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Dec 6, 2024 | 
bioprocessonline.com | Kishore Kumar Hotha |Michael Moussourakis |Jeff Phillips |Stacy Silverstein
Let Us Handle Your Buffer PreparationThermo Fisher Scientific is here to support you with the buffer preparation in your manufacturing workflow. Leaving the non-core activities to us enables you to focus on the patient therapy development. Our capabilities cover off-the-shelf products like WFI, NaOH, NaCl, or EtOH, a library of the most frequently used buffers that are made-to-order, as well as fully customized buffers.
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Sep 6, 2024 | 
bioprocessonline.com | Matthew Pillar |Todd Andrews |Michael Moussourakis |Jeff Phillips
FOCUS ON FACILITIES DESIGNThe wave of ADC (antibody-drug conjugate) development and manufacturing activity we’re currently witnessing, and importantly, the HPC (high-potency compounds) comprising the payloads in these therapies, demand thorough assessment of development and manufacturing facility design. Single-Use vs.
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Aug 13, 2024 | 
meddeviceonline.com | Yadnyesh Patel |Michael Moussourakis |Jeff Phillips |Stacy Silverstein
Join us at The MedTech Conference in Toronto from October 15-17. Connect with industry leaders, explore cutting-edge innovations, and help shape the future of health care. Experience the revamped Medtech Campus, hands-on tech showcases, interactive sessions, and unparalleled networking opportunities. Don't miss this chance to be part of the pivotal event in the medtech industry.
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Aug 9, 2024 | 
bioprocessonline.com | Matthew Pillar |Michael Moussourakis |Jeff Phillips |Stacy Silverstein
AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.
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May 17, 2024 | 
bioprocessonline.com | Erich Bozenhardt |Michael Moussourakis |Jeff Phillips |Stacy Silverstein
FOCUS ON FACILITIES DESIGNAfter decades of helping to rescue biotech and pharma companies from environmental monitoring excursions, Herman and Erich Bozenhardt bring this discussion about specific problems you should avoid. Steps For Proper Cleaning ValidationExamine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.
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May 16, 2024 | 
meddeviceonline.com | Erika Roberts |Michael Moussourakis |Jeff Phillips |Stacy Silverstein
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| May 16, 2024
The FDA recently announced that they have seen an increase in the number of entities that contract out testing or services where the data provided by said firms was fabricated, duplicated, or just deemed “unreliable.” Here's what you can do.
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Mar 12, 2024 | 
meddeviceonline.com | Edwin L. Bills |Christie Johnson |Jayet Moon |Michael Moussourakis
On February 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by February 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more.
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Jan 22, 2024 | 
pharmasalmanac.com | Michael Moussourakis
Michael Moussourakis (MM): Alconox offers more than 15 different types of detergents, each playing a different role and serving a different purpose. We continuously revisit the variety of surfaces our customers need to clean, including potential residues, to determine the most effective and suitable cleaning process. Additionally, a key consideration is deciding if the detergent should be offered in powder or liquid form.
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Aug 22, 2023 | 
meddeviceonline.com | Ruijin Song |Andrew Walsh |Michael Moussourakis |Jeff Phillips
ASTM E3106 emphasizes that cleaning agents and cleaning processes should not be adopted randomly, nor should they be chosen simply based on what has been used in the past. In this article, part of the Cleaning Validation For The 21st Century series, let's look at which cleaning parameters are critical and what are the optimal cleaning parameter settings, through the lens of design of experiments (DoE).
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Jun 15, 2023 | 
meddeviceonline.com | Kateryna Hronska |Kamran Zamanian |Michael Moussourakis |Jeff Phillips
By Kateryna Hronska and Kamran Zamanian, Ph.D., iData Research Inc. This article provides an overview on the five types of neuromodulation devices: spinal cord stimulation, deep brain stimulation, sacral nerve stimulation, vagus nerve stimulation, and gastric electric stimulation, as well as related market trends.
