RMC Pharmaceutical Solutions Blog

tag:blogger.com,1999:blog-2759816029658763822Fri, 20 Mar 2026 07:11:22 +0000consultantbiotechnologybiosafetyvirusrisk assessmentanimal derived materialsviral inactivationICH Q5Acontaminationpharmaceutical expertsbovine serumgamma irradiationcell substratesprocess developmentprocess validation1993 Points to ConsiderQbDpharmaceuticalquality controlriskICH Q8MMVcharacterizationporcine circovirusprocess characterizationrapid detection methodsscale upvirus inactivationQuality by DesignbacteriophagechromatographySV40clearance studiesfermentation9CFR testingClearanceFDAGMPICH Q9USPUVCanalytical methodscache valley viruscell linesmaster cell bankmycoplasmaprocess engineering9CFRADM programEMEAFMEAPCV1Quality assuranceanimal cellsauditfiltrationhigh temperature short timeidentity testinvestigationsmass transfermixingoutsourcingretrovirusvesivirusADMsBSEBuffer preparationDesign of ExperimentsGLPISPEKT analysisPharmEurRMCTSEanniversary pharmaceutical expertsauthenticationbindingbovine polyoma viruscompendial methodscontractingdecision analysisdissolutionimpurityisolate 2117method validationoversightpharmaceutical sciencesprocess variabilityresolutionspecificationstechnology transferthermodynamicstrainingvirus. EHDV1997 Points to ConsiderAAPSAPIBVDVCAPACMOCost of GoodsDOEEndotoxinHETPHTSTICH Q5DICH QFISO 17025InterphexMycobacteriaPDAPEDVPharmaceutical FacilityUSP 63USP 85Z540.1acsbacterial retentionbottleneckbranded drugscalf serumcalibrationcalibration standardcapability indexcareers in chemistrycollaborationscombination productcoronaviruscorrosiondevicedispersiondissolved oxygendownstream processingefficacyentry levelenzymesfault tree analysisformulationgenericgeneric drugsharmonizationheat inactivationimpellerinductioninnovatorinternetisoenzymesknowledge managementmad cow diseasemembrane chromatographynational chemistry weekoccurrencepatent expirypharmaceuticalspharmacodynamicspharmacyphotosensitizerplate heightpolysorbatepreclinicalprionprotein aggregationprotein separationquality agreementrefrigerated conditionsrelative humidityriboflavin/UVAsimulated moving bedstabilitysterile filtrationtangential flow filtrationtolerancetransition analysisvariabilityvirtual companywater for injectionRMC Pharmaceutical Solutions Bloghttp://rmcpharmanews.blogspot.com/noreply@blogger.com (Scott Rudge)Blogger80125tag:blogger.com,1999:blog-2759816029658763822.post-5616955317606021849Tue, 30 May 2017 03:44:00 +00002017-05-29T21:44:03.863-06:00Push Notification Programs Monitor Your Equipment So You Don’t Have ToBy Korben Knudson Push notifications deliver information to the end user in real time.  Since no active thinking is required to receive information in this format, the recipient may focus on other tasks at hand.  This enables push notifications to be a more efficient method of receiving information, provided you’re selective when choosing the information you want pushed.  To http://rmcpharmanews.blogspot.com/2017/05/push-notification-programs-monitor-your.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-5967120563943050045Mon, 17 Mar 2014 22:20:00 +00002014-03-17T16:34:22.634-06:00Clearanceconsultantcoronavirusheat inactivationPEDVviral inactivationModeling of the Heat Inactivation of the Coronavirus Porcine Epidemic Diarrhea Virusby Dr. Ray Nims     <!--[if gte mso 9]> Normal 0 false false false EN-US JA X-NONE http://rmcpharmanews.blogspot.com/2012/09/calibration-tolerance.htmlnoreply@blogger.com (Scott Rudge)3tag:blogger.com,1999:blog-2759816029658763822.post-6945600686053506458Mon, 18 Jun 2012 18:51:00 +00002012-06-18T12:51:30.351-06:00animal derived materialsbacteriophagebiosafetybiotechnologycell substratesclearance studiesconsultantfermentationICH Q5Aprocess characterizationvirusViral clearance studies …. are they needed for proteins produced using bacterial or yeast fermentation processes? Dr. Ray Nims In E. coli or Pichia pastoris-based bioproduction of recombinant proteins, there are no suitable host cells for amplification of viruses that are infectious for humans. Bacteria such as E. coli and yeast such as P. pastoris can only support the growth of certain bacteriophage or yeast viruses, respectively. These types of viruses are not infectious for humans or animals. The http://rmcpharmanews.blogspot.com/2012/06/viral-clearance-studies-are-they-needed.htmlnoreply@blogger.com (Scott Rudge)4tag:blogger.com,1999:blog-2759816029658763822.post-4325346287783915389Thu, 24 May 2012 19:45:00 +00002012-05-24T13:45:38.736-06:001993 Points to ConsiderBSEcell linescharacterizationClearanceclearance studiesconsultantICH Q5Aprocess characterizationviral inactivationUpdate: New USP General Chapter 1050.1 By Dr. Ray Nims There is a new general chapter being prepared for inclusion in the United States Pharmacopeia (USP). It will be entitled “Design, Evaluation, and Characterization of Viral Clearance Procedures” and will be numbered 1050.1 to associate it with the current General Chapter <1050>. A little history is called for to make this association more clear. Chapter <1050> http://rmcpharmanews.blogspot.com/2012/05/update-new-usp-general-chapter-10501.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-583856802461640938Tue, 01 May 2012 14:54:00 +00002012-05-01T08:56:22.187-06:00consultantICH QFpharmaceutical expertsrefrigerated conditionsrelative humiditystabilityRelative Humidity Specification at Refrigerated Conditions By Dr. Scott Rudge The ICH has established well known temperature and humidity standards for conducting stability studies that mimic the environments in various parts of the world.  Zones I and II correspond to cold and temperate areas respectively, such as North America and Europe, while Zones III and IV correspond to hot and dry or hot and humid climates, like Equatorial Africa, Brazilhttp://rmcpharmanews.blogspot.com/2012/05/relative-humidity-specification-at.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-2097341736252976871Thu, 15 Mar 2012 21:00:00 +00002012-03-27T10:55:53.819-06:00biotechnologybottleneckchromatographyconsultantdownstream processingprotein separationsimulated moving bedMoving Past the BottleneckBy Dr. Scott Rudge Is 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.  Without a doubt, chromatography is slow and inefficient. A typical protein loading for commercial scale chromatography is 25 to 40 g/L, and a typical cycle is on the order of 8 http://rmcpharmanews.blogspot.com/2012/03/moving-past-bottleneck.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-5773084240688943756Mon, 13 Feb 2012 23:11:00 +00002012-03-27T11:17:20.413-06:00biotechnologybovine polyoma virusbovine serumconsultantcontaminationgamma irradiationhigh temperature short timeisolate 2117MMVPCV1SV40UVCvirus inactivationUV-C versus small, non-enveloped viruses By Dr. Ray Nims Small, non-enveloped viruses (especially the circoviruses, parvoviruses, picornaviruses, caliciviruses, and polyomaviruses) and bacteriophage with similar characteristics represent a special challenge to the biologics industry. In fact, contamination events have occurred with each of these virus families; in some cases more than once. Within the Circoviridae, the primary http://rmcpharmanews.blogspot.com/2012/02/uv-c-versus-small-non-enveloped-viruses.htmlnoreply@blogger.com (Scott Rudge)1tag:blogger.com,1999:blog-2759816029658763822.post-7448554885836704488Tue, 31 Jan 2012 19:13:00 +00002012-01-31T12:13:55.000-07:00analytical methodsbindingchromatographyconsultantmembrane chromatographyprocess developmentprocess engineeringscale upIs Membrane Chromatography the Answer?by Dr. Scott Rudge Membrane 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 processing?  Was Allen Iverson the answer to the Nugget’s basketball dilemma?  I’m still skeptical. The idea to add ligand functionality to membranes was not new at the time, http://rmcpharmanews.blogspot.com/2012/01/is-membrane-chromatography-answer.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-7064798969364341891Thu, 05 Jan 2012 23:20:00 +00002012-01-12T16:43:30.278-07:00bacteriophagebiotechnologyconsultantidentity testinvestigationsrapid detection methodsvirusAssessing rapid viral enumeration/detection systems By Dr. Ray Nims In 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, should greatly expedite the quantification and identification of viruses (and bacteriophage) as compared with the existing cell culture-based approaches. Rapid enumeration http://rmcpharmanews.blogspot.com/2012/01/assessing-rapid-viral.htmlnoreply@blogger.com (Scott Rudge)1tag:blogger.com,1999:blog-2759816029658763822.post-5555570116562990467Thu, 10 Nov 2011 17:53:00 +00002012-03-28T12:13:56.092-06:00animal derived materialsbiosafetyClearanceconsultantgamma irradiationporcine circovirusUVCvirus inactivationThe inactivation literature for circovirusesby Dr. Ray Nims The 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 of biologicals due to the difficulty of eradicating the viruses from raw materials or from a contaminated facility.  At 17-25 nm particle size, the circoviruses are among the smallest of the http://rmcpharmanews.blogspot.com/2011/11/inactivation-literature-for.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-5253602831461457692Fri, 28 Oct 2011 18:39:00 +00002011-11-08T10:17:57.876-07:001993 Points to Consider9CFR testingADM programbiotechnologycell linescharacterizationconsultantporcine circovirusrapid detection methodsvirusPorcine circoviruses, vaccines, and trypsin By Dr. Ray Nims It 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 presence of the PCV viral sequences was, in both cases, provisionally attributed to the use of porcine trypsin during the culture of the cell substrates used in the manufacture of the vaccines. http://rmcpharmanews.blogspot.com/2011/10/porcine-circoviruses-vaccines-and.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-613405583485355104Wed, 12 Oct 2011 14:50:00 +00002011-10-12T08:50:39.509-06:00animal derived materialsbacteriophagebiosafetybovine serumconsultantgamma irradiationriskSV40viral inactivationRidding serum of viruses with gamma irradiation: part 2by Dr. Ray Nims In 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 irradiation is a commonly employed risk mitigation strategy for biopharmaceutical manufacture, and indeed the European Agency for the Evaluation of Medicinal Products in its Note for guidance on http://rmcpharmanews.blogspot.com/2011/10/ridding-serum-of-viruses-with-gamma.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-952523523391492089Wed, 28 Sep 2011 20:10:00 +00002011-09-30T17:05:12.010-06:00chromatographyconsultantHETPICH Q8process engineeringprocess variabilityQbDtransition analysisIs Your Chromatography in Control, or in Transition? By Dr. Scott Rudge While 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 your valuable molecule, and insufferable companion impurities, onto the column, there is little that you can do to affect the purification outcome that waits you some minutes to hours later. http://rmcpharmanews.blogspot.com/2011/09/is-your-chromatography-in-control-or-in.htmlnoreply@blogger.com (Scott Rudge)1Longmont, CO, USA40.1672068 -105.101927540.1186713 -105.1808915 40.2157423 -105.0229635tag:blogger.com,1999:blog-2759816029658763822.post-4416745405799422919Thu, 22 Sep 2011 18:52:00 +00002011-11-11T12:55:30.569-07:00animal cellsbiosafetybiotechnologycell substratescharacterizationconsultantvirusA much improved Ph. Eur. Chapter 5.3.2 By Dr. Ray Nims Vaccine 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 for human use. This chapter addresses the characterization of vaccine cell substrates. The section on Test Methods for Cell Cultures within the chapter includes an instruction to perform a http://rmcpharmanews.blogspot.com/2011/09/much-improved-ph-eur-chapter-532.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-578338998185914009Mon, 12 Sep 2011 20:25:00 +00002011-09-12T14:25:20.925-06:00animal derived materialsbiosafetybovine serumcache valley virusconsultantgamma irradiationMMVporcine circovirusrisk assessmentSV40vesivirusviral inactivationRidding serum of viruses with gamma irradiation: part 1by Dr. Ray Nims Blood 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, REO virus, vesivirus, and epizootic hemorrhagic disease virusinto a biological product. If animal serum must be used in upstream manufacturing processes, the risk of introducing a virus may be http://rmcpharmanews.blogspot.com/2011/09/ridding-serum-of-viruses-with-gamma.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-2265733478304626769Fri, 26 Aug 2011 17:49:00 +00002011-08-26T11:49:30.831-06:00analytical methodsconsultantimpuritymethod validationprocess characterizationquality controlOur 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, NS0, E. coli, etc.) used in the manufacture of a biologic. Host cell protein is considered to be a process-related impurity/contaminant. The most typical approach to quantitation of residualhttp://rmcpharmanews.blogspot.com/2011/08/our-take-on-process-specific-vs-generic.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-2315529046143827411Mon, 25 Jul 2011 23:38:00 +00002011-07-25T17:39:40.107-06:00analytical methodsbiosafetycache valley virusconsultantinvestigationsquality controlrapid detection methodsvirusRapid Identification of Viral Contaminants, FinallyBy 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 sample. The identification process took this long because it involved what I have referred to as the “shotgun approach”, or it involved luck. Let’s start with luck. That is probably the wrong http://rmcpharmanews.blogspot.com/2011/07/rapid-identification-of-viral.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-1874074635024409826Sun, 10 Jul 2011 05:31:00 +00002011-07-09T23:31:08.440-06:00CAPAconsultantdecision analysisfault tree analysisQuality assurancerisk assessmentCan You Decide on CAPA?By Dr. Scott Rudge When 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 in ways too numerous to list in this blog.  It can be surmised that the failure mode was not anticipated, so the manufacturer is wise to determine the cause of the failure, correct ithttp://rmcpharmanews.blogspot.com/2011/07/can-you-decide-on-capa.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-8817770935945202704Fri, 10 Jun 2011 22:46:00 +00002011-06-10T16:46:05.413-06:009CFR testinganimal derived materialsbacteriophagebiosafetybovine serumcell substratesconsultantfermentationgamma irradiationMMVporcine circovirusvirusSmall, non-enveloped viruses: number 1 threat to biologics manufactureby Dr. Ray Nims Perhaps 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 of contaminating viruses has included some relatively large enveloped and non-enveloped viruses (Reovirus type 2, epizootic hemorrhagic disease virus, Cache Valley virus, human adenovirus), by http://rmcpharmanews.blogspot.com/2011/06/small-non-enveloped-viruses-number-1.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-8016249981694651360Tue, 31 May 2011 22:42:00 +00002011-05-31T16:42:29.522-06:00biotechnologyconsultantDesign of Experimentsfermentationmass transfermixingpharmaceutical sciencesprocess engineeringprocess validationscale uptechnology transferThe Art of Bioreactor/Fermenter Scale-Up (or Scale-Down)by Dr. Deb Quick Effective bioreactor or fermenter scale-up/down is essential for successful bioprocessing. During development, small scale systems are employed to quickly evaluate and optimize the process, but larger scale systems are necessary for producing commercial quantities at a reasonable cost. But how does one effectively transfer the process between scales so that the process performs http://rmcpharmanews.blogspot.com/2011/05/art-of-bioreactorfermenter-scale-up-or.htmlnoreply@blogger.com (Scott Rudge)0tag:blogger.com,1999:blog-2759816029658763822.post-3682254064679534676Fri, 06 May 2011 17:27:00 +00002011-05-06T12:05:16.780-06:00consultantfiltrationprocess engineeringscale uptangential flow filtrationTFF Under PressureBy Dr. Scott Rudge Are 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 simple buffer exchange, this is warranted.  However, forewarned is forearmed when scale up is concerned. Primarily, there is just one scale up issue with cross flow filtration, and that is http://rmcpharmanews.blogspot.com/2011/05/tff-under-pressure.htmlnoreply@blogger.com (Scott Rudge)0Longmont, CO, USA40.1672068 -105.1019274999999940.125207800000005 -105.18245999999999 40.2092058 -105.02139499999998