Search results for " low pH"

Article Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge. By Thomas A. Little, PhD To control the consistency and quality o…

Article Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing. By Claudio Denoya …

Article Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO. By Jim Miller While industry participants and observers talk about the “CMO industry,” they know that …

Article Microbiological Testing: Time is of the Essence
Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods. By Cynthia A. Challener Effective microbiological testing during biopharmace…

Article Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict. By Randi Hernandez Demand for any given new product is typically only known after significant investments h…

Article Connect Alias™ Autosampler to ÄKTA™ Pure or ÄKTA Avant
Need to purify a large number of samples? When working with a large number of small volume samples, sample injection into your protein purification system can be tedious and time consuming. To m…

Article A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media. By Satish Mallya, Benjamin Lay, Lihong McAleer, Alexa…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article Continuous Processing for the Production of Biopharmaceuticals
In that experiment, a continuous low pH hold was added to perform continuous viral inactivation. The whole assembly had the capacity to produce end-to-end continuous production from bioreactor to the …

Article Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing? By Rajeev J. Ram In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…

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