Single-Use Technology: The Next 5 Challenges to Conquer
Now that single-use technology plays a part in nearly all bio-production processes, what is next? Several challenges remain that are still serious enough to delay or even stop the use of single-use technology, which in turn can extend the time to market and increase the cost of lifesaving biopharmaceutical products. Of the existing difficulties, which five are the most critical?
Biomanufacturers: How to Reduce the Complexity of Custom Single-use Assemblies
If more than 85% of your single-use assemblies are customized, you are likely overcustomizing at the expense of time, performance and quality. This white paper discusses the benefits of standardizing single-use assemblies within a validated design space to overcome challenges of single-use implementation.
The Effectiveness of PROPOR TFF Filters can be Demonstrated in Microfiltration and Ultrafiltration Applications
In this application note, we examine the performance and scaleup of PROPOR TFF, Parker domnick hunter's new range of hollow fibre filters in an E.coli lysate clarification, a mammalian cell culture clarification and a concentration of a fusion protein.
Mind the Gap: Ensure Successful Scale-up of Single-use Processes
The increasing distance between new molecular entities output and pharmaceutical spending is often referred to as the Innovation Gap. Parker domnick hunter examines the single-use explanation for this and reveals the considerations to ensure successful implementation of single-use automation from laboratory-scale to large-scale production.
Biologics QbD Case Study: Characterizing a Final Sterilizing Filtration Step
Parker domnick hunter outlines the process of quality by design and how it can be used within a bioprocess to ensure consistency of a final product using the example of a final filtration of a drug product.
The Accuracy of SciLog® SciPres Single-use Pressure Sensors
This article takes a closer look at the performance of the SciLog® SciPres single-use pressure sensors and how they can add an impressive degree of accuracy to a bioprocess.
A Strategy for Avoiding Manual Errors in Biomanufacturing
Bioprocess variation attributed to operator error can be costly, leading to decreased process efficiency and reduced product quality. Parker domnick hunter explains how the application of the skill, rule & knowledge framework (Rasmussen, 1990) can be applied to classify such errors and determine the appropriate use of single-use automation to help prevent manual errors from occurring.
Confidence When Scaling-Up
By using a structured, analytic approach under simulated process conditions at the experimental stage, it is possible to accurately predict filter performance at cGMP level. Parker domnick hunter explains more...
Can we Win the War Against Mycoplasma Contamination?
Biopharmaceutical manufacturers can suffer significant financial losses as a result of a Mycoplasma contamination in a cell culture. Preventing this, though, is easier said than done. This article reveals more about the structure of these troublesome microorganisms and detail a study to determine the link between filtration pressure and Mycoplasma retention rates.
Square Pegs in Round Holes
This article discusses how understanding bioprocess variation ensures facility fit during technology transfer.
Overcoming Obstacles in Final Ultrafiltration Steps
Parker domnick hunter discuss the challenges associated with final ultrafiltration steps in bioprocessing when preparing your product for the vial.
HarvestClear Filtration System for Harvest of Small-Scale Bioreactors
This application note describes a fast and easy system, which is ready-to-use straight from the box, its features, and its use in clarifying 1L to 20L of high density fermentation batches of Chinese Hamster Ovary (CHO) cells.
A SciLog® MabTec Method for Manual Bolus Fed-Batch Versus Automated Continuous Fed-Batch
Application note demonstrating MabTec's ability to increase protein production while eliminating several hours of manual daily operations.
The Role of Prefiltration in the Optimization of Biopharmaceutical Filtration Systems
Filtration costs within manufacturing facilities can be optimized by the appropriate use of prefilters. This application note examines how.
Controlling Bioburden Within Biopharmacuetical Manufacturing Processes
The manufacture of biopharmaceuticals requires multiple operations in order to deliver a product of appropriate quality and potency to the patient. This whitepaper explores how to ensure either sterility or the control of bioburden within process streams.
Effective Filtration of Common Buffers
The growing pressure to maximize throughputs and minimize production time means the optimization buffer filtration stages has never been more important. This application note describes Parker domnick hunter's solutions for buffer filtration.
Optimized Sterile Filtration of Pharmaceutical Solutions
This application note tells the story of the development of the PROPOR HC filter in partnership with a major pharmaceutical manufacturer, which has been shown to overcome significant processing problems associated with their production of a drug intermediate.