Bioprocessing and Pharmaceutical Filtration
A Guide to Biopharmaceutical Filter Qualification
Filter qualification typically involves demonstrating bacterial retention of a filter under process simulated conditions. A crucial first step in this is in the hands of the filter vendor, who...
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Automating and Enclosing Bulk Fill Operations - the Way Forward?
The consequences of failure during downstream processing are severe. Following the Affinity Chromatography stage, the value of the product increases significantly at every step. A failure at the final...
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Mycoplasma Contamination: Understanding the Risks and Taking on the Challenges
Mycoplasma contamination events, although rare, can have an enormous and immediate negative impact on biomanufacturers leading to reduced productivity and delays in products reaching patients. Parker...
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The Biopharmaceutical Industry's Definition of Integrity
One of the challenges faced in any biopharmaceutical process is bioburden control and containment — or how do you keep what is out, "out" and what is in "in". For a stainless steel-based manufacturing...
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Filtration and Biopharmaceutical Process Protection
Effective filtration is vital to process protection and factors such as filter selection, testing and optimization can have an impact on process risk. Here we examine the factors to consider when...
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Protecting Your Bioprocess From the Risk of Human Error
In Parker Bioscience’s webinar entitled Protect The Process, Protect The Patient, the concern that biopharmaceutical manufacturers have regarding the impact of human error on their processes was all...
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Most Popular Filtration Technology Blogs of 2017
2017 saw economic growth accelerate and the indicators suggest that trend will continue. This puts productivity initiatives high on the list of manufacturers, keen on taking full advantage of...
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A Guide to Business Continuity Planning for Biomanufacturers
Picture the scene: Unprecedented rainfall and poor flood defences causes flooding to a biopharmaceutical facility, damaging equipment, making large areas of a site unsafe and inaccessible, and...
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Protecting Your Process From Mycoplasma Contamination
Plant shutdown, a shortage of key products, patients unable to access important drugs, profits hit … the consequences of a biological contamination can be devastating for a...
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Eliminating Leaks and Faults: Single-Use vs Stainless Steel Systems
Ensuring process integrity – which means being able to effectively test for leaks – is a critical factor in biopharmaceutical manufacturing processes, especially given the high value placed on drug...
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Automated Single-Use Technology and Its Impact on Quality
Taking steps to understand and control process variation is crucial to biopharmaceutical manufacturers. The sentiment behind the old adage, "the product is the process" can’t be dismissed.  ...
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Five Critical Challenges in Single-Use Bioprocessing
Single-use technology plays an integral part in nearly all bio-production processes, yet several challenges remain —challenges that are serious enough to delay or even stop the use of...
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Process Protection: What Does It Mean to You?
Imagine the scenario: Your new blockbuster drug is making a significant difference to the lives of patients. But then your supply chain fails, taking the product out of circulation. The consequences...
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Engineering Managers: Streamline Your Bioprocess With Automation
Twenty years ago, Professor Bernhard Sonnleitner, of the Institute of Chemistry and Biological Chemistry at the Zürich University of Applied Sciences, suggested that the bioprocess industry would...
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What's Stopping You From Automating Your Single-Use Process?
The use of automation in running complex single-use systems has many benefits such as process control and consistency, increased speed, reduced labour costs and operational flexibility....
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Overcoming Barriers to Single-Use Implementation
Single-use technologies have emerged as a significant and growing resource in the biopharmaceutical industry but there is still some trepidation around their use, meaning that some manufacturers are...
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Design Space and its Use in Single-use Bioprocessing
The design space - a toolbox of validated parts and assemblies - allows an end-user to build any single-use device needed, utilizing a combination of validated parts.    Tubing, filters, connectors...
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How Can Biomanufacturers Achieve Standardization of Single-use Assemblies
Major delays in getting products to market, higher costs generated by design, testing, and management, increased lead times due to low-volume production runs and the changeover processes...
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Has Single-use Customization Gone too Far?
Single-use technology (SUT) has been adopted on a global scale since its introduction 20 years ago and its benefits are well-recognized.   Thousands of single-use products are now in use and entire...
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Four Sources of Process Variation in Biopharmaceutical Manufacturing
Given the difficulty of linking the molecular structure of a complex biopharmaceutical to its efficacy and safety, the industry must maintain that “the process is the product”. Any change to...
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