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08 17 21 -- 10 Critical Validation Parameters For Microbiological Experiments
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
05.25.21 Are You Approaching LIMS Validation Correctly?
Sanofi wanted to upgrade from an existing batch chromatography process to the BioSMB multicolumn format, then scale up that process to a continuous perfusion run. This case study details the real-world results.
Featured Editorial
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Laboratory information management systems (LIMS) are an established part of larger laboratories. However, different LIMS vary in their scale, functionality, and quality. This article considers the essential validation criteria for LIMS to ensure the system functions as a compliant component in the digital backbone of the modern laboratory.
Industry Insights
05.13.21 Biopharma Cold Chain Logistics 101
Life sciences companies face major challenges to continued operations and profitability including patent expirations, low R&D productivity, increased competition, decreased margins, nonoptimized processes, and mounting compliance pressure. Join us on May 25, 2021 at 11:00 a.m. EDT, to understand the technologies needed to meet today’s requirements, how to spend more time on science and less time correcting data, and how to improve efficiencies in process development, collaboration, and product quality.
By Curtis Gippe, Adept Packaging
Cold chain logistics can be complex and intricate. Maintaining the integrity of controlled-temperature products requires holistic consistency between design and development, manufacturing and packaging, qualification and validation, cold storage, transportation, and monitoring as the product moves from its point of origin to the end user.
Pelican BioThermal Announces Partnership With Asiana Airlines
pharmaceuticalonline.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from pharmaceuticalonline.com Daily Mail and Mail on Sunday newspapers.
02.16.21 Do These Recent Warning Letters Signal A Shift In FDA Enforcement?
Upload an image of your current/old CO2 incubator for a chance to win a brand new FREE NuAire In-Vitrocell NU-5810 CO2 Incubator. Other prizes include a monthly drawing for a branded Under Armour backpack, Camelbak metal water bottle, and various gift cards. All entries will receive a FREE NU-1582 CO2 Incubator Castered Platform with your next NuAire CO2 Incubator purchase. Contest valid until 7/31/2021. Restrictions apply.
Featured Editorial
By Barbara Unger, Unger Consulting Inc.
The FDA posted two unique warning letters that all pharmaceutical and API firms, regardless of their product category, should consider and evaluate. These first-of-a-kind warning letters represent a renewed emphasis on both alternatives to on-site inspections and the importance of purchasing controls and supplier management.
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