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March 10, 2024

Sterile Filtration Process Control: Meeting Regulatory Expectations

Sterile filtration is a pivotal process step in pharmaceutical manufacturing to ensure the sterility of injectable drug products. It eliminates microorganisms and particulates while safeguarding the integrity of a final product. Effectively managing and monitoring the sterile filtration process requires meticulous attention to manufacturing controls and encompasses key parameters such as flow rate, temperature, use time, and pressure. Pressure emerges as a critical factor, necessitating oversight to validate the efficacy of a filtration system and uphold the stringent standards of regulatory bodies such as the US Food and Drug Administration (FDA) and the European Commission.
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October 18, 2023

How AI and Machine Learning Can Bring Quality Improvements in Biopharma

Artificial intelligence (AI) and machine learning (ML) are easily confused, but it is crucial to recognize the fundamental difference between them. AI refers to prebuilt products that identify patterns based on human behavior around recognition and decision-making that utilize those patterns to enable platforms to answer questions, provide relevant information, or perform requested tasks. ML, meanwhile, employs mathematical algorithms to predict activities or outcomes based on data. ML is a subset of AI, meaning that although all ML derives from AI, not all AI is based on ML.1
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August 10, 2023

Unlocking the Benefits of FDA’s Orphan Drug Designation

Securing an orphan drug designation is no small feat, in part because the number of patients affected cannot exceed 200,000 in the United States, despite population growth over 40 years.
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September 8, 2022

Jake Black will be attending the Rocky Mountain Life Sciences Investor + Partnering Conference representing RMC

The Rocky Mountain Life Sciences Investor & Partnering Conference connects investors and strategic partners from across the U.S. with the region’s most promising startup and emerging companies. Focused exclusively on life sciences, it brings together investors and health innovators for networking, one on one partnering, and formal pitches in a relaxed mountain setting.
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September 14, 2021

A Research Agenda for Transforming Separation Science

The National Academy of Science has acknowledged Scott Rudge as a contributor to its report on national priorities for separation science. This report is issued once every ten years and gives the national priorities for funding advances in this very important field.
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November 18, 2016

CNBC Reports “Zika can survive for hours on hard, nonporous surfaces” citing research involving RMC staff participation

The Zika virus is able to infect people even after sitting out on a counter for several hours, according to new research. But the good news is that in that state, it is also easy to kill with common household chemicals…
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