
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Wenliang Chen
PTI (Packaging Technologies & Inspection)
APAC BD & Technical Service Manager
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Noba Ebaid
PTI – Packaging Technologies & Inspection
Director of Sales, Americas & Asia-Pacific
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David Keen, MRSB CBiol
Ecolab Life Sciences
Director Pharmaceutical Microbiology & Consulting
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Daniel Markl
Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC)
Associate Director
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Alan Smith, PhD
Charles River Labs
Executive Director of Operations Excellence, Biomanufacturing
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Agenda
Discover What's Happening Each Day
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SGT Standard Time (UTC +8:00)
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Registration
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Opening Session
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Opening Remarks by the Committee Chairperson
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Session 1: Regulatory and Industry Session
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New expectations: MHRA Perspective
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Expert Roundtable: Evolving Nature of Trade Policies – Their Impact on APAC Pharmaceutical Sector
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Coffee Break at the Exhibition Hall
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Session 2: New Modality/Technologies (Part 1)
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Welcome Remarks by the Moderator
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Factory of the Future - Autonomous Manufacturing
In his presentation CEO Casper Hansen, Technicon A/S will address 7 global structural challenges. Accordingly, Mr. Casper Hansen will share his view on how advanced, innovative, and thoroughly tested high-quality robotics solutions effectively are able to combat those universal barriers. Based on his expertise and by presenting technical examples Mr. Casper Hansen will demonstrate how pharma companies simultaneously can reduce the risk of contamination, free up valuable human resources and serve patients better.In his presentation CEO Casper Hansen, Technicon A/S will address 7 global structural challenges. Accordingly, Mr. Casper Hansen will share his view on how advanced, innovative, and thoroughly tested high-quality robotics solutions effectively are able to combat those universal barriers.
Based on his expertise and by presenting technical examples Mr. Casper Hansen will demonstrate how pharma companies simultaneously can reduce the risk of contamination, free up valuable human resources and serve patients better.
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Cell and Gene Therapy Scale Up: Lessons Learnt from the Semiconductor Industry
The semiconductor industry provides valuable analogies for accelerating progress in cell and gene therapy (CGT). The lessons include the adoption of innovative technologies to reduce costs and improve reproducibility and quality, such as the use of automatic facilities to maintain the quality and reduce labor cost. Further, apply new technologies such as stable cell lines for LVV and AAV manufacturing, and allogeneic cell to enhance CGT quality and productivity. As many biotech and pharmaceutical companies lack the infrastructure and expertise required for CGT development and manufacturing, contract development and manufacturing organizations (CDMOs) play a pivotal role in supporting process development and production, accelerating the advancement of CGT programs..The semiconductor industry provides valuable analogies for accelerating progress in cell and gene therapy (CGT). The lessons include the adoption of innovative technologies to reduce costs and improve reproducibility and quality, such as the use of automatic facilities to maintain the quality and reduce labor cost. Further, apply new technologies such as stable cell lines for LVV and AAV manufacturing, and allogeneic cell to enhance CGT quality and productivity. As many biotech and pharmaceutical companies lack the infrastructure and expertise required for CGT development and manufacturing, contract development and manufacturing organizations (CDMOs) play a pivotal role in supporting process development and production, accelerating the advancement of CGT programs.
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Lunch Break
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Session 3: New Modality/Technologies (Part 2)
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Operational Efficiency In Viral Vector Manufacturing Using AI or New Technologies
This presentation will describe some of the challenges and acute demands required to successfully develop high quality GMP viral vectors. The presentation will focus on not only viral vector manufacturing but also touch on timely generation of the required high quality precursors such as GMP plasmids and the use of optimized backbones and cell lines selected to enhance outcomes during vector manufacturing. The presentation will also address opportunities to use advanced technologies and machine learning to reduce cost and further optimize outcomes. -
Quality Regulatory Considerations for ADCs
Antibody-drug conjugates (ADCs) are a class of biopharmaceutical drugs designed to specifically target and kill cancer cells. Recent developments in ADC research include next-generation ADCs, bispecific ADCs, and expanding their therapeutic applications beyond oncology. Before a therapeutic product can be marketed, the drug product owner must provide preclinical and clinical data, as well as manufacturing information. Developing ADCs presents several challenges, particularly in meeting the quality requirements set by health authorities. This presentation will discuss the quality regulatory considerations for ADCs, aiming to provide drug product owners with insights into the current quality regulatory landscape for ADCs.Antibody-drug conjugates (ADCs) are a class of biopharmaceutical drugs designed to specifically target and kill cancer cells. Recent developments in ADC research include next-generation ADCs, bispecific ADCs, and expanding their therapeutic applications beyond oncology.Before a therapeutic product can be marketed, the drug product owner must provide preclinical and clinical data, as well as manufacturing information. Developing ADCs presents several challenges, particularly in meeting the quality requirements set by health authorities.This presentation will discuss the quality regulatory considerations for ADCs, aiming to provide drug product owners with insights into the current quality regulatory landscape for ADCs. -
Panel Discussion and Q&A
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Session 4: Operational Excellence in Manufacturing (Part 1)
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Welcome Remarks by the Moderator
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Continuous Improvement Culture
This presentation on Digital Enabling Manufacturing strategy represents a holistic approach taken at MSD to transforming manufacturing operations through digital technologies. By focusing on interconnected initiatives and user-centric design, the strategy aims to create a more resilient, efficient, and responsive manufacturing environment. The emphasis on data management and process optimization is expected to drive significant improvements in productivity and quality across the manufacturing network. -
Revolutionizing Process Design with GenAI: The Kindeva Approach to Manufacturing Excellence
This presentation introduces a groundbreaking GenAI-powered approach, as utilized at Kindeva's new Fill-Finish manufacturing facility. By adopting an integrative, end-to-end strategy, Kindeva leverages Generative AI to centralize and automate the design and control of manufacturing processes. A repository of hundreds of micro-process steps enables computer-generated and highly controlled outputs for process design, risk assessment, SOPs, MBRs, monitoring, and training.
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Coffee Break at the Exhibition Hall
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Session 5: Operational Excellence in Manufacturing (Part 2)
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Regulations for AI application: Do we need more?
Abstract:
- This presentation will demonstrate the global regulatory landscape for AI applications used in digitalization supporting development, manufacturing, and testing and Quality Management processes.
- It will demonstrate how existing schemes of Quality Risk Management can be used to ensure safe, trustworthy, and ethical implementation of regulatory compliant AI applications where Computerized System Validation play a major role.
Objective
- Share theoretical and practice aspects on applicable regulatory guidance for AI implementation to support ensuring compliance in inspections
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Process Modelling: A Recently Initiated Center of Excellence in Regulatory Science & Innovation(CERSI) in UK with CMAC
In recent years, Chemistry, Manufacturing, and Controls (CMC) processes have increasingly emerged on the critical path in drug development. To address this, the Digital CMC CERSI aims to unlock digital transformation benefits for accelerating drug development while reducing the environmental impact of the industry. The CERSI tackles this by establishing a forward-looking regulatory maturity framework that considers MHRA’s five key principles for regulatory use of AI to enhance confidence in digital tools. This is demonstrated through the delivery of regulatory use cases for AI and predictive models in CMC, and complemented by delivering impactful digital CMC training.In recent years, Chemistry, Manufacturing, and Controls (CMC) processes have increasingly emerged on the critical path in drug development. To address this, the Digital CMC CERSI aims to unlock digital transformation benefits for accelerating drug development while reducing the environmental impact of the industry. The CERSI tackles this by establishing a forward-looking regulatory maturity framework that considers MHRA’s five key principles for regulatory use of AI to enhance confidence in digital tools. This is demonstrated through the delivery of regulatory use cases for AI and predictive models in CMC, and complemented by delivering impactful digital CMC training.
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Panel Discussion and Q&A
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SGT Standard Time (UTC +8:00)
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Registration
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Session 6: Microbiology (Part 1)
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Welcome Remarks by the Moderator
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In-Process Controls in Pharmaceutical Production: What to Test and How to Use the Results
In-process controls form a critical part of the contamination control strategy in pharmaceutical production. Recent regulatory updates will be discussed, how to apply the requirements whilst maximising the value of the data generated.The talk will discuss some case studies relating to out of trend and out of specification results, how investigative testing and root cause analysis can remediate issues to reduce the likelihood of future failures. The talk will also cover manufacturing hold times and the information needed to support them, and how routine monitoring may support the holistic contamination control strategy.
Related Technical Reports (TR): Technical Report No.90: Contamination Control Strategy Development -
Disinfectant Field Study
A review of the final phase of implementation of a cleaning and disinfection regime; the performance qualification phase, also referred to as Phase III or in-situ field studies. The purpose of this phase is to demonstrate the effectiveness of a cleaning and disinfection regime once it is in use within the facility, through the generation of data. The presentation will outline possible structures to a Phase III program, how to handle the data generated and how to capitalise on the study to address other elements of a cleaning and disinfection regime, such as residue management and surface deterioration.A review of the final phase of implementation of a cleaning and disinfection regime; the performance qualification phase, also referred to as Phase III or in-situ field studies. The purpose of this phase is to demonstrate the effectiveness of a cleaning and disinfection regime once it is in use within the facility, through the generation of data. The presentation will outline possible structures to a Phase III program, how to handle the data generated and how to capitalise on the study to address other elements of a cleaning and disinfection regime, such as residue management and surface deterioration.
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Enzyme Indicators – The Approach to H2O2 Bio-decontamination Cycle Development, Qualification and Beyond
Enzyme Indicators (EIs) continue to be established as a rapid tool for Bio-decontamination processes within pharmaceutical manufacturing providing instant and quantitative feedback of H202 efficacy. With the updated requirements of Annex 1 specifying that bio-decontamination processes should be understood and validated, this presentation will demonstrate the EIs ability to aid, clarify and provide additional confidence of H202 bio-decontamination process in different applications including a case study with an end to end validation approach. The takeaway for the attendees of the session will be to understand more about the fundamental aspects of the technology to meet the challenges of annex 1, whilst also hearing and engaging on how the technology has been put into use not only within individual pharmaceutical companies and other industry sectors, but also collectively to ensure that the industry has a harmonized approach to the ongoing use of EIs.Enzyme Indicators (EIs) continue to be established as a rapid tool for Bio-decontamination processes within pharmaceutical manufacturing providing instant and quantitative feedback of H202 efficacy.
With the updated requirements of Annex 1 specifying that bio-decontamination processes should be understood and validated, this presentation will demonstrate the EIs ability to aid, clarify and provide additional confidence of H202 bio-decontamination process in different applications including a case study with an end to end validation approach.
The takeaway for the attendees of the session will be to understand more about the fundamental aspects of the technology to meet the challenges of annex 1, whilst also hearing and engaging on how the technology has been put into use not only within individual pharmaceutical companies and other industry sectors, but also collectively to ensure that the industry has a harmonized approach to the ongoing use of EIs.
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Coffee Break at the Exhibition Hall
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Session 7: Microbiology (Part 2)
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The Dynamics Between Microbial Ingress and Container Closure Integrity
Container Closure Integrity (CCI) is vital to ensuring the sterility and safety of parenteral pharmaceuticals. Historically, microbial ingress testing was the gold standard for evaluating CCI, linking sterility and closure integrity. However, this method is no longer considered suitable due to its probabilistic nature and lack of procedural clarity. This presentation will explore the science behind CCI, examine limitations of microbial ingress testing, and highlight modern, regulatory-aligned technologies that provide greater assurance against contamination and integrity risks. -
Low Endotoxin Recovery Challenge and PDA Technical Report 82 Revision
Since the publication of PDA TR 82 in 2019, there have been significant industry effort to understand the Low Endotoxin Recovery (LER) phenomenon and its correlation to product quality and patient safety. While TR 82 is a recognized standard by major health authorities, including the recently revised EMA Questions and Answers for Biological Medicinal Products, for the design of LER studies, there are ongoing challenges for industry to interpret and execute the required studies to support Biological License Application. This session is to review some of these challenges and the upcoming revision effort undertaken by PDA to ensure this TR will remain as a relevant resource for the industry.Related Technical Reports (TR): PDA Technical Report No.82 (TR 82) Low Endotoxin Recovery (Single user digital version)
Since the publication of PDA TR 82 in 2019, there have been significant industry effort to understand the Low Endotoxin Recovery (LER) phenomenon and its correlation to product quality and patient safety. While TR 82 is a recognized standard by major health authorities, including the recently revised EMA Questions and Answers for Biological Medicinal Products, for the design of LER studies, there are ongoing challenges for industry to interpret and execute the required studies to support Biological License Application. This session is to review some of these challenges and the upcoming revision effort undertaken by PDA to ensure this TR will remain as a relevant resource for the industry.
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Panel Discussion and Q&A
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Lunch Break
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Session 8: Annex 1 Implementation and Consideration (Part 1)
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Welcome Remarks by the Moderator
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Sterility Assurance – Meeting an Unmet Industry Technical Need on Design and Operation of RABS Systems
Related Points to Consider (PtC): Points to Consider for Restricted Access Barrier Systems - Annex 1 Implementation
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CCS From The Perspective of An ex-regulator. 2 Years Post Annex 1 Where and Why Are We Still Struggling On Implementing
Annex 1 was nearly 7 years in the drafting stages with 2 public consultations and review versions released. All versions release for public consultation and the final version release in August 2022 included reference to the Contamination Control Strategy (CCS) . Given that this requirement for the CCS has now been required for nearly 2 years this presentation seeks to understand some of the challenges of why companies are struggling to implement. The presentation will discuss items such QRM principles as applied to the CCS, required knowledge and knowledge management and senior management support.
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Coffee Break at the Exhibition Hall
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Session 9: Annex 1 Implementation and Consideration (Part 2)
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Environmental Monitoring Performance Qualification of New Facilities (EMPQ) in New Facilities: Application of Industry Harmonized Approach
This presentation will focus mainly on the challenges that companies are facing to address the new Annex 1 requirement of environmental monitoring and performance qualification. Given that the key changes in annex 1 for environmental monitoring and qualification are mainly related to non-viable particles, the presentation will provide key information to understand how the requirements have moved within the revision history of Annex 1 and ISO 14644-1 & 2. The technical aspects for cleanliness qualification and non viable monitoring will be discussed in the context of new facilities.This presentation will focus mainly on the challenges that companies are facing to address the new Annex 1 requirement of environmental monitoring and performance qualification. Given that the key changes in annex 1 for environmental monitoring and qualification are mainly related to non-viable particles, the presentation will provide key information to understand how the requirements have moved within the revision history of Annex 1 and ISO 14644-1 & 2. The technical aspects for cleanliness qualification and non viable monitoring will be discussed in the context of new facilities.
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Annex 1 Implementation Survey, CCS, ICHQ9(R1)
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Program Planning Committee
The Team Behind the Event's Agenda
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Emily Cheah, PhD
Charles River Laboratories
Senior Managing Director Singapore and APAC Technical Operations Lead
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Location and Travel
Venue Details and Accommodations
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.
Andaz Singapore, by Hyatt
Reservation Instructions
PDA recommends the reservation at the Andaz Singapore, by Hyatt.
Registration
Pricing Options
Standard Registration
Member Price
USD 1,499GovernmentMember Only
USD 499
Health AuthorityMember Only
USD 499
Early Career ProfessionalMember Only
USD 699
AcademicMember Only
USD 499
Non-Member
USD 1,899
Presenters
PDA events bring together top-notch industry experts, innovators, and practitioners who are shaping the future of pharmaceutical science and manufacturing. Our presenters are selected for their experience, insight, and commitment to elevating the global community through knowledge sharing.
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Exhibitors
Exhibitors and Innovators
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