Biomanufacturing White Papers and Case Studies
-
Low-Volume Production For Screening High-Value Nanoparticle Materials
4/18/2022
A platform which harnesses microfluidic mixing has been demonstrated as a simple, robust and scalable production method for LNPs encapsulating various types of nucleic acids.
-
How Controlled Freezing Becomes Reality
2/17/2022
Controlling the freezing behavior of bulk drug substance is the ultimate goal in biopharma manufacturing. This study demonstrates the impact of ice front growth speed on scalability of freezing protein solutions.
-
How To Build A Robust Packaging Strategy For Rapid Commercialization
8/3/2021
Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.
-
Bulletproof Supply Chain: Hope For The Best, Prepare For The Worst
8/3/2021
How to incorporate flexibility in planning to overcome potential challenges, the value of having a contingency plan, and how a risk-based approach can determine where a contingency plan is needed.
-
Qualification Summary: Shippers For CelsiusĀ® FFT | FFTp 12L With Safecoreā¢ Technology
6/11/2021
Since it is not possible to anticipate every possible transport route, a set of industry-recognized tests was selected to represent a challenging use scenario. The two main risks to frozen material during transport are mechanical and thermal. In this note we have evaluated the Celsius® FFT | FFTp Box Shipper and Celsius® FFT | FFTp Bulk Shipper using the ASTM D-4169 test for mechanical risks and the ISTA 7D test for thermal risks.
-
Single-Use Bags Compatibility With Dimethyl Sulfoxide (DMSO)
6/2/2021
This application note reviews the chemical compatibility of Aramus™ assemblies with dimethyl sulfoxide (DMSO), which is commonly used as a cryopreservant in the cell and gene therapy (CGT) markets.
-
Aramus Single-Use Bag Assemblies For Cryogenic Temperature Compatibility
6/2/2021
This application note explores the cryogenic temperature compatibility of the Aramus™ bag assembly material through freezing and drop testing after 24-hour minimum immersion in the liquid nitrogen (LN2) vapor phase.
-
Transforming Your Bioanalytical Operations
5/19/2021
A combination of controlled, compliant workflow execution and dramatically streamlined data acquisition is the next phase of innovation within bioanalysis.
-
Liquid Nitrogen-Free Cryopreservation For Sustainability
4/5/2021
Discover the environmental implications of using liquid nitrogen for cell freezing, along with carbon emissions during the manufacture, transportation, and operation of LN2-free controlled-rate freezers.
-
The Science Of Cell Therapy Thawing
4/5/2021
A summary of the science of thawing following conventional slow freezing methods, the physical and biological implications of key metrics and components, and key studies from scientific literature.