tag:blogger.com,1999:blog-27598160296587638222024-03-14T03:24:01.202-06:00RMC Pharmaceutical Solutions BlogScott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.comBlogger80125tag:blogger.com,1999:blog-2759816029658763822.post-56169553176060218492017-05-29T21:44:00.000-06:002017-05-29T21:44:03.863-06:00Push 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-59671205639430500452014-03-17T16:20:00.000-06:002014-03-17T16:34:22.634-06:00Modeling of the Heat Inactivation of the Coronavirus Porcine Epidemic Diarrhea Virusby Dr. Ray Nims
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Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-87120453382245425042014-01-09T16:04:00.001-07:002014-01-09T16:04:10.344-07:00 Modeling of Inactivation vs. Temperature for Interpreting HTST results
by Dr. Ray Nims
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Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com1tag:blogger.com,1999:blog-2759816029658763822.post-77425408068434265332013-01-09T09:58:00.001-07:002013-01-09T09:58:30.528-07:00BVDV in commercial bovine serum...still?by Dr. Ray Nims
One of the animal-derived materials (ADM) most commonly utilized for cell culture and for production of biologicals manufactured using cell cultures is bovine serum (most typically calf serum or fetal bovine serum). There is an inherent risk of introduction of adventitious contaminants (viruses and molllicutes) associated with the use of culture media containing serum. In Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-51095537281560434792012-12-10T14:04:00.002-07:002012-12-10T14:06:10.492-07:00The Cost of Pharmaceutical Facilities<!--[if !mso]>
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Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-49823757006056241652012-09-13T13:21:00.003-06:002012-09-14T10:03:00.849-06:00Calibration Tolerance<!--[if !mso]>
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Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com3tag:blogger.com,1999:blog-2759816029658763822.post-69456006860535064582012-06-18T12:51:00.002-06:002012-06-18T12:51:30.351-06:00Viral 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com4tag:blogger.com,1999:blog-2759816029658763822.post-43253462877839153892012-05-24T13:45:00.001-06:002012-05-24T13:45:38.736-06:00Update: 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> Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-5838568024616409382012-05-01T08:54:00.000-06:002012-05-01T08:56:22.187-06:00Relative 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, BrazilScott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-20973417362529768712012-03-15T15:00:00.000-06:002012-03-27T10:55:53.819-06:00Moving 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-57730842406889437562012-02-13T16:11:00.000-07:002012-03-27T11:17:20.413-06:00UV-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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com1tag:blogger.com,1999:blog-2759816029658763822.post-74485548858367044882012-01-31T12:13:00.000-07:002012-01-31T12:13:55.000-07:00Is 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, Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-70647989693643418912012-01-05T16:20:00.000-07:002012-01-12T16:43:30.278-07:00Assessing 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com1tag:blogger.com,1999:blog-2759816029658763822.post-55555701165629904672011-11-10T10:53:00.001-07:002012-03-28T12:13:56.092-06:00The 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-52536028314614576922011-10-28T12:39:00.000-06:002011-11-08T10:17:57.876-07:00Porcine 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. Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-6134055834853551042011-10-12T08:50:00.000-06:002011-10-12T08:50:39.509-06:00Ridding 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-9525235233914920892011-09-28T14:10:00.000-06:002011-09-30T17:05:12.010-06:00Is 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.
Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com1Longmont, CO, USA40.1672068 -105.101927540.1186713 -105.1808915 40.2157423 -105.0229635tag:blogger.com,1999:blog-2759816029658763822.post-44167454057994229192011-09-22T12:52:00.000-06:002011-11-11T12:55:30.569-07:00A 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-5783389981859140092011-09-12T14:25:00.000-06:002011-09-12T14:25:20.925-06:00Ridding 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-22657334783046267692011-08-26T11:49:00.000-06:002011-08-26T11:49:30.831-06:00Our 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 residualScott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-23155290461438274112011-07-25T17:38:00.000-06:002011-07-25T17:39:40.107-06:00Rapid 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-18740746350244098262011-07-09T23:31:00.000-06:002011-07-09T23:31:08.440-06:00Can 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 itScott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-88177709359452027042011-06-10T16:46:00.000-06:002011-06-10T16:46:05.413-06:00Small, 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-80162499816946513602011-05-31T16:42:00.000-06:002011-05-31T16:42:29.522-06:00The 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0tag:blogger.com,1999:blog-2759816029658763822.post-36822540646795346762011-05-06T11:27:00.000-06:002011-05-06T12:05:16.780-06:00TFF 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 Scott Rudgehttp://www.blogger.com/profile/18056243016391834351noreply@blogger.com0Longmont, CO, USA40.1672068 -105.1019274999999940.125207800000005 -105.18245999999999 40.2092058 -105.02139499999998