Longitudinal characterization of TK6 cells sequentially adapted to animal product-free, chemically defined culture medium: considerations for genotoxicity studies.

Article

作者: Scott, Andrew ; Kelsall, Joanne ; Fu, Jianan ; Millar, Val ; Hutter, Victoria ; Elloway, Joanne ; Ebner, Daniel ; Woods, Ian ; Perez-Diaz, Noelia ; Cruickshank, Rebecca ; Hoffman, Ewelina ; Doherty, Ann ; Clements, Julie ; Saib, Ouarda

Introduction: In vitro approaches are an essential tool in screening for toxicity of new chemicals, products and therapeutics. To increase the reproducibility and human relevance of these in vitro assessments, it is advocated to remove animal-derived products such as foetal bovine serum (FBS) from the cell culture system. Currently, FBS is routinely used as a supplement in cell culture medium, but batch-to-batch variability may introduce inconsistency in inter- and intra-lab assessments. Several chemically defined serum replacements (CDSR) have been developed to provide an alternative to FBS, but not every cell line adapts easily and successfully to CDSR-supplemented medium, and the long-term effect on cell characteristics remains uncertain. Aim: The aim of this study was to adapt the TK6 cell line to animal-product free CDSR-supplemented medium and evaluate the long-term effects on cell health, growth, morphology, phenotype, and function. This included a provisional assessment to determine the suitability of the transitioned cell line for standardised genotoxicity testing using the "in vitro mammalian cell micronucleus test" (OECD TG 487). Materials and methods: Gradual adaptation and direct adaptation methodologies were compared by assessing the cell proliferation, size and viability every passage until the cells were fully adapted to animal-free CDSR. The metabolic activity and membrane integrity was assessed every 4-8 passages by PrestoBlue and CytoTox-ONE™ Homogeneous Membrane Integrity Assay respectively. A detailed morphology study by high content imaging was performed and the expression of cell surface markers (CD19 and CD20) was conducted via flow cytometry to assess the potential for phenotypic drift during longer term culture of TK6 in animal-free conditions. Finally, functionality of cells in the OECD TG 487 assay was evaluated. Results: The baseline characteristics of TK6 cells cultured in FBS-supplemented medium were established and variability among passages was used to set up acceptance criteria for CDSR adapted cells. TK6 were adapted to CDSR supplemented medium either via direct or gradual transition reducing from 10% v/v FBS to 0% v/v FBS. The cell growth rate was compromised in the direct adaptation and therefore the gradual adaptation was preferred to investigate the long-term effects of animal-free CDSR on TK6 cells. The new animal cells showed comparable (p > 0.05) viability and cell size as the parent FBS-supplemented cells, with the exception of growth rate. The new animal free cells showed a lag phase double the length of the original cells. Cell morphology (cellular and nuclear area, sphericity) and phenotype (CD19 and CD20 surface markers) were in line (p > 0.05) with the original cells. The new cells cultured in CDSR-supplemented medium performed satisfactory in a pilot OECD TG 487 assay with compounds not requiring metabolic activation. Conclusion: TK6 cells were successfully transitioned to FBS- and animal product-free medium. The new cell cultures were viable and mimicked the characteristics of FBS-cultured cells. The gradual transition methodology utilised in this study can also be applied to other cell lines of interest. Maintaining cells in CDSR-supplemented medium eliminates variability from FBS, which in turn is likely to increase the reproducibility of in vitro experiments. Furthermore, removal of animal derived products from cell culture techniques is likely to increase the human relevance of in vitro methodologies.

Frontiers in Toxicology

OECD workshop consensus report: Ethical considerations with respect to human derived products, specifically human serum, in OECD test guidelines

Article

作者: Versteegen, Rosemary ; Langezaal, Ingrid ; Tonn, Torsten ; Murray, Jenny ; Jacobs, Miriam N ; Cavanagh, Kevin ; Treasure, Carol ; Fu, Jianan ; Tsukano, Masaaki ; Bult, Jan M ; Stoddart, Gilly ; Grange, Emma ; Delrue, Nathalie ; Misztela, Dominika ; Chesne, Christophe ; Paparella, Martin

The ethical needs and concerns with use and sourcing of human materials, particularly serum, in OECD in vitro test guidelines were explored in a dedicated international workshop held in 2019. The health-related aspects of the donation procedure, including tissue screening, donor health, laboratory work health protection, permission from the donor for commercial use, payment of the donors and the potential for exploitation of low-income populations and data protection of the donors; supply, availability, and competition with clinical needs; traceability of the serum and auditability/GLP needs for the Test Guideline Programme, were examined. Here we provide the recommendations of the workshop with respect to the use of human serum, and potentially other human reagents, specifically with regard to test method development for OECD Test Guideline utility as part of the Mutual Acceptance of Data requirement across all OECD member countries. These include informed donor consent terminology, a checklist of human serum information requirements to be included with the Good Laboratory Practise report, and suitable sources for human serum to ensure waste supplies are used, that can no longer be used for medical purposes, ensuring no competition of supply for essential medical use.

项与 PAN-Biotech GmbH 相关的新闻（医药）

2024-10-23

·PRNewswire

The Human Platelet Lysate market is projected to grow by USD 0.011 Million from 2024-2028, driven by AI and the rising prevalence of chronic diseases - Technavio

NEW YORK, Oct. 23, 2024 /PRNewswire/ -- Report on how AI is driving market transformation - The Global Human Platelet Lysate Market size is estimated to grow by USD 0.011 million from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 3.64% during the forecast period. Rising prevalence of chronic diseases is driving market growth, with a trend towards growing investments in stem cell research. However, stringent regulations and quality control requirements for human-derived products poses a challenge - Key market players include Amerigo Scientific, AventaCell BioMedical Corp. Ltd., BioLife Solutions Inc., Compass Biomedical Inc., Creative Biolabs, GeminiBio, Macopharma SA, Merck KGaA, Mill Creek Life Sciences Inc., MP Biomedicals Inc., PAN-Biotech GmbH, PL BioScience GmbH, Regenexx Des Moines, Sartorius AG, Sartorius CellGenix GmbH, Serana Europe GmbH, STEMCELL Technologies Inc., TCS Biosciences Ltd., TRINOVA BIOCHEM GmbH, and ZenBio Inc.. Continue Reading Technavio has announced its latest market research report titled Global human platelet lysate market 2024-2028 Key insights into market evolution with AI-powered analysis. Explore trends, segmentation, and growth drivers- View the snapshot of this report Market Driver The human platelet lysate market is experiencing significant growth due to increasing investments in stem cell research. Stem cells, with their potential to treat various diseases, necessitate high-quality cell culture supplements for growth and differentiation. Human platelet lysate, abundant in growth factors and cytokines, is a preferred choice in this field due to its compatibility with human cells and efficient cell proliferation properties. For instance, the California Institute for Regenerative Medicine (CIRM) recently approved an USD89 million investment for stem cell and gene therapy research, with nearly USD39 million allocated to four projects in CIRM's Clinical program. As stem cell and gene therapy advance, the demand for human platelet lysate will increase, driven by its crucial role in cell culture and regenerative medicine. Consequently, the global human platelet lysate market is expected to witness substantial growth during the forecast period, fueled by continued investments from governments, academic institutions, and biopharmaceutical companies in stem cell research. The Human Platelet Lysate market is experiencing significant growth due to increasing trends in personalized treatment solutions. This innovative biomedical product derived from human blood platelets is gaining popularity in various industries, including orthopedics and dermatology. Animal-derived supplements are being replaced with high-quality human platelet lysate for osteoarthritis treatment and cartilage regeneration. Key players in this market include cutting-edge innovators, providing active ingredients for therapeutic applications. Manufacturing obstacles and safety regulations are being addressed with efficient cell culture techniques and safety measures. Ethical considerations and contagious diseases are also prioritized, ensuring the highest standards. Applications extend to hair regrowth treatments in clinics and cytokines for neurodegenerative disorders like Parkinson's Disease and stem cell research. With a tailored strategy, regulatory landscape, and focus on safety and efficiency, the human platelet lysate market is poised for continued growth in the realm of regenerative medicine and tissue engineering. Request Sample of our comprehensive report now to stay ahead in the AI-driven market evolution! Market Challenges The human platelet lysate market faces substantial regulatory challenges, impacting product development and commercialization. Regulatory bodies like the FDA in the US and EMA in Europe impose rigorous requirements on human-derived product collection, processing, and testing to ensure safety and efficacy. These stringent regulations add to the cost and complexity of bringing products to market. Moreover, varying requirements in different countries can complicate global market entry. Companies must also maintain consistent product quality and adhere to safety protocols, such as those outlined in the ICH guidelines. Keeping up with evolving regulations and guidelines is essential. Overall, these regulatory hurdles pose a significant challenge to the growth of the global human platelet lysate market. The Human Platelet Lysate (HPL) market is witnessing significant growth due to its increasing applications in various clinical fields. One of the major challenges in this market is the shift towards Heparin-Free HPL, which is gaining popularity due to its compatibility with stem cell therapy and clinical trials. Heparin, a common anticoagulant used in traditional HPL, can negatively impact cell performance and reproducible results. Moreover, the market is witnessing an increasing focus on innovative treatments for chronic diseases such as cancer therapy and wound healing. Biotechnology companies are investing in the development of standardized, safe, and effective HPL for clinical applications. Pharmaceutical and healthcare facilities are exploring patent license agreements to manufacture and distribute HPL for various disease indications. Biogelx, a leading stem cell platform, is at the forefront of this trend, offering HPL for cell culture systems and tissue repair. HPL is rich in platelet-derived growth factors, which play a crucial role in cellular proliferation, angiogenesis, fibroblast proliferation, and extracellular matrix production. The market is also witnessing an increasing focus on the use of HPL in infectious diseases, drug discovery, and cell-based therapeutics. In conclusion, the Human Platelet Lysate market is a dynamic and growing industry, driven by the need for safe, effective, and reproducible results in various clinical applications, including stem cell therapy, clinical trials, chronic diseases, and tissue repair. Companies that can offer standardized and safe HPL are well-positioned to capitalize on this trend. Discover how AI is revolutionizing market trends- Get your access now! Segment Overview This human platelet lysate market report extensively covers market segmentation by Type 1.1 Heparin free human platelet lysate 1.2 Human platelet lysate with heparin Application 2.1 Research use 2.2 Clinical use Geography 3.1 North America 3.2 Europe 3.3 Asia 3.4 Rest of World (ROW) 1.1 Heparin free human platelet lysate- The Human Platelet Lysate market is experiencing significant growth due to its increasing usage in various research applications, particularly in biotechnology and pharmaceuticals. This market is driven by the rising demand for advanced diagnostic tools and therapeutic treatments. Key players in this market include Thermo Fisher Scientific, Sigma-Aldrich, and Gibco. These companies provide high-quality human platelet lysate products to meet the growing demand from researchers and healthcare professionals. Download a Sample of our comprehensive report today to discover how AI-driven innovations are reshaping competitive dynamics Research Analysis The Human Platelet Lysate (HPL) market is a significant segment of the biomedical industry, playing a crucial role in regenerative medicine, cell culture techniques, and therapeutic applications. HPL is derived from human platelets and contains various cytokines, growth factors, and other bioactive molecules that promote cellular proliferation, differentiation, and healing. HPL is used extensively in stem cell research, tissue engineering, and cell therapy for chronic diseases such as Parkinson's disease, neurodegenerative disorders, and injuries. Safety and efficiency are paramount in the production of HPL, with ethical considerations also being a significant factor. Fetal bovine serum (FBS) has traditionally been used as a supplement in cell culture, but HPL offers several advantages, including standardized, safe, and reproducible results. HPL is also heparin-free, making it an attractive alternative for pharmaceutical and healthcare facilities. The regulatory landscape for HPL is evolving, with clinical trials underway for various applications, including cancer therapy, wound healing, and infectious diseases. Innovative treatments using HPL are being explored in biotechnology, and the market is expected to grow significantly in the coming years due to its clinical applications in chronic diseases and therapeutic uses. Biogelx, for instance, is a leading provider of HPL for research and therapeutic applications, offering high-quality and consistent products for cell performance and differential potential. Market Research Overview The Human Platelet Lysate (HPL) market is a significant segment in the biomedical industry, playing a crucial role in regenerative medicine, cell culture techniques, and therapeutic applications. HPL is derived from platelets, which contain various bioactive compounds such as cytokines, platelet-derived growth factors, and other growth factors that promote cellular proliferation, angiogenesis, fibroblast proliferation, and extracellular matrix production. HPL is used in various clinical applications, including stem cell therapy for neurodegenerative disorders like Parkinson's disease, chronic diseases, and innovative treatments for infectious diseases. The regulatory landscape for HPL is stringent due to safety considerations, and manufacturers must adhere to ethical guidelines and quality standards. HPL is used in biotechnology and pharmaceutical industries for drug discovery and cell-based therapeutics, as well as in healthcare facilities for wound healing, cancer therapy, and tissue repair. The market for HPL is growing due to the increasing demand for high-quality solutions for personalized treatment and the development of heparin-free HPL and innovative cell culture systems. However, manufacturing obstacles and safety regulations pose challenges to the market's growth. Overall, the HPL market is a cutting-edge and active area of research, with potential applications in various industries and clinical indications. Table of Contents: 1 Executive Summary 2 Market Landscape 3 Market Sizing 4 Historic Market Size 5 Five Forces Analysis 6 Market Segmentation Type Heparin Free Human Platelet Lysate Human Platelet Lysate With Heparin Application Research Use Clinical Use Geography North America Europe Asia Rest Of World (ROW) 7 Customer Landscape 8 Geographic Landscape 9 Drivers, Challenges, and Trends 10 Company Landscape 11 Company Analysis 12 Appendix About Technavio Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavio's report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio's comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios. Contacts Technavio Research Jesse Maida Media & Marketing Executive US: +1 844 364 1100 UK: +44 203 893 3200 Email: [email protected] Website: SOURCE Technavio WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

细胞疗法

2022-10-21

·PRNewswire

$3.9 Billion Worldwide Serum-Free Media Industry to 2032 - Launch of Innovative Products in Serum-Free Media Ecosystems is Driving Growth

DUBLIN, Oct. 21, 2022 /PRNewswire/ -- The "Global Serum-Free Media Market: Focus on Media Type, End User, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering. The global market for serum-free media was valued at $1,022.4 million in 2021 and is expected to reach $3,920.5 million by 2032, registering a CAGR of 12.73% during the forecast period 2022-2032. The growth in the global serum-free media market is expected to be driven by factors such as the low risk of contamination in the media, rising awareness of media-based diagnostic testing, and significant number of funding for executing research and development. Market Lifecycle Stage The global serum-free media market is progressing rapidly with a significant increase in research and development activities pertaining to a wide range of animal component-free products for disease detection, accentuating their criticality in healthcare. Serum-free media has a critical role in the cellular diagnostics approach, as it ensures the safe and effective application for improved cell culture and cell therapy-based methods. Increasing investments in R&D for cell-based diagnostics is one of the major opportunities in the serum-free media market. Several clinical organizations and biopharmaceutical companies are working collaboratively on molecular biology applications, cell biology, cancer research, metagenomics, and plant research using serum-free media as a therapeutic means for applications in several disease indications in order to enable efficient diagnosis, treatment selection, dosage selection, and treatment monitoring. Impact Several techniques are employed in the development of serum-free media utilization for the process of removing cells, tissues, or organs from an animal or plant and putting them into a setting that will help them survive and/or proliferate. The selection of an adequate growth medium for in vitro cultivation is the most significant and important phase in cell culture. A growth medium, also known as a culture media, is a solution, gel, or powder that promotes the development of cells, small plants, or microorganisms. This serum-free medium market space has been segmented into different media types that include common serum-free, xeno-free, chemically-defined, animal component-free, and protein-free. Some of these media types are described in brief as follows: Common serum-free media: In common serum-free media, the composition is precisely defined, ensuring lot-to-lot consistency and eliminating the need to screen new lots of serum. In addition to facilitating the growth of numerous cell types for study, serum-free media also provide the advantage of removing the threat of infectious pathogens. The common serum-free media does not include human or animal serum or plasma in its direct or basic constituents. Chemically-defined media: Chemically-defined media is beneficial for a range of physiological research as well as for examining the minimal needs of microorganisms. Chemically-defined media are known to increase productivity and reduce costs in cell culture applications. A specified medium will enhance reproducibility and enable a more precise prediction of the final yield from a certain procedure. Animal component-free media: Animal-free media, also known as animal component-free and animal origin-free cell culture media, can offer the essential components required for cell growth and performance similar to the media, including serum, but without the drawbacks associated with using the serum. Animal component-free media not only mitigates the risk of prions and other viral contaminants but also improves regulatory approvals and speed-to-market. Protein-free media: The protein-free media are ideal for producing proteins as they promote healthy cell development and excellent protein yield. The proteins in the protein-free medium can be substituted with low-molecular-weight components such as peptides, hormones, and inorganic ions. However, protein-free designated commercially available media frequently contain just trace amounts of recombinant proteins. Impact of COVID-19 The current global serum-free media market comprises different media types. The unexpected crisis of the pandemic has surged the demand for essentials and thus, increased the demand for serum-free media. There was increased demand for serum-free media from biopharmaceutical companies. Overall, the impact of COVID-19 on the global serum-free media market size has been low-moderate. Some of the market players have reported a slight decline in sales. However, it is worth mentioning that with the ease of restrictions after Q2 2021, the market for serum-free media gained significant momentum and is anticipated to grow during the forecast period 2022-2032. As a result of the pandemic and reduced output at manufacturing facilities, the pandemic caused a short-term drop in manufacturing and sales of serum-free media. The global serum-free media market will eventually return to its usual growth trajectory over time. With many people impacted by COVID-19 all around the world, pharmaceutical companies are ramping up manufacturing to create vaccinations. Such trends are generating revenue potential for serum-free media market participants. Lonza Group AG, a Swiss multinational chemicals and biotechnology firm, is earning notoriety for its non-animal ProVeroTM1 Serum-free Medium, which aids in vaccine manufacture. Recent Developments in the Global Serum-Free Media Market In August 2022, Thermo Fisher Scientific Inc. expanded the cell culture media manufacturing facility in Grand Island, New York, to support the production of new vaccines and biologics. This expansion would support the worldwide media supply and increase the capacity to create high-quality technologies. In May 2022, FUJIFILM Irvine Scientific completed its new bioprocessing innovation and collaboration center in China. The new center would enable local resources and expertise required to optimize cell culture media and workflows to aid the production of vaccines, advanced therapies, and biotherapeutic drug development in China. In September 2021, Bio-Techne Corporation developed a new medium ExCellerate IpsC expansion medium, for IpsC research in regenerative medicine. In April 2021, PromoCell GmbH launched an upgrade to its Keratinocyte Cell Culture Portfolio. The company expanded its improved animal-extract-free Keratinocyte Growth Medium 3 for the standardized isolation and development of juvenile and adult Normal Human Keratinocytes. In March 2021, the company also launched its improved third-generation Melanocyte Cell Culture Portfolio. Melanocyte Growth Medium M3 is a serum-free, bovine pituitary extract (BPE)-free, and phorbol myristate acetate (PMA)-free media formulation. Demand - Drivers and Limitations Following are the demand drivers for the global serum-free media market: Low Risk of Contamination as a Demand Driver Launch of innovative products in Serum-Free Media Ecosystem Low reception cost involving small and medium enterprises in comparison to animal derived media The market is expected to face some limitations too due to the following challenges: Slow Growth Rate in Comparison to Serum-Supplemented Media Requirement of Diverse Cell-Type for Specific Media Formulation Key Market Players and Competition Synopsis The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration. Some of the prominent names established in this market are: Company Type 1: Serum-Free Media Private Industry MP BIOMEDICALS. HiMedia Laboratories R&D Systems, Inc. Sino Biological, Inc. PAN-Biotech. PromoCell GmbH Athena Environmental Sciences, Inc. STEMCELL Technologies Inc. Company Type 2: Serum-Free Media Public Industry Corning Incorporated Lonza Group AG Merck KgaA Sartorius AG Thermo Fisher Scientific Inc. FUJIFILM Holdings Corporation Danaher. Key Topics Covered: 1 Market Overview 2 Global Serum-Free Media: Market Dynamics 2.1 Overview 2.2 Impact Analysis 2.2.1 Drivers 2.2.1.1 Low Risk of Contamination as a Demand Driver 2.2.1.2 Launch of innovative products in Serum-Free Media Ecosystem 2.2.1.3 Low reception cost involving small and medium enterprises in comparison to animal derived media 2.2.2 Restraints 2.2.2.1 Slow Growth Rate in Comparison to Serum-Supplemented Media 2.2.2.2 Requirement of Diverse Cell-Type for Specific Media Formulation 2.2.3 Opportunities 2.2.3.1 Regulatory Bodies Across the Globe Encourage the Use of Animal-Free Media in Biological Products 2.2.3.2 Extensive Adoption of Serum-Free Media in Biopharmaceutical Companies 3 Global Serum-Free Media (by Media Type), $Mn, 2021-2032 3.1 Overview 3.2 Common Serum-Free 3.3 Xeno-Free 3.4 Chemically-Defined 3.5 Animal Component-Free 3.6 Protein-Free 4 Global Serum-Free Media (by End User), $Million, 2021-2032 4.1 Overview 4.2 Biopharmaceutical Companies 4.2.1 Biopharmaceutical Companies, by Media Type 4.3 Academic and Research Organizations 4.3.1 Academic and Research Organizations, by Media Type 4.4 Clinical Research Organizations 4.4.1 Clinical Research Organizations, by Media Type 4.5 Others 4.5.1 Others, by Media Type 5 Global Serum-Free Media Market (by Region), $Million, 2021-2032 6 Competitive Landscape 6.1 Overview 6.2 Key Developments and Strategies 6.2.1 Business Expansions 6.2.2 Product Launches and Developments 6.2.3 Mergers and Acquisitions 6.2.4 Others 6.3 Market Share Analysis (by Company) 6.4 Growth-Share Analysis (by Company) 7 Company Profiles For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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100 项与 PAN-Biotech GmbH 相关的药物交易

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100 项与 PAN-Biotech GmbH 相关的转化医学

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