Downstream Processing White Papers and Case Studies
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Air Particle Counters Resistant To Vapor Hydrogen Peroxide (VHP)
The use of Vaporous Hydrogen Peroxide (VHP) is commonplace in the pharmaceutical industry for disinfecting sterile manufacturing cores. Since VHP is a strong oxidizing agent it can be damaging to certain internal components in optically based air particle counting instruments. The MET ONE series of air particle counters have been specifically designed to utilize materials that will not be damaged by exposure to VHP. The testing outlined in this paper demonstrates the resistance of these components and stability of the instrument over an extended period of exposure time.
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Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
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Managing Cell-Based Potency Assays: From Development To Lifecycle Maintenance
4/24/2012
Characterization of a biological product — which includes the determination of physicochemical properties, biological activity, immunochemical properties, purity and impurities — is necessary to establish the safety and efficacy profile of a given product (ICH Q6B). By Dr. Weihong Wang, manager, Molecular and Cell Biology, Eurofins Lancaster Laboratories
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Fast Quantification Of Saliva Samples In Microplates
12/7/2012
A successful evaluation study of saliva samples in microplates using Tecan’s Infinite F50 microplate reader in combination with Tecan’s Magellan™ data analysis software, using the Saliva Quantification Kit from Greiner Bio-One for the fast detection of saliva samples.
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Sani-Tech® Ultra White Paper
6/29/2012
For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.
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Monoclonal Antibody Purification Platform Using High-Capacity Protein A And Mixed-Mode Chromatography
10/1/2016
The first step in purification of an important class of therapeutic proteins, the polyclonal or monoclonal antibodies (mAbs), is their capture from plasma or tissue culture supernatants. Protein A–based media are by far the most common class of affinity products used for this purpose.
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Removal Of Host Cell Proteins During Monoclonal Antibody Purification
Protein A chromatography is a widely used and highly successful method of purifying recombinant monoclonal antibodies. However, since Protein A has high affinity for antibodies, harsh conditions such as low pH are often required to elute monoclonal antibodies from Protein A affinity columns. By 3M Purification Inc
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A Purification Strategy For Clinical-Grade Monoclonal Antibody
10/3/2016
mAbs are currently the most important class of therapeutic proteins. Advances in upstream process technologies have led to tremendous improvement of mAb titers in mammalian cell culture.
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Biomanufacturing Flexibility
12/22/2011
This white paper from BIO-G looks at how to create flexible, agile manufacturing facilities to respond to the current glut of biomanufacturing capacity and industry consolidation. Future proofing these facilities for higher titers and multiple product lines is also explored.
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Rapid Chemically-Defined Feed Media Development to Improve Simulated Cell Culture Processes
Implementing an optimized feed medium may be the most effective alternative for modifications to the growth medium in an existing process.