As a hub of choice at the heart of Asia, Singapore has seen biopharmaceutical companies set up and grow their manufacturing, R&D and commercial activities here to serve patients in the growing Asian market as well as across the world. This presentation will provide an overview of Singapore’s biopharmaceutical industry and highlight the ways in which are future-proofing the local ecosystem, with a focus on talent development, innovation, supplier diversification, sustainability and provision of flexible infrastructure options.

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  Chee How Lee

  Assistant Vice President at Economic Development Board

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  Dinesh Khokal

  Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore

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  Rick Friedman

  Deputy Director, Office of Manufacturing Quality at US FDA

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  Peter Baker

  President at Live Oak Quality Assurance LLC
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  Rick Friedman

  Deputy Director, Office of Manufacturing Quality at US FDA
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  Dinesh Khokal

  Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore
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  Wallace Torres

  VP Site Operations at Amgen Singapore Manufacturing

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  Edmund Ang

  Senior Technical Expert, Asia Pacific, BioReliance® Biosafety Testing Services, at Merck Group

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  Rama Tummala

  Q&C Audit Manager, Global Quality Audit & Compliance at GSK

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  Meow Hoe Boon

  Deputy Director cum Senior GMP Auditor, Audit & Licensing Division of Health and Sciences Authority
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  Matthew Davis

  Inspections Team Lead - Senior Inspector, Manufacturing Quality Branch at Therapeutic Goods Administration (TGA) - Australian Government
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  Rama Tummala

  Q&C Audit Manager, Global Quality Audit & Compliance at GSK
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  Dinesh Khokal

  Director and Regional Lead, External Affairs, JAPAC of Amgen Biotechnology Singapore

Recent advancements in bioprocessing have supported the accelerated growth of the biopharmaceutical industry. The ability to use alternate technologies to mitigate viral risk has been central to the expedited regulatory approval for biotechnological products. With the advent of an update to the ICHQ5A(R2) regulation, although the overarching strategy of risk mitigation has not been modified, this regulation now encompasses increased recommendation for a wider selection of medicinal products and brings to the fore current scientific and industry approaches for viral clearance, continuous biomanufacturing and updated technologies to support biosafety testing. The use of molecular technologies which are shown to be comparable to classical methods have been at the forefront of such technology advances. As many of the current cell substrate and viral safety guidance provide flexibility to use alternative approaches with broad virus detection capabilities which are deemed “fit-for-purpose”. This presentation will provide supporting data for the updated recommendations in ICHQ5A(R2) and will provide practical applications as an orthogonal approach to viral pathogen risk mitigation that continues to meet regulatory expectations

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  Dr. Alison Armstrong

  Senior Director and Global Head of the Technical and Scientific Solutions at Merck

Biologic facility projects are not only technically complex but also complicated due to the interfaces with the many parties involved in the process. It is important to ensure a process risk assessment (PRA) is developed early in the project with all relevant stakeholder’s involvement, whether for green-field or brown-field construction, or even for existing facilities wanting to transition to GMP operations.

The PRA will provide the necessary information to implement the project and to accurately specify the design to ensure microbial control via conducting appropriate facility qualification and process validation activities. The complexities of contamination control of cell & gene therapy facilities together with the requirements for sterile/aseptic manufacture should not be underestimated during the facility design.

This presentation will draw on the speakers’ real-life experiences and case studies, and risks that have been mitigated early on in the design phase to ensure microbial control.

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  Michelle Peake

  Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd
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  Jo Sherriff

  Senior Consultant at Seerpharma

Pharmaceutical manufacturing quality data and processes have always required a high level of validation and oversight to ensure GMP compliance. However, while the continued use of manual, fragmented, or paper-based systems can only increase the risk of data variance and regulatory errors, the impact on operational efficiency, product quality, and supply chain continuity can actually be even more impactful on an organisation and their patients.


During this session, attendees will gain insights into:
· Why an evolution away from paperless systems is now a quality manufacturing imperative
· How quality management can directly impact manufacturing KPIs and business outcomes
· How digital innovation has simplified the transition to an agile and effective paperless QMS

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  Santhosh Francis

  Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company

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  Robert Lutskus

  Director, Informatics Operations, of Lonza
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  Andiyanto Sutandar

  Manager at NNIT Singapore
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  Santhosh Francis

  Area Vice President, South Asia and ANZ at Sparta Systems, a Honeywell Company

Microbiologists are no longer hired to simply perform QC analyses as part of their routine daily work. When something inevitably goes wrong, it is up to your microbiologists to leave the lab and scour the facility, processes, and personnel to try and piece together potential source(s) of contamination. This presentation will cover some of the major points found in the recently published Technical Report #88 to help these investigatory microbiologists build a better strategy when hunting down elusive root causes!

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  Marc Glogovsky

  Business Unit Manager, Microbiology Consulting at ValSource, Inc.

This presentation focuses on the pending changes in Annex 1 as they relate to environmental monitoring as part of a firm’s overall contamination control strategy. There is increased emphasis on utilization of risk assessments and QRM principles for environmental and personnel monitoring. The revised Annex 1 provides details about establishing routine trending of EM data as well as appropriately set alert levels and action limits. A detailed risk-based EM program should provide comprehensive feedback regarding the efficacy of a firms’ contamination control program.

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  Marc Glogovsky

  Business Unit Manager, Microbiology Consulting at ValSource, Inc.

As one of the world’s largest vaccines company, GSK unites Science, Technology and Talent to get ahead of disease together, and develops transformational vaccines and medicine that makes life better for millions of people around the world. Quality is at the heart of everything we do. Through the introduction of automation technologies in the Quality Control Unit, we aim to achieve raw data acquisition with high efficiencies, streamline processes and minimize human errors.

As part of the plan for global site harmonization, my colleague previously shared about the ‘Evaluation and Implementation Process of Automation in GSK Vaccine QC department for our Endotoxin Testing’ in the PDA_USA conference. In this presentation, we will focus on the implementation process of the automated technology in the manufacturing site in Asia – Singapore.

Key Points discussed in this session:
-Why this technology is chosen
-Automated system interfaced with LIMS
-Qualification process

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  Pao Chun Lin

  Senior QC Specialist at GSK

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  Yong Jian Lee

  Lead Scientist at Charles River Laboratories (Singapore)

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  Michelle Peake

  Senior Consultant, Quality/Biopharma at SeerPharma Pty Ltd

Aligning with public interest in cell therapies and their safety, USP is progressing towards industry review of a new informational chapter about microbiological control in cell therapy manufacturing and chapters for microbiological contamination quality control tests of short shelf-life products. This presentation will share insights for the development of these valuable new chapters and key aspects that are the foundation of aseptic processing and testing of cell and gene therapies.

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  Donald Singer

  Senior Microbiology Technical Consultant, North America at Ecolab Life Sciences

With the expectations of CCS in Annex 1, how could a sterile fill-finish manufacturing site effectively implement the CCS? In this presentation I will be sharing about my experience in drafting CCS of a sterile fill-finish process, across the various unit operations and controls

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  Li Wei Chan

  Microbiology Manager at MSD International GmbH (Singapore Branch)

Different inspection methods and technologies are used in the pharmaceutical industry to minimize the risk of unintended particles entering the patient during the injection of parenteral medication. This presentation gives a brief overview of the different inspection methods (from manual inspection to AI-assisted inspection) applied in each stage of the product development process. It will also discuss how to assess the inspection results of a fully automated machine compared to a human manual inspection (Knapp test). Furthermore the presentation will highlight how inspection results can be improved by AI to achieve a better detection rate and to reduce costly false-rejects in production

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  Louis Doneck

  Area Sales Manager at Körber Pharma Inspection

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  Emily Cheah

  Managing Director of Charles River Laboratories (Singapore)