RMC Pharmaceutical Solutions Inc.

Longmont, CO, United States

RMC Pharmaceutical Solutions Inc.

Longmont, CO, United States
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Kerr A.,BioReliance | Nims R.,BioReliance | Nims R.,RMC Pharmaceutical Solutions Inc.
PDA Journal of Pharmaceutical Science and Technology | Year: 2010

While viral safety is a major concern for biologics manufactured using mammalian cells, the numbers of viral contamination events reported in the literature are quite low. During a 10-year period during which biologics derived from a variety of mammalian cell culture processes were evaluated using the in vitro virus screening assay, only reovirus type 2 and Cache Valley virus were detected, and these only in biologics manufactured in Chinese hamster ovary (CHO) cells. From the literature, we know that the murine parvovirus mouse minute virus has also been detected in biologics manufactured using CHO cells. The manifestations of these viral contaminants within the biotech manufacturing processes are discussed, as are the likely sources of the contaminants and some possible approaches for mitigating the risk of future occurrences of these types of contamination. ©PDA, Inc. 2010.


Nims R.,RMC Pharmaceutical Solutions Inc
American Pharmaceutical Review | Year: 2015

The use of a PCR and sequencing based cytochrome c oxidase subunit 1 (CO1) barcode assay for establishing the species level identity of animal cells is discussed below. The methodology targets a semiconserved region of the mitochondrial CO1 gene for specieslevel identity testing of animal (mammalian and insect) cells. CO1 barcoding is intended as an alternative to the isoenzyme analysis assay, for which reagents are no longer commercially available. This white paper provides the opinion of a subjectmatter expert on the suitability of the CO1 barcode platform for specieslevel identity testing and as a replacement for isoenzyme analysis testing for animal cells. The following is an excerpt of a white paper published on 5th August 2015. To download the full version, and find out more about the CO1 barcode assay available at BioReliance please visit www.bioreliance.com/CO1barcode.


Nims R.W.,RMC Pharmaceutical Solutions Inc. | Gauvin G.,Amgen Inc. | Plavsic M.,Genzyme
Biologicals | Year: 2011

Animal-derived materials such as animal sera represent a low, but finite, risk for introduction of an adventitious agent (virus or mollicute) into a biological bulk harvest during upstream manufacturing processes involving mammalian cell substrates. Viral and mollicute (Mycoplasma sp. and Acholeplasma sp.) contamination events have been relatively rare, but many of those that have been reported have been attributed to use of infected animal sera in growth media during cell expansion. The risk of introduction of viruses and mollicutes may be mitigated by elimination of the use of animal sera and implementation instead of chemically defined or serum- and animal-derived material-free cell culture media. When use of animal sera is unavoidable, however, mitigation of the risk of introducing an adventitious contaminant may involve treatment of the sera to inactivate potential contaminants. Gamma irradiation is one of the most widely employed methods for viral and mollicute inactivation in animal sera. In this article, we review the inactivation results reported for viral and mollicute inactivation in frozen serum. Studies performed to assess the impact of gamma irradiation on serum quality and performance are also discussed. The available data indicate that inactivation of mollicutes in serum is essentially complete at the gamma radiation doses normally employed (25-40 kGy), while the efficacy and kinetics for viral inactivation in serum by gamma irradiation appear to be dependent in part upon the size of the target virus. © 2011 The International Alliance for Biological Standardization.


Barallon R.,LCG Group | Bauer S.R.,Center for Biologics Evaluation and Research | Butler J.,U.S. National Institute of Standards and Technology | Capes-Davis A.,Childrens Medical Research Institute | And 20 more authors.
In Vitro Cellular and Developmental Biology - Animal | Year: 2010

Cell misidentification and cross-contamination have plagued biomedical research for as long as cells have been employed as research tools. Examples of misidentified cell lines continue to surface to this day. Efforts to eradicate the problem by raising awareness of the issue and by asking scientists voluntarily to take appropriate actions have not been successful. Unambiguous cell authentication is an essential step in the scientific process and should be an inherent consideration during peer review of papers submitted for publication or during review of grants submitted for funding. In order to facilitate proper identity testing, accurate, reliable, inexpensive, and standardized methods for authentication of cells and cell lines must be made available. To this end, an international team of scientists is, at this time, preparing a consensus standard on the authentication of human cells using short tandem repeat (STR) profiling. This standard, which will be submitted for review and approval as an American National Standard by the American National Standards Institute, will provide investigators guidance on the use of STR profiling for authenticating human cell lines. Such guidance will include methodological detail on the preparation of the DNA sample, the appropriate numbers and types of loci to be evaluated, and the interpretation and quality control of the results. Associated with the standard itself will be the establishment and maintenance of a public STR profile database under the auspices of the National Center for Biotechnology Information. The consensus standard is anticipated to be adopted by granting agencies and scientific journals as appropriate methodology for authenticating human cell lines, stem cells, and tissues. © 2010 The Author(s).


Nims R.W.,RMC Pharmaceutical Solutions Inc. | Plavsic M.,Genzyme
Journal of Microbial and Biochemical Technology | Year: 2013

A systematic review of the viral heat inactivation literature for data compatible with modeling using the decimal reduction value/z value approach as well as a new approach based on the power function relationship between decimal reduction value and inactivation temperature is presented. The review has enabled us to conduct quantitative intra-family and inter-family comparisons for various heat inactivation characteristics for viruses, including z value, temperature in°C for 1 log10 and for 4 log10 inactivation in 30 seconds. The parvoviridae family is confirmed to be the most heat resistant of the various virus families for which data were analyzed. © 2013 Nims RW, et al.


Lebrec H.,Amgen | Narayanan P.,Amgen | Nims R.,Amgen | Nims R.,RMC Pharmaceutical Solutions Inc.
Journal of Applied Toxicology | Year: 2010

Biopharmaceuticals represent significant advances in therapeutic approaches for unmet medical needs, and increasingly, traditional pharmaceutical firms have been incorporating biotechnology capabilities into their product portfolios. There are some differences in the overall safety testing paradigms for small molecules and biopharmaceuticals, this safety testing including both quality and toxicology aspects. These differences are associated with both the manufacturing processes involved and the molecules themselves. For example, for biopharmaceuticals, living cells represent the factories for synthesizing complex molecular entities. As a result of this, safety testing for this class of drugs includes adventitious agent testing (e.g. viral, mycoplasma, transmissible spongiform encephalopathy agents) not normally needed for small molecules. Also, strategies for nonclinical toxicology testing of biopharmaceuticals differ from the paradigms used for small molecules and often need to be defined on a case-by-case basis, primarily taking into consideration species cross-reactivity attributes of the molecule of interest. Certain studies required for small molecules are not applicable to most biopharmaceuticals (i.e. genotoxicity testing, testing for interactions with the hERG channel). This manuscript provides an overviewof both the quality and nonclinical toxicology testing for these mammalian-cell-derived products, two elements pivotal to the overall nonclinical assessment of the safety of these biopharmaceutical products. Copyright © 2010 John Wiley & Sons, Ltd.


Nims R.W.,RMC Pharmaceutical Solutions Inc. | Meyers E.,Amgen
BioPharm International | Year: 2010

The United States Pharmacopeia has recently published chapter <63> Mycoplasma Tests. Biopharmaceutical companies conducting mycoplasma testing as a lot release assay for unprocessed bulk material will need to comply with this new regulation once it becomes effective later this year. In this article, we compare the language of USP <63> to that of the existing regulation (European Pharmacopoeia chapter 2.6.7 Mycoplasmas) and guidance (1993 Points to Consider in the Characterization of Cell Lines used to Produce Biologics).


Kerrigan L.,10801 University Blvd | Nims R.W.,RMC Pharmaceutical Solutions Inc.
Regenerative Medicine | Year: 2011

Authentication of human tissues, cell lines and primary cell cultures (including stem cell preparations) used as therapeutic modalities is often performed using phenotyping and technologies capable of assessing identity to the species level (e.g., isoenzyme analysis and/or karyotyping). This authentication paradigm alone cannot provide assurance that the correct human cell preparation is administered, so careful labeling and tracking of cells from the donor, during manufacture and as part of the final product are also employed. Precise, accurate identification of human cells to the individual donor level could, however, significantly reduce the risks of exposing human subjects to misidentified cells. The availability of a standardized method for achieving this will provide a way to improve the safety profile of human cell-based products by providing assurance that a given lot of cells originated from the intended donor and were not inadvertently mixed or replaced with cells from other donors. In support of this goal, an international team of scientists has prepared a consensus standard on authentication of human cells using short tandem repeat profiling. Associated with the standard itself will be the establishment and maintenance of a public database of short tandem repeat profiles for commonly used cell lines. © 2011 Future Medicine Ltd.


Nims R.W.,RMC Pharmaceutical Solutions Inc | Sykes G.,10801 University Blvd | Cottrill K.,10801 University Blvd | Ikonomi P.,10801 University Blvd
In Vitro Cellular and Developmental Biology - Animal | Year: 2010

The role of cell authentication in biomedical science has received considerable attention, especially within the past decade. This quality control attribute is now beginning to be given the emphasis it deserves by granting agencies and by scientific journals. Short tandem repeat (STR) profiling, one of a few DNA profiling technologies now available, is being proposed for routine identification (authentication) of human cell lines, stem cells, and tissues. The advantage of this technique over methods such as isoenzyme analysis, karyotyping, human leukocyte antigen typing, etc., is that STR profiling can establish identity to the individual level, provided that the appropriate number and types of loci are evaluated. To best employ this technology, a standardized protocol and a data-driven, quality-controlled, and publically searchable database will be necessary. This public STR database (currently under development) will enable investigators to rapidly authenticate human-based cultures to the individual from whom the cells were sourced. Use of similar approaches for non-human animal cells will require developing other suitable loci sets. While implementing STR analysis on a more routine basis should significantly reduce the frequency of cell misidentification, additional technologies may be needed as part of an overall authentication paradigm. For instance, isoenzyme analysis, PCR-based DNA amplification, and sequence-based barcoding methods enable rapid confirmation of a cell line's species of origin while screening against cross-contaminations, especially when the cells present are not recognized by the species-specific STR method. Karyotyping may also be needed as a supporting tool during establishment of an STR database. Finally, good cell culture practices must always remain a major component of any effort to reduce the frequency of cell misidentification. © 2010 The Author(s).


PubMed | RMC Pharmaceutical Solutions Inc.
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2011

Animal-derived materials such as animal sera represent a low, but finite, risk for introduction of an adventitious agent (virus or mollicute) into a biological bulk harvest during upstream manufacturing processes involving mammalian cell substrates. Viral and mollicute (Mycoplasma sp. and Acholeplasma sp.) contamination events have been relatively rare, but many of those that have been reported have been attributed to use of infected animal sera in growth media during cell expansion. The risk of introduction of viruses and mollicutes may be mitigated by elimination of the use of animal sera and implementation instead of chemically defined or serum- and animal-derived material-free cell culture media. When use of animal sera is unavoidable, however, mitigation of the risk of introducing an adventitious contaminant may involve treatment of the sera to inactivate potential contaminants. Gamma irradiation is one of the most widely employed methods for viral and mollicute inactivation in animal sera. In this article, we review the inactivation results reported for viral and mollicute inactivation in frozen serum. Studies performed to assess the impact of gamma irradiation on serum quality and performance are also discussed. The available data indicate that inactivation of mollicutes in serum is essentially complete at the gamma radiation doses normally employed (25-40kGy), while the efficacy and kinetics for viral inactivation in serum by gamma irradiation appear to be dependent in part upon the size of the target virus.

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