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• W4280496328 abstract "Regenerative MedicineVol. 17, No. 7 EditorialFree AccessTechnology digest: the importance of reagent consistency in culturing cells for therapeutic applicationsSarah RehmanSarah Rehman*Author for correspondence: E-mail Address: s.rehman@future-science-group.comFuture Science Group, London, N3 1QB, UKSearch for more papers by this authorPublished Online:19 May 2022https://doi.org/10.2217/rme-2022-0070AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareShare onFacebookTwitterLinkedInRedditEmail Keywords: batch consistencycell culturecell manufacturingcell therapycytokineslot-to-lot variationreagent consistencyregenerative medicineserum-freexeno-freeThe field of regenerative medicine has changed considerably within the past 10 years. As the industry has expanded, a growing sophistication in primary human cell culture has revolutionized our understanding of the pathological processes in many previously untreatable diseases. As a result, the increasing research and application of stem cells has paved a way for the commercialization of cell-based therapeutics, leading to a heightened awareness around the need for specialized materials used in their manufacture.Expansion of the field has fostered multidisciplinary collaboration across academic, industrial and clinical sectors, all with the common goal of producing cells of high quality for the success of these novel therapies. To ensure high-quality and reproducible results, reagent consistency is paramount.The need for reagent consistencyThe basic requirements for growing cells in vitro are simple: the cell culture requires both a substrate to grow on and nutrients to consume. However, with the growing sophistication of cell therapy, stem cells require more specific and finely tuned medium and substrate combinations to mimic their in vivo niche [1]. This is because different stem cells often require different culture conditions, demanding more specialized and complex materials for manufacturing reagents. “Stem cells require much more effort to identify the specific nutrients, attachment proteins, growth factors and cytokines that best support their growth in culture”, said Dan Haus, formerly an application development scientist at Biological Industries (Beit HaEmek, Israel). Therefore, finely tuned reagents of high quality are essential in stem cell applications.The need for high cell quality in cell and gene therapy means that control of critical culture parameters for reproducibility is crucial. Compositional variations in cell culture reagents can result in changes in pH and salt concentrations, precipitates in solutions or unit variations for critical enzymes [2]. Inconsistencies within reagent lots – where some reagent packs differ from others – can affect the efficacy of the final cell product, leading to wasted time and effort and delayed treatment administration. Further, clinically significant variability between reagent lots can cause changes in results that pose a risk to patient care [3].Several factors can reduce the efficacy of each reagent lot. One of the most common causes of reagent inconsistency are procedural errors in the laboratory, where the user makes mistakes preparing the reagent. Beyond this, other errors can include unclear manufacturer instructions, improper storage or transport that disrupts the stability of the reagent, using reagents past their expiration date and changes in critical reagent material during manufacturing.Standardizing protocolsIt is considered both good laboratory practice as well as adhering to good laboratory regulations and accreditation standards to evaluate each new reagent lot before use [4,5], because every individual lot can affect quality control material and patient sample performance. Once specific and optimal culture conditions are established, researchers must ensure that these conditions are reproducible to be confident that they are working in identical compositions that will deliver products of high efficacy from one experiment to the next.The challenges associated with inconsistent reagents have highlighted a growing need for a standardized protocol or guideline to help laboratories ensure lot-to-lot consistency. To deal with this, the Clinical and Laboratory Standards Institute (PA, USA) published the document ‘User Evaluation of Between-Reagent Lot Variation; Approved Guideline’ in 2013 [5]. The EP26-A guidelines outline a standardized protocol that accounts for the resource constraints of the clinical laboratory, using the smallest possible patient samples.The protocol describes two main steps in ensuring consistency. The first is to establish a threshold for rejection; this is based on data that define the maximum allowance for difference between reagent lots, without having adverse impact on the final product. There should also be an appropriate statistical method applied to detect the significancy of lot-to-lot differences. The second step is to test the two reagent lots on a determined number of patient samples; this verifies the adequacy of both lots by identifying any differences in performance. The results can be analyzed in accordance with the rejection threshold. The EP26-A guidelines provide the scientific community with a standardized protocol to ensure reagent consistency, strengthening reproducibility, quality and confidence in the process.Although undergoing the necessary steps for verification of reagents is paramount in ensuring final product quality, it can be a time-consuming task for laboratories – especially when processing products in bulk. For laboratories to streamline this process, it is important to source reagents from reliable manufacturers that provide highly specified products that meet qualified standards.The role of the reagent manufacturerStudies have found that among all the sources that publish the composition of their reagents – from laboratories to manufacturers – commercial manufacturers were the most accurate in citation and formulation [2]. Producers of cell therapeutics can ensure reproducibility of culture conditions through reagent consistency. To achieve this, they must use sources of high-quality Good Manufacturing Process (GMP) reagents that are proven to be free of contaminants, are suitably qualified and display batch-to-batch consistency. Several reagent manufacturers fulfill these requirements, each seeking to provide superior performance and consistency of reagents for the benefit of the laboratory.As the field of cell and gene therapy rapidly grows, the US FDA regulatory guidelines call for greater control of raw materials. Serum-free media and reagents have been increasing in popularity over recent years; they are defined, reproducible and minimize the risk of introducing adventitious agents. “By developing fully defined cell culture reagents, product developers can help reduce this variation and improve reproducibility across multiple laboratories”, advised Justin Colacino, John G. Searle Assistant Professor of Environmental Health Sciences in the School of Public Health, University of Michigan (USA). Safety and reliability have made serum-free media and animal-free reagents an attractive target for cell and gene therapy manufacturers to deliver reproducible formulations with reduced batch-to-batch variability.For example, Sartorius (Göttingen, Germany), a biopharmaceutical manufacturing company, offers a range of serum-free and xeno-free cell culture media and reagents [6] designed and tested to provide enhanced performance and maintain consistency during cell culture, expansion and passaging. These include NutriStem media [7] for the expansion and maintenance of human stem cells (human pluripotent stem cells and human mesenchymal stem cells), 4Cell Nutri-T media [8] for the expansion and activation of immune cells, NutriFreez solutions [9] for the cryopreservation of various cells in animal-component free conditions as well as cell attachment and dissociation reagents. All products are chemically defined and vary in the range between xeno-free and serum-free to animal component free, therefore laboratories can leverage the benefits of increased safety, lot-to-lot consistency and simplified regulatory submissions.As the reagent manufacturer aims to produce reliable products to streamline success of cell and gene therapies later in the pipeline, it is important that they follow standardized guidelines to guarantee quality and consistency of products. Sartorius’ products are manufactured under current GMP conditions with a drug master file under FDA, attesting to their greatly reduced variability. This provides detailed information about the facilities and processes used in manufacturing, processing, packaging and storage of their reagents, offering an invaluable insight into the end-to-end process.Concluding remarksThe rapidly expanding commercialization of cell and gene therapy requires consistency in all areas, from laboratory protocols to the manufacture of reagents. To ensure quality and reproducibility of results, a well-informed approach must be taken when verifying lot-to-lot consistency and choosing a trusted reagent manufacturer. It is not only the laboratory’s but also the manufacturer’s responsibility to follow standardized guidelines for overall consistent results across the industry.Sponsorship & disclaimerThis feature has been brought to you in association with Sartorius. The article has been drawn from the discussions from a Technology Digest article published in RegMedNet. The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Future Science Group.Financial & competing interests disclosureS Rehman is an employee of Future Science Group and Editor of RegMedNet. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.References1. Zakrzewski W, Dobrzyński M, Szymonowicz M et al. Stem cells: past, present, and future. Stem Cell Res. Ther. 10(68), (2019). https://doi.org/10.1186/s13287-019-1165-5Medline, Google Scholar2. Burke CN, Croxall G. Variation in composition of media and reagents used in the preparation of cell cultures from human and other animal tissues: Dulbecco’s, Earle’s, and Hanks’ balanced salt solutions. In Vitro 19, 693–698 (1983).Crossref, Medline, CAS, Google Scholar3. Thompson S, Chesher D. Lot-to-lot variation. Clin. Biochem. Rev. 39(2), 51–60 (2018).Medline, Google Scholar4. Algeciras-Schimnich A. Tackling reagent lot-to-lot verification in the clinical laboratory. Clin. Laboratory News. (2014). www.aacc.org/cln/articles/2014/july/bench-mattersGoogle Scholar5. Person N. B, Budd J. R, De Vore K et al. User evaluation of between-reagent lot variation; approved guideline. CLSI document EP26-A. Clinical and Laboratory Standards Institute, PA, USA (2013).Google Scholar6. Stem Cell Culture Media and Reagents. www.sartorius.com/en/products/cell-culture-media-buffers/stem-cell-media-reagentsGoogle Scholar7. NutriStem® XF Media. NutriStem - Google ScholarGoogle Scholar8. 4Cell® Nutri-T Medium. www.sartorius.com/shop/ww/en/gbp/applications-laboratory-cell-culture/4cell-nutri-t-medium/p/05-11F2001-1KGoogle Scholar9. NutriFreez® Cryopreservation Solutions. www.sartorius.com/shop/ww/en/gbp/applications-laboratory-cell-culture-nutrifreez%C2%AE-cryopreservation-solutions/c/M_NutriFreez_Cryopreservation_MediaGoogle ScholarFiguresReferencesRelatedDetails Vol. 17, No. 7 STAY CONNECTED Metrics History Received 26 April 2022 Accepted 26 April 2022 Published online 19 May 2022 Published in print July 2022 Information© 2022 Future Medicine LtdKeywordsbatch consistencycell culturecell manufacturingcell therapycytokineslot-to-lot variationreagent consistencyregenerative medicineserum-freexeno-freeSponsorship & disclaimerThis feature has been brought to you in association with Sartorius. The article has been drawn from the discussions from a Technology Digest article published in RegMedNet. The opinions expressed in this feature are those of the author and do not necessarily reflect the views of Future Science Group.Financial & competing interests disclosureS Rehman is an employee of Future Science Group and Editor of RegMedNet. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.No writing assistance was utilized in the production of this manuscript.PDF download" @default.
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