Episodes
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Anke Hossfeld (Merck) joins us in this podcast episode on Automation and Digitalization to share her experience on why pharma labs must adapt to the trend to meet Industry 4.0 demands and why choosing the right partner is key.
Timestamps:
[2:00] Merck’s Automation and Digitalization Strategy
[3:25] Skilled labor challenges in Pharma
[4:05] Pharma needs automation (advantages and constraints)
[7:25] Establishing a network of expertise is key to implementing automation
[9:51] Merck’s solutions for Robust contamination control strategies
[12:15] Pilot projects on robots performing QC sampling in cleanroom
[13:37] Automation and digitalization are assisting microbiologists
[15:49] Merck’s M-Trace software for data integrity
[17:35] Pharma wants harmonization of supply
[20:18]: Merck meets Industry 5.0 goals
Biography:
Anke Hossfeld, Director Marketing – Automation & Digitalization, Science & Lab solutions - Biomonitoring, Merck, Darmstadt, Germany
Anke Hossfeld is Director of Marketing for Automation and Digitalization at Merck in Darmstadt, Germany. She is responsible for the innovation strategy of new products for microbial QC testing in the pharmaceutical industry using automation, robotics, and digitization. Anke started her career in 2008 at Biotest AG as International Product Manager for alternative pyrogen and mycoplasma tests. In 2011, Anke joined Merck in Darmstadt as Global Product Manager and has since been responsible for the product portfolio, life cycle management, and new product developments in various QC applications such as bioburden, sterility, pyrogen, and rapid technologies. -
Missing episodes?
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Denise Bolton (New Hampshire PHL) and Carol Loring (INTEGRA Biosciences) bring their public health expertise to this podcast’s discussion on how we can be better prepared for the next pandemic by using what we’ve learned from the last one.
Timestamps:
[5:00] - Liquid handling of COVID-19 samples before and after rapid instruments were employed
[6:45] - INTEGRA's rapid instruments built to avoid repetitive strain injury
[11:49] - Challenges in handling Monkeypox virus samples at public health lab
[12:40] - Responding to outbreaks with rapid testing and instrumentation
[15:28] - Be prepared, as there's no time in an emergency situation to research new equipment
Biographies:
Carol Loring
Known for her expertise in optimizing laboratory workflow and overcoming bottlenecks, Carol Loring is a Field Applications Specialist with INTEGRA Biosciences where she collaborates with internal and external partners to resolve lab automation challenges, build relationships, extend learning, and achieve success in accelerating science.
Ms Loring's experience as a laboratory supervisor honed her skills in molecular diagnostics and disease surveillance, laboratory quality assurance, biosafety, and staff development. She previously served on the Influenza and Respiratory Viruses Subcommittee at the Association of Public Health Laboratories, and as a consultant for the Centers for Disease Control and Prevention has performed Laboratory Assessments in Ivory Coast, Sri Lanka and Maldives. For two years Ms. Loring served as a quality assurance Mentor for the National Influenza Laboratory of Mozambique. In her free time, Ms Loring enjoys hiking the trails and summitting the peaks of the White Mountains of New Hampshire.
Denise Bolton
Denise is a technical supervisor at the NH Public Health Laboratories, overseeing the Emergency Response Rapid methods testing (LRN) and Arbovirus surveillance.
Denise graduated from the University of New Hampshire in 1983 with a degree in Microbiology. She began her career in Public Health right out of college, working for the NH Department of Health & Human Services for the last 39 years, mostly in the lab. While at the PHL, she has been involved in some very interesting work, including the onset of West Nile virus in the US in 2000; the Influenza H1N1 pandemic; an anthrax incident involving a drumming circle; a drug-diversion case that resulted in a Hepatitis C outbreak; preparation for the 2014 (Zaire) Ebola outbreak and the recent (Sudan) Ebola outbreak; the Zika virus outbreak; and of course, the COVID pandemic.
Denise is married and has 4 grown children and 4 granddaughters. She is planning to retire this spring and hopes to spend more time with all of them. Her hobbies include hiking, photography, reading, and baking -
To view transcript and visit supplier's page, please follow the link: https://www.rapidmicrobiology.com/news/fighting-epidemics-with-molecular-diagnostics-from-h7n9-to-monkeypox-podcast
Timestamps:
[1:37] - Responding to outbreaks quickly with molecular diagnostics
[3:49] - Pioneers in RT-PCR and immunochromatographic assays
[5:04] - Protecting lab technicians from pathogens and avoiding cross-contamination
[8:00] - Increased awareness in prevention of infectious diseases with rapid and molecular diagnostics
[9:30] - Bioperfectus' diagnostic portfolio and global partnerships
[12:07] - Quelling pathogens before they spread -
In this podcast episode, our guests from Sartorius give advice on correct pipetting techniques that will avoid cell damage and reproducibility errors.
Timestamps:
[2:09] - Research papers without the pipette method leads to reproducibility errors
[3:56] - Incorrect pipetting damages cells
[4:38] - Reverse pipetting
[6:46] - Optimizing pipetting steps for infectious disease research
[8:43] - A pipette with smart features will help the researcher
[12:05] - Sartorius Pipetting Academy
Speakers:
Sandra Söderholm earned her PhD in Biochemistry from the University of Helsinki in 2016. In her thesis work, she investigated innate immune responses to Influenza A virus. After completing her PhD, she worked as a Post-Doctoral Researcher at Professor Dirk Bumann’s laboratory at Biozentrum (University of Basel, Switzerland), where she studied Pseudomonas aeruginosa and Staphylococcus aureus in clinical samples with mass spectrometry-based proteomics, to identify novel strategies to combat infectious disease and antibiotic resistance. She joined Sartorius as an Application Development Scientist in 2019.
Jennifer Labisch studied molecular biotechnology in Bielefeld and Frankfurt. She was a Sartorius scholarship holder during her master studies, and after her master thesis at Sartorius in Göttingen, she continued to work at Sartorius as a PhD student. She is working on downstream processing of lentiviral vectors. Her research includes clarification and analytics with a focus on steric exclusion chromatography. -
The ReadyStream® System is a revolutionary pre-enrichment workflow in food pathogen testing, removing the legwork and hands-on time conventional methods require. Listen to Scott Medley (Global Product Manager, Merck KGaA, Darmstadt, Germany) explain its novel features and benefits in this rapidmicrobiology podcast.
Timestamps:
[1:03] - The ReadyStream® System's functions and purpose
[1:46] - Advantages over other rehydrate media on the market
[3:16] - The story of its invention
[5:07] - Energy and water savings to be made
[8:11] - What happens if I don't use all the bag in one day?
[9:02] - Media traceability
[10:45] - ISO Standard compliance
[11:50] - How is it operated under a laminar flow hood?
[13:41] - ReadyStream's versatility
Biography
Scott Medley is a Global Product Manager at MilliporeSigma/Merck Bellevue, USA responsible for Immunoassay pathogen testing products such as; 1-2 Test, VIP Gold, SinglePath, and TRANSIA EIA assays. Scott has worked in various laboratory-based roles for companies such as Fred Hutchinson Cancer Research Center and Bloodworks Northwest and for Siemens Healthineers as a technical application specialist and sales specialist. In 2017 he joined MilliporeSigma/Merck Bellevue USA as a Global Product Manager -
In this podcast, Andre Alfaro, Director of Assay Development at nanoComposix, lends expertise to medical device manufacturers entering the LFT market, particularly for COVID-19. Andre provides insights into this fast-growing sector and explains how nanoComposix can help every step of the way.
Timestamps:
[0:44] - nanoComposix's lateral-flow development services
[3:50] - Developing a SARS-CoV-2 lateral-flow test and bringing it to market
[4:58] - The beauty of antibody tests
[7:47] - Why choose nanoComposix?
[9:50] - How precious are gold particles?
[13:32] - Health product agencies raising the quality standards bar
[15:20] - 1st gen assays that gave the rapid test a bad rap
[19:20] - How robust is your supply chain?
[21:45] - We're on top of mutating viruses
[22:50] - Saliva-based tests are the way forward
[25:34] - Lateral-flow can do it in 60 seconds
[27:05] - ISO Standards
[27:56] - Talking to experts enables proper planning -
Listen to our latest podcast and learn how InnovaPrep's rapid method enabled GT Molecular to lead the field in wastewater epidemiology for SARS-CoV-2. Guests include Rose Nash (GT Molecular), Dave Goad and Dave Alburty (InnovaPrep).
Timestamps:
[1:11] - SARS-CoV-2's Achilles' heel (Rose Nash)
[3:58] - Data for Action! (Rose Nash)
[6:06] - Reducing turnaround times in wastewater epidemiology (Rose Nash)
[8:24] - Choosing a concentration method (Rose Nash)
[9:31] - The science behind the InnovaPrep Concentrating Pipette (Dave Goad)
[14:20] - Sample sizes for wastewater epidemiology (Dave Goad)
[16:25] - Recovery rates (Rose Nash & Dave Goad)
[20:32] - New pre-filter product (Dave Goad)
[25:08] - True concentration factor (Dave Goad and Dave Alburty)
[28:44] - Normalize data using controls (Rose Nash)
[31:37] - Wastewater epidemiology - past, present, and future (Dave Alburty)
[36:07] - Digital PCR vs RT-PCR for wastewater samples (Rose Nash)
[42:07] - Surveillance of variants in the community (Rose Nash)
[44:55] - The power of modern rapidmicrobiology techniques (Dave Alburty) -
In this episode, our guest Tim Adams from Tecta-PDS talks about the success of the Tecta B16, the world's only approved portable rapid automated test for water, and explains how its user-friendly design and testing capabilities are knocking everything else out of the water.
Timestamps:
[1:40] - Explanation on why the Olympics committee chose the Tecta B16 for water testing
[4:00] - How it works
[7:55] - Differences between Tecta-PDS technology and other tests on the market (cost etc.)
[9:56] - If no special training is required, how user-friendly is the Tecta B16?
[12:47] - Origins of its invention
[17:30] - US EPA approval for testing drinking water
[19:30] - Validated for food and beverage applications and international approvals
[23:15] - First nations and Africa success stories
Biography:
Tim Adams, having lived and worked in multiple countries, has over 25 years of senior leadership experience heading up sales and marketing teams worldwide in various markets, including clean-tech, hi-tech, professional services, manufacturing, telco, and software. He joined the company in 2012 as Vice President, Sales & Marketing, to lead the worldwide effort for Veolia Water’s innovation division, ENDETEC, which consisted of TECTA-PDS and several other advanced monitoring businesses. In 2016, along with his partner Doug Wilton, he led a management buyout of the division, bringing the entire business and operations back to Canada. He holds a BA from Brock University as well as an International Certificate of Marketing from Harvard University. -
In this episode, Adele Gisselmann (Global Product Manager with Merck KGaA Darmstadt, Germany) describes the challenges of performing environmental monitoring in isolators, like manipulation with thick gloves and the effect of VHP, and explains how smart product design overcomes these challenges.
Timestamps:
[0:40] - Differences between environmental monitoring (EM) in isolator and cleanroom
[2:05] - Performing EM with thick neoprene gloves
[2:53] - Handling air samplers
[3:38] - What impact does VHP have on EM?
[5:11] - Neutralization of VHP residues
[6:10] - Storing material for EM during the production run
[7:25] - Taking away swabs and plates safely after sampling
[8:05] - Guidance in Annex I? -
In this episode, Laure Robert (Global Product Manager with Merck KGaA Darmstadt, Germany) emphasizes the importance of pyrogen testing with MAT as a final release test, gives reasons for geographical differences in MAT standardization, and describes how to implement MAT in the lab, step-by-step.
Timestamps:
[1:00] - Contaminant Limit Concentration
[3:00] - Rabbit Pyrogen Test (RPT) or Monocyte Activation Test (MAT)
[6:20] - Standardization of MAT
[7:45] - Why perform a pyrogen test as well as BET?
[11:03] - PyroMAT system comparison to competitors
[14:04] - QC for pyrogens
[17:10] - Implementing MAT in the lab
Speaker:
Laure Robert is a Product Manager working within the BioMonitoring organization of Merck Life Science. She took this role in 2017 and has been in charge of pyrogen testing solutions since then. During this experience, she had the opportunity to launch a new monocyte activation test solution on the market, namely PyroMAT® System.
Before joining Merck, she had experience as a product manager within the pharmaceutical industry for two years and then held a position of consultant within the healthcare sector for two more years. She holds a Pharm. D degree obtained at the University of Lille, France, and a Master’s degree in Business Management (EDHEC Business School). -
The food industry is constantly innovating – we have new protein sources like insects and algae, we have new packaging materials, we have new formulations reducing sugar and salt, other preservatives – how do manufacturers keep their shelf life dates relevant to their product changes? We’ll find out from food safety expert Linda Everis who currently manages the challenge test/shelf life studies at Campden BRI.
Timestamps:
[1:05] - 'Use-by' or 'Best-before'
[4:18] - Challenges with extending shelf-life
[7:05] - Determining safe shelf-life
[8:26] - Determining quality & open shelf-life
[13:11] - Listeria
[16:20] - Consequences of a badly-designed challenge test
[18:52] - Advanced Microbial Profiling (AMP)
[20:51] - Predictive Microbiology -
In this episode, Anne Klees and Adele Gisselmann (Global Product Managers with Merck KGaA, Darmstadt, Germany) unravel the New GMP Annex I (Draft 2020) and explain what effect its changes and new sections will have on environmental microbial monitoring.
Timestamps:
[1:20] - Key Changes in Annex I
[2:31] - Rapid and Alternative Methods in Annex I
[6:10] - Qualification of Recovery Rates for Air Samplers & Culture Media
[7:45] - Validating Media for its Neutralization Efficiency
[9:05] - Validating Air Samplers
[14:40] - New Sections in Annex I (Aseptic Process Simulation/Media-fill etc.)
[20:28] - How Merck KGaA, Darmstadt, Germany can help with Regulatory Requirements
Speakers:
Dr Anne-Grit Klees, is a Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She is a microbiologist and graduated at Philipps Universität Marburg in 1992. Since then she has been Global Product Manager for Biotest, heipha Dr Müller GmbH and Merck Life Science with strong expertise on environmental monitoring in pharmaceutical industries including ready-to-use culture media for air, surface and personnel monitoring.
Adèle Gisselmann is Global Product Manager for Environmental Monitoring at Merck KGaA, Darmstadt, Germany. She has three years of experience in technical support for process solutions at Merck KGaA, Darmstadt, Germany, and a background in the food and beverage industries and microbiology. -
In this episode, Andy Whittard (Managing Director at Cherwell Laboratories) and Gethin Jones (Managing Director at Pinpoint Scientific) lend their expertise to environmental monitoring in pharmaceutical manufacturing, focusing on the changes to continuous monitoring in the proposed Annex I.
Timestamps:
[0:45] - Differences Between Air monitoring & Air sampling
[4:53] - Difficulties in Setting up New System + Case Examples
[9:28] - Importance of High-Collection Efficiency
[11:20] - D50 Explained
[12:29] - Sieve vs Slit-to-Agar Samplers
[14:55] - Continuous Monitoring for Viables in New Annex I
[19:30] - Minimizing Contamination Risk
[21:52] - Adoption of Rapid Methods vs Reconfiguration of Existing Ones
[25:20] - Data Integrity Requirements
Speakers:
Andy Whittard - Managing Director Cherwell Laboratories & Director Pinpoint Scientific
Andy has been MD at Cherwell for 15 years. This family-owned business celebrates 50 years in business this year. Cherwell focuses on delivering cleanroom microbiology solutions to its customers in pharma and associated industries across the UK and Europe, through its own range of prepared microbiological media products and distribution of air sampling and monitoring equipment.
Gethin Jones - Managing Director Pinpoint Scientific
Gethin is founder and MD of Pinpoint Scientific, which was formed in 2011. Before setting up the company, Gethin was R&D manager for a global biotech company and could see that the market products were not addressing the changing regulations in the pharma industry.
Gethin saw an opportunity to develop a range of Annex 1 compliant Microbial Air Monitors, and that is exactly where we are today. Pinpoint Scientific has developed a core monitoring technology platform based on well-established and trusted methods that can be packaged into a range of instrument formats to suit isolators and portable general monitoring applications. Gethin is an electronics & mechanical engineer by training with 30 years experience in biotech product design. -
In this episode on Legionella testing, we have Ray Petrisek, a principal investigator in the discovery of Legionella in the ‘70s, who gives advice on testing and sampling for Legionella and the limitations and advantages of test kits in today’s market. Timestamps:[4:47] - Legionella discovery in the lab
[12:13] - Testing for Legionella in Potable water
[13:51] - Sampling: “Look for the biofilm, and you’ll find Legionella”
[21:21] - Limitations with plate-based method & PCR
[29:54] - Preferred test method; IDEXX Legiolert
[35:13] - Ongoing problems with Legionella
Speaker:
Raymond Petrisek serves as a senior microbiologist and infectious disease microbiologist at HP Environmental. He is certified by the American Society of Clinical Pathology (ASCP), both as a medical technologist (MT) and specialist in microbiology (SM). Ray has over 35 years of experience in medical and healthcare environmental management and environmental microbiology. Among his many responsibilities, he conducts numerous investigations including but not limited to indoor air quality investigations and assessments of water-damaged or mold-impacted building materials.
