Miriam Guest

Miriam Guest is the Senior Principal Scientific Advisor of Microbial Solutions. She recently joined the organization after 20 years with AstraZeneca. In her role, she provides scientific governance and strategic direction.

She has extensive experience in the pharmaceutical Industry leading contamination control strategies for drug development projects as well as supporting internal and external manufacturers to provide microbial quality assurance of drug products. In her previous role, she led the Global Microbiology Forum, connecting over 25 microbiology labs across the world, to drive standardization and quality improvement initiatives. 

Miriam provides senior-level guidance to drive innovation for Charles River’s microbiology testing solutions. In addition, she sits on the British Pharmacopoeia panel of experts in microbiology, the European Pharmaceutical Review's Editorial Advisory Board and is an active committee member of Pharmig, the Pharmaceutical Microbiology Interest Group, and historically has supported initiatives such as RDPAC on harmonization projects in China.

With over two decades in pharmaceutical microbiology across both drug product manufacturing and clinical development, Miriam offers extensive expertise spanning quality control laboratories, formulation research and GMP production environments. Her perspectives are further enriched through regulatory interactions around designing and authoring robust control strategies for complex supply chains.

Miriam has also spent time as facility microbiologist in sterile manufacturing, on a multi-product, clinical trial production facility, providing oversight and ownership of environmental monitoring, water systems, sterilizers and aseptic simulation trials.

LinkedIn Profile

Publications:

• Considerations for Sterility Test Methods When Working with CDMO’s – Outsourced Pharma – Miriam Guest January 2023
  • Considerations For Sterility Test Methods When Working With CDMOs (outsourcedpharma.com)
• Considerations for Microbial Enumeration Methods when working with CDMO;s – Outsource Pharma – Miriam Guest – Jan 2023
  • Considerations For Microbial Enumeration Methods When Working With CDMOs (outsourcedpharma.com)
• Clean Air Containment Review: adoption of enzyme indicators – November 2022 publication– Stephen Dawson, Miriam Guest
• CACR 48 IS OUT NOW! CACR 48 IS OUT NOW!, (cleanrooms-ireland.ie)
• A Strategic Approach to optimization of testing bacterial Endotoxins, European Pharmaceutical Review. Vol 27, Issue 4, August 2022 – Publication – Miriam Guest, Karen Capper, Dennis Wong, Phil Duncanson
  • A strategic approach to optimisations of testing bacterial endotoxins (europeanpharmaceuticalreview.com)
• Initial Evaluation Roadmap for Modern Microbial Methods – Claire Fritz Briglia, Miriam Guest, Lynn Johnson, Amanda McFarland, Nina Moreno, Allison Scott
  • Initial Evaluation Roadmap for Modern Microbial Methods | PDA
• AstraZeneca’s Steps in Implementing a Technology Uplift of its Microbiology Labs, Pharmaceutical Online, Guest Column, 31^stMay 2022 – Publication – Miriam Guest
• AstraZeneca’s Steps Implementing A “Technology Uplift” Of Its Microbiology Labs (outsourcedpharma.com)
• Rapid Methods the Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing. BioPharma Asia, Volume 11, Issue 1, January/February 2022 & May 2022 Pharmig Newsletter - Miriam Guest, Sophie Drinkwater, Karen Capper
• Rapid Methods the Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing • Biopharma Asia (biopharma-asia.com)
• How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development with Enzyme Indicators, Guest Column, Pharmaceutical Online, 22^ndDecember 2021 – publications – Stephen Dawson and Miriam Guest (Top 10 article for 2022)
• How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development With Enzyme Indicators (outsourcedpharma.com)
• Reflections on the Atlantic Horseshoe Crab – EJPSS, 253 (2020)
• Microorganism Challenges on Online Water Bioburden Analyzers: Pitfalls and Best Practices – part of a cross industry group – published March 2020 on Pharmaceutical Online
• Experimental Methods for Microorganism Challenges on Online water bioburden analyzers - part of a cross industry group – published Feb 2020 on Pharmaceutical Online

Presentations:

• Webinar: Transform the Future of Sterility Testing with Digitalization
• Webinar: When Innovative Formulations Cloud Sterility Testing
• European Microbiology Conference June 2024 – Enzyme Indicators
• 6^th Aseptic Processing Summit – June 2024 – Microbiology Technology Strategy
• Where did they come from? Considerations for Test Strains – presentation, Pharmig Conference December 2022, Miriam Guest, Christine Farrance
• Modernisation of the Pharmaceutical Laboratory: Enterprise-wide technology strategy – October 2022 – keynote presentation at SAE Next Generation Pharmaceutical Cleanroom Conference
• Contamination Control Strategy for Steriles – Presentation – Rachel Law/Miriam Guest – Pharmig CCS virtual event – July 2022
• Intubio webinar – why we might need rapid bioburden – guest presentation 24^thMay 2022 – Miriam Guest
• Around the World in 80 Ways – Harmonized Programs, Processes and Technology Enterprise Wide – presentation, Kenx Cleanroom University April 2022 – Presentation – Miriam Guest
• AstraZeneca’s Sterile Manufacture Technology Strategy: Background, Benefits and Progress, DIA Europe March 2022 – Presentation – Miriam Guest
• Rapid Sterility The Next Phase: Webinar with biopharma Asia January 2022 (presentation)
• Microbial Identification: maximizing the data value of pharmaceutical flora. ECA Pharmalab Congress 22^ndNov 2021 – Presentation – Miriam Guest
• Microbiology Labs of Tomorrow. Pharmig Annual Conference Nov 2021 - Presentation – Miriam Guest
• Rapid Sterility Testing -CASS EU CMC Strategy Forum Europe SOC Conference , Oct 2021- Presentation – Miriam Guest
• Rapid Methods – the next phase – PDA Global Microbiology Conference – Oct 2021 Presentation – Miriam Guest
• Sustainability and Conservation Considerations for Endotoxin Testing – Lonza’s 6^th Global Endotoxin Summit – Sept 2021
• Endotoxins: LAL Today/LAL Tomorrow Pharmig Virtual Event – June 2021 – Event Chair and presenting “Setting the LAL Sustainability Scene”
• Building High Performing Labs at AstraZeneca – Industry Event Exchange on Lab of the Future – Oct 2020 – Presentation with Jufang Wu Ludvigsson
• Benefits of tweezerless transfer in bioburden testing – Online bioburden webinar – April 2020
• Sterility Assurance without Boarders – APS Pharmaceutical Event – presentation July 2017

Other:

• European Pharmaceutical Review - Collaboration in Microbiology. Allison Scott, Lynn Johnson, Miriam Guest May 2023
  • Collaboration in microbiology - EPR Podcast 19 - M3 Collaboration (europeanpharmaceuticalreview.com)
• Ideagen Breaking Silos podcast. Technology Uplift and Collaboration – Feb 2023:
  • S1 EP4: “Technology Uplift” and collaboration | Ideagen
• Why BioPhorum’s modern microbial methods evaluation roadmap is a foundation for success – Biophorum website July 2022
• Podast: Modernizing Microbiology – European Pharmaceutical Review Podcast Episode 15 – September 2022 - Sophie Bailes and Miriam Guest
  • EPR Podcast Episode 15 – Modernising microbiology – Sophie Bailes and Miriam Guest, AstraZeneca (europeanpharmaceuticalreview.com)
• Cleanroom Technology, In Conversation with AstraZeneca, a recorded interview on microbial identification April 2022) – You Tube – Miriam Guest

Cleanroom Technology in conversation with AstraZeneca

• Interview with Miriam Guest, Pharmig Newsletter Feb 2022
• Panelist – Harnessing the Potential of Scientific Data and Advanced Lab Connectivity for Smart Labs event – December 2021 – Panelist – Miriam Guest

Horseshoe crabs and the pharmaceutical industry: Challenges and Alternatives – Wellcome Trust, Animal Research Nexus, RSPCA – Dr Richard Gorman – anonymous contributor