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When considering the use of primary cells, life science researchers often request information to help them solidify their cell biology plans. The following frequently asked questions, and their answers, can help clarify the path ahead for scientists from academic universities and research institutes, as well as pharmaceutical, biotechnology and consumer health companies by Daniel Schroen, PhD, Vice President, Cell Applications, Inc. Question: What makes primary cells & their paired, optimized media different? Answer: Primary cells, isol
When considering the use of primary cells, life science researchers often request information to help them solidify their cell biology plans. The following frequently asked questions, and their answers, can help clarify the path ahead for scientists from academic universities and research institutes, as well as pharmaceutical, biotechnology and consumer health companies
by Daniel Schroen, PhD, Vice President, Cell Applications, Inc.
Question: What makes primary cells & their paired, optimized media different? Answer: Primary cells, isolated directly from fresh tissue, stand out from standard immortalized cell lines or mass-produced, general-use media (non-optimized for individual cell types). Primary cells are physiologically relevant, but notoriously finicky to isolate and culture, and our PhD staff have honed the craft for each unique tissue, species and cell type.
Question: What are potential downsides of using cell lines compared to primary cells? Answer: Mass-produced, multi-purpose media like DMEM and RPMI, and immortalized cell lines (HeLa, HEK 293, MCF-7, CACO-2, JURKAT, U937, CHO, COS-7, etc.) definitely have an important place in life science research. However, for particular applications and research intentions, they can be associated with false-positives & -negatives, sub-optimal cell/media pairing, poor cell growth, and erroneous data due to genetic alterations inherent to cell lines.
Question: We isolate primary cells ourselves in our lab. What's wrong with that? Answer: When it comes to primary cell isolation, we applaud your tenacity and do-it-yourself spirit. Like you, many of us here at Cell Applications began our research careers in the lab preparing cells with a variety of available techniques and materials. However appropriate our goals, we found these non-standardized protocols differed substantially, depending on the person, protocol, laboratory, materials, reagents, cell culture plastic, even lab/water bath temperature, humidity, time of year and HVAC system! These variables too often resulted in data inconsistencies, unexpected costs, repeats and project delays.
Question: Why buy cells isolated by Cell Applications, when lab staff can do it? Answer: After unsuccessful attempts to do it themselves, we have seen first-hand, university/research institutes and pharma/biotech outfits saving tens to hundreds of thousands of dollars, over time. They achieved this efficiency and profitability using tested, qualified, rigorously characterized CAI cells & media, versus unstandardized approaches that impose great risk for inconsistency, repeats, invalid results, false positives/negatives, etc., all with substantial personnel costs.
Question: Why are primary cells & optimized media sometimes priced higher? Answer: The pricing for meticulously-isolated, physiologically-relevant primary cells and small-batch specialty media are relatively insignificant compared to do-it-yourself primary cell isolation. The latter is associated with not-so-uncommon phenotypic inconsistencies, contamination, poor growth, unwanted cell types in the isolate and cell death due to improper technique and non-optimized media. Likewise, general-use cell lines and multi-purpose media can result in questionable data or false leads.
Question: You keep mentioning "QC" & "SOPs." Is that important? Answer: Definitely! Cell Applications expends significant resources to ensure quality, consistency, and reliability in our cells and media, benefits passed on to the researcher. Our cells & media are produced via tight Standard Operating Procedures and go through rigorous Quality Control, testing and certification, so the procedures and product remains consistent.
What kind of regulatory oversight is present at Cell Applications?
CAI?s management system is certified with regard to FDA 21 CFR Part 820, Current Good Manufacturing Practice for Medical Devices, pertaining to the manufacturing and packaging of human and animal cell culture media. Also CAI's administration systems have been assessed and approved to the ISO 9001:2008 management systems, standards and guidelines, applying to the manufacture and supply of human and animal cells and related products for research use.
Question: Don't all life science companies have certification documents on wall? Answer: Not all companies undergo independent, outside assessment to verify product quality and procedural soundness. As such, they may lack adequate training, product trace-ability, temperature regulation, aseptic technique or root-cause analysis / corrective action plan for any problems that might arise. Certifications demonstrate CAI?s commitment to product quality and customer requirements, with increased emphasis in supporting R&D programs in pharmaceutical, biotechnology and consumer product industries, in addition to academic, government and research institutes.
Question: What's involved in a quality audit? Answer: Independent third parties conduct regular audits at the Cell Applications headquarters in San Diego, CA to assess conformance to numerous standards, including records, statistical techniques, and controls for process, design, production, labeling, packaging, documentation and purchasing. They report on our activities for product identification, trace-ability, acceptance, handling, storage, and distribution. Corrective and preventive actions for nonconforming products are also examined.
Question: Our company makes equipment for cells. Can Cell Applications help us increase sales? Answer: Customers often request advice and recommendations for using primary cells on plate handlers, liquid dispensers, bioprinters, imagers, microscopes, incubators, and other devices. Capital equipment manufacturers routinely express interest in collaboration with CAI to leverage our primary cells with their platforms. Here the focus is on new, novel, more effective approaches with effectively-paired equipment and cells. Upon testing and asserting that CAI products work successfully on a platform, such a company will be in a strong position to offer customers a powerful, comprehensive equipment/consumable package already known to work when used as specified. This provides assurance to researchers, and takes a lot of protocol development and pre-assessment work off their hands, freeing them up sooner for meaningful studies. Contact CAI for more details.
Question: How can a partnership between an equipment company and CAI improve effectiveness & revenue? Answer: Combining efforts can revolutionize disruptive new technologies with certified primary cell-based techniques, applicable across big pharma, biotechnology, top research institutes and leading universities. This collaborative approach significantly enhances an equipment company's revenue generation potential, importantly through enhanced customer support, approval, retention, and cross-recommendations. For those companies or research enterprises demonstrating motivation to test and confirm the use of CAI primary cells and optimized media on their instrumentation, we are open to, and encourage a number of different collaboration models. Such partnerships effectively and reliably accelerate R&D and production programs forward, increasing the likelihood of mutual success by focusing on respective competencies. Co-marketing and co-promotion opportunities also arise.
Visit www.cellapplications.com for further information on primary cells, media & reagents, and cell biology products.