Lesson learned: Outsource but remain in control!
By Dr. Ray NimsIn a previous posting, we described the responsibilities of the contract giver (contractee) and the contract acceptor (contractor) in outsourced pharmaceutical quality control testing....
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Cold Facts About Dissolved Oxygen
By Dr. Scott RudgeWhat’s the solubility of oxygen in water? Everyone knows that the answer to this question is “low”, and that’s enough to know for many practical applications. But it’s high enough to...
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Getting a grip on prophage
by Dr. Ray NimsIn a previous post, we discussed bacteriophage as a risk for the manufacture of biopharmaceuticals by bacterial fermentation. We mentioned briefly that bacteriophage may integrate within...
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What's That in My Protein? Degraded Polysorbate Again?
By Dr. Sheri GlaubMahler, et. al. have recently published a paper in Pharmaceutical Research entitled, “The Degradation of Polysorbates 20 and 80 and its Potential Impact on the Stability of...
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TFF Under Pressure
By Dr. Scott RudgeAre there scale up issues for cross flow filtration? In general, this step is overlooked as a scale up concern, and usually, given the primarily clean feed streams encountered in...
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The Art of Bioreactor/Fermenter Scale-Up (or Scale-Down)
by Dr. Deb QuickEffective bioreactor or fermenter scale-up/down is essential for successful bioprocessing. During development, small scale systems are employed to quickly evaluate and optimize the...
View ArticleSmall, non-enveloped viruses: number 1 threat to biologics manufacture
by Dr. Ray NimsPerhaps surprisingly, few types of viruses have infected biologics manufacture since the 1980s when the first recombinant proteins began to be produced in mammalian cells. While the list...
View ArticleCan You Decide on CAPA?
By Dr. Scott RudgeWhen things go wrong in pharmaceutical manufacturing, consequences can be dire. Small changes in the quality of the pharmaceutical product can cause major consequences for patients...
View ArticleRapid Identification of Viral Contaminants, Finally
By Ray Nims, Ph.D.There was a time, not long ago, when it might take months to years to identify a viral contaminant isolated from a biological production process or from an animal or patient tissue...
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Our take on process-specific vs. generic host cell protein assays
By Drs. Ray Nims and Lori Nixon The residual host cell protein (HCP assay) is used to determine the concentration, in process streams, of protein originating from the production cell (Chinese hamster,...
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Ridding serum of viruses with gamma irradiation: part 1
by Dr. Ray NimsBlood serum, while at times required as a medium component for cell growth in vitro, is an animal-derived material that can introduce contaminating viruses such as Cache Valley virus,...
View ArticleA much improved Ph. Eur. Chapter 5.3.2
By Dr. Ray NimsVaccine manufacturers intending to market in the EU should be aware of a recent change in the European Pharmacopoeia (Ph. Eur.) chapter 5.2.3 Cell substrates for production of vaccines...
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Is Your Chromatography in Control, or in Transition?
By Dr. Scott RudgeWhile chromatography continues to be an essential tool in pharmaceutical manufacturing, it remains frustratingly opaque and resistant to feedback control of any kind. Once you load...
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Ridding serum of viruses with gamma irradiation: part 2
by Dr. Ray NimsIn a previous posting, we described the susceptibility of viruses from various families to inactivation in frozen serum treated with gamma irradiation (data from the literature). Gamma...
View ArticlePorcine circoviruses, vaccines, and trypsin
By Dr. Ray NimsIt has now been more than a year since the announcements by GlaxoSmithKline (GSK) and Merck of the presence of porcine circovirus (PCV) genomic material in their rotavirus vaccines.The...
View ArticleThe inactivation literature for circoviruses
by Dr. Ray NimsThe Circoviridae family of viruses represent an extreme case for small, non-enveloped viruses. We have posted previously that the latter group constitutes a high risk for manufacturers...
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Assessing rapid viral enumeration/detection systems
By Dr. Ray NimsIn a previous posting, we alluded to the recent availability of rapid methods for identification of viruses. These technologies, together with rapid methods for enumerating viruses,...
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Is Membrane Chromatography the Answer?
by Dr. Scott RudgeMembrane chromatography gets a fair amount of hype. It’s supposed to be faster, cheaper, it can be made disposable. But is it the real answer to the “bottleneck” in downstream...
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UV-C versus small, non-enveloped viruses
By Dr. Ray NimsSmall, non-enveloped viruses (especially the circoviruses, parvoviruses, picornaviruses, caliciviruses, and polyomaviruses) and bacteriophage with similar characteristics represent a...
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Moving Past the Bottleneck
By Dr. Scott RudgeIs there a bottleneck in Downstream Processing? The membrane chromatography vendors certainly want you to think so. The problem is in the efficiency of chromatographic purification....
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