{"id":10585,"date":"2026-11-04T18:52:43","date_gmt":"2026-11-04T17:52:43","guid":{"rendered":"https:\/\/seamlessbio.de\/?page_id=10585"},"modified":"2026-11-04T18:52:43","modified_gmt":"2026-11-04T17:52:43","slug":"edta-humanplasma-pk-bioanalytik","status":"publish","type":"page","link":"https:\/\/seamlessbio.de\/de\/human-edta-plasma-pk-bioanalysis\/","title":{"rendered":"EDTA-Humanplasma f\u00fcr PK &amp; Bioanalytik"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10585\" class=\"elementor elementor-10585\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8e71747 e-con e-atomic-element e-flexbox-base e-default-div e-6c5e5f5 \" data-id=\"8e71747\" data-element_type=\"e-flexbox\" data-e-type=\"e-flexbox\" data-interaction-id=\"8e71747\" data-e-type=\"e-flexbox\" data-id=\"8e71747\">\n    \t\t<div class=\"elementor-element elementor-element- elementor-widget elementor-widget-html\" data-id=\"\" 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p{font-size:13px;line-height:1.6;color:#555;margin:0}\n.sbp-table{width:100%;border-collapse:collapse;font-size:14px}\n.sbp-table th{background:#18b7b2;color:#fff;padding:11px 16px;text-align:left;font-weight:700}\n.sbp-table td{padding:11px 16px;border-bottom:1px solid #eee;vertical-align:top}\n.sbp-table tr:nth-child(even) td{background:#f7fbfb}\n.sbp-table td:first-child{font-weight:700;color:#202020}\n.sbp-ul{list-style:none;padding:0;margin:0}\n.sbp-ul li{font-size:14px;line-height:1.6;color:#555;padding:8px 0 8px 20px;border-bottom:1px solid #eef7f6;position:relative}\n.sbp-ul li::before{content:\"\u2014\";position:absolute;left:0;color:#18b7b2;font-weight:700}\n.sbp-ul li strong{color:#202020}\n.sbp-cta{background:linear-gradient(135deg,#0d9490 0%,#18b7b2 60%,#1ec8c2 100%);border-radius:24px;padding:52px;text-align:center;color:#fff;margin-top:56px}\n.sbp-cta h2{font-size:26px;font-weight:900;margin:0 0 12px;color:#fff;border:none;display:block}\n.sbp-cta p{font-size:16px;color:rgba(255,255,255,.9);margin:0 0 28px}\n.sbp-cta-btns{display:flex;justify-content:center;gap:14px;flex-wrap:wrap}\n.sbp-cta .sbp-btn{background:#fff;color:#18b7b2!important}\n.sbp-cta .sbp-btn-o{border-color:rgba(255,255,255,.6);color:#fff!important;background:transparent}\n.sbp-faq{padding:18px 0;border-bottom:1px solid rgba(24,183,178,.15)}\n.sbp-faq h3{font-size:16px;font-weight:700;color:#202020;margin:0 0 8px}\n.sbp-faq p{font-size:14px;line-height:1.7;color:#555;margin:0}\n.sbp-step{display:flex;gap:18px;padding:20px;background:#fff;border:1.5px solid rgba(24,183,178,.18);border-radius:14px;margin-bottom:12px}\n.sbp-step-num{flex-shrink:0;width:36px;height:36px;background:#18b7b2;color:#fff;border-radius:50%;display:flex;align-items:center;justify-content:center;font-size:15px;font-weight:800}\n.sbp-step div h3{font-size:15px;font-weight:700;color:#202020;margin:0 0 6px}\n.sbp-step div p{font-size:13px;line-height:1.6;color:#555;margin:0}\n@media(max-width:1024px){.sbp-grid-3{grid-template-columns:1fr 1fr}.sbp-grid-4{grid-template-columns:1fr 1fr}}\n@media(max-width:768px){.sbp-wrap{padding:0 20px}.sbp-hero{padding:32px 20px}.sbp-grid-3,.sbp-grid-2,.sbp-grid-4{grid-template-columns:1fr}.sbp-alt{padding:24px 18px}}\n<\/style>\n<div class=\"sbp-page\"><div class=\"sbp-wrap\">\n<div class=\"sbp-bc\"><a href=\"\/\">Home<\/a><span>\/<\/span><a href=\"\/human-sera-plasma-and-more\/\">Human Sera &amp; Plasma<\/a><span>\/<\/span>EDTA Plasma for PK &amp; Bioanalysis<\/div>\n\n<div class=\"sbp-hero\">\n<span class=\"sbp-eyebrow\">Bioanalysis \u00b7 PK Studies \u00b7 LC-MS\/MS \u00b7 Ligand-Binding Assays<\/span>\n<h1>Human EDTA Plasma for PK Studies &amp; Bioanalytical Method Validation<\/h1>\n<p>Blank human plasma in the anticoagulant your study samples use \u2014 K2EDTA, K3EDTA or sodium EDTA. Sterile filtered, from EU donors, as pooled plasma or as individual donor lots for selectivity and matrix-effect testing. From 10 mL to bulk, with a CoA for every lot.<\/p>\n<div class=\"sbp-tags\"><span>K2EDTA \u00b7 K3EDTA \u00b7 Sodium EDTA<\/span><span>Individual Donor Lots<\/span><span>Hemolyzed &amp; Lipemic on Request<\/span><span>Sterile Filtered 0.2 \u00b5m<\/span><span>EU Donors<\/span><\/div>\n<div class=\"sbp-btns\"><a href=\"\/request-quote\/\" class=\"sbp-btn\">Request a Quote<\/a><a href=\"\/contact\/\" class=\"sbp-btn-o\">Request a Test Sample<\/a><\/div>\n<\/div>\n\n<div class=\"sbp-section sbp-grid-2\">\n<div><h2 class=\"sbp-h2\">Blank Matrix That Matches Your Study Samples<\/h2>\n<p class=\"sbp-intro\">Calibration standards and QC samples in a PK study should be prepared in the same matrix as the study samples \u2014 the same species and the same anticoagulant. A mismatch adds an avoidable variable to your method validation.<\/p>\n<p class=\"sbp-intro\">We supply human EDTA plasma in all common EDTA formats and volumes, so the blank matrix for calibrators, QCs and selectivity testing comes from one documented source for the whole study.<\/p><\/div>\n<div class=\"sbp-card\"><h3>What Bioanalytical Labs Need<\/h3><ul class=\"sbp-ul\">\n<li><strong>Matching anticoagulant<\/strong> \u2014 K2EDTA, K3EDTA or sodium EDTA, plus heparin and citrate.<\/li>\n<li><strong>Individual donor lots<\/strong> \u2014 ICH M10 asks for selectivity testing in blank matrix from at least 6 individual sources for chromatographic methods and at least 10 for ligand-binding assays.<\/li>\n<li><strong>Hemolyzed and lipemic plasma<\/strong> \u2014 to evaluate the effect of hemolysis and lipemia on your method.<\/li>\n<li><strong>Enough pooled matrix<\/strong> \u2014 for calibrators and QCs across the full study, from one lot.<\/li>\n<li><strong>Documentation<\/strong> \u2014 CoA per lot and donor screening report.<\/li>\n<\/ul><\/div>\n<\/div>\n\n<div class=\"sbp-alt\">\n<h2 class=\"sbp-h2\">Plasma Formats for PK and Bioanalysis<\/h2>\n<p class=\"sbp-intro\">Standard catalogue items and custom collections from defined donors.<\/p>\n<div class=\"sbp-grid-3\">\n<div class=\"sbp-card\"><h3>Pooled Blank Plasma<\/h3><p>Sterile filtered human EDTA plasma pooled from healthy EU donors. 10 mL and 250 mL, bulk volumes on request.<\/p><\/div>\n<div class=\"sbp-card\"><h3>Individual Donor Sets<\/h3><p>Single-donor plasma lots for selectivity and matrix-effect testing \u2014 for example sets of 6 or 10 individual donors, in your anticoagulant.<\/p><\/div>\n<div class=\"sbp-card\"><h3>Hemolyzed &amp; Lipemic Plasma<\/h3><p>Plasma with hemolysis or lipemia for the corresponding validation experiments. Available on request.<\/p><\/div>\n<div class=\"sbp-card\"><h3>Sodium EDTA Plasma<\/h3><p>Human plasma collected in sodium EDTA for methods and studies that specify this counter-ion. Available on request.<\/p><\/div>\n<div class=\"sbp-card\"><h3>Other Anticoagulants<\/h3><p>Lithium heparin, citrate 3.2 % and 3.8 % and ACD-A are listed under <a href=\"\/human-plasma-pooled\/\">pooled human plasma<\/a>.<\/p><\/div>\n<div class=\"sbp-card\"><h3>Lot Reservation<\/h3><p>Reserve one qualified lot for the whole study, so calibrators and QCs never change matrix mid-programme.<\/p><\/div>\n<\/div>\n<\/div>\n\n<div class=\"sbp-section sbp-grid-2\">\n<div><h2 class=\"sbp-h2\">Specifications<\/h2>\n<table class=\"sbp-table\"><tr><th>Parameter<\/th><th>Specification<\/th><\/tr>\n<tr><td>Matrix<\/td><td>Human EDTA plasma (K2EDTA, K3EDTA, sodium EDTA on request)<\/td><\/tr>\n<tr><td>Origin<\/td><td>Self-reported healthy EU donors<\/td><\/tr>\n<tr><td>Processing<\/td><td>Sterile filtered (0.2 \u00b5m)<\/td><\/tr>\n<tr><td>Donor format<\/td><td>Pooled or single donor<\/td><\/tr>\n<tr><td>Infection markers<\/td><td>HIV-1\/2 Ab, HBsAg and HCV Ab non-reactive (CE-marked tests)<\/td><\/tr>\n<tr><td>Microbial count<\/td><td>TAMC + TYMC below 10 CFU\/mL<\/td><\/tr>\n<tr><td>Volumes<\/td><td>10 mL \u00b7 250 mL \u00b7 bulk on request<\/td><\/tr>\n<tr><td>Storage<\/td><td>At or below \u221218 \u00b0C, shipped on dry ice<\/td><\/tr>\n<tr><td>Shelf life<\/td><td>4 years from manufacture<\/td><\/tr>\n<\/table><\/div>\n<div class=\"sbp-card\"><h3>Quality &amp; Documentation<\/h3><ul class=\"sbp-ul\">\n<li><strong>Certificate of Analysis<\/strong> \u2014 for every lot.<\/li>\n<li><strong>Donor screening report<\/strong> \u2014 each donation tested individually.<\/li>\n<li><strong>Ethical sourcing<\/strong> \u2014 donations collected in line with the EDQM Guide to the Preparation, Use and Quality Assurance of Blood Components.<\/li>\n<li><strong>Certified manufacturing<\/strong> \u2014 our manufacturing partner works under ISO 9001 and ISO 13485.<\/li>\n<li><strong>Research use<\/strong> \u2014 for in vitro use only, not for administration to humans.<\/li>\n<\/ul><\/div>\n<\/div>\n\n<div class=\"sbp-section\">\n<h2 class=\"sbp-h2\">How We Work Together<\/h2>\n<div class=\"sbp-step\"><div class=\"sbp-step-num\">01<\/div><div><h3>Tell Us Your Method<\/h3><p>Anticoagulant, number of individual donors, volumes and any special matrices such as hemolyzed or lipemic plasma.<\/p><\/div><\/div>\n<div class=\"sbp-step\"><div class=\"sbp-step-num\">02<\/div><div><h3>Test Sample &amp; Documents<\/h3><p>We send a test sample with CoA and donor screening report for your method development.<\/p><\/div><\/div>\n<div class=\"sbp-step\"><div class=\"sbp-step-num\">03<\/div><div><h3>Reserve Your Lot<\/h3><p>Once the matrix works in your method, we reserve the lot for the duration of your study.<\/p><\/div><\/div>\n<div class=\"sbp-step\"><div class=\"sbp-step-num\">04<\/div><div><h3>Delivery on Dry Ice<\/h3><p>Frozen delivery across Germany and the EU, with documentation for every shipment.<\/p><\/div><\/div>\n<\/div>\n\n<div class=\"sbp-section\">\n<h2 class=\"sbp-h2\">Frequently Asked Questions<\/h2>\n<div class=\"sbp-faq\"><h3>Which anticoagulant should I use for blank plasma in a PK study?<\/h3><p>Use the anticoagulant of your study samples. Most clinical PK studies collect K2EDTA plasma, but some protocols specify K3EDTA or sodium EDTA. We supply all three, plus heparin and citrate plasma.<\/p><\/div>\n<div class=\"sbp-faq\"><h3>How many individual donors do I need for method validation?<\/h3><p>ICH M10 asks for selectivity testing in blank matrix from at least 6 individual sources for chromatographic methods and at least 10 for ligand-binding assays. We supply individual donor sets in these sizes.<\/p><\/div>\n<div class=\"sbp-faq\"><h3>Do you supply hemolyzed and lipemic plasma?<\/h3><p>Yes, on request. Tell us the anticoagulant and volume you need for your hemolysis and lipemia experiments.<\/p><\/div>\n<div class=\"sbp-faq\"><h3>Is the plasma sterile?<\/h3><p>Our pooled EDTA plasma is sterile filtered through 0.2 \u00b5m, with a total microbial count below 10 CFU\/mL.<\/p><\/div>\n<div class=\"sbp-faq\"><h3>How is the plasma tested?<\/h3><p>Every donation is tested for HIV-1\/2 antibodies, hepatitis B surface antigen and hepatitis C antibodies with CE-marked tests and is non-reactive.<\/p><\/div>\n<div class=\"sbp-faq\"><h3>What volumes are available?<\/h3><p>10 mL and 250 mL as standard, bulk volumes and individual donor sets on request.<\/p><\/div>\n<\/div>\n\n<p class=\"sbp-intro\">More on plasma and serum for bioanalysis: <a href=\"\/human-serum-plasma-ivd-cro\/\">human serum and plasma for IVD and CRO applications<\/a>, <a href=\"\/human-plasma-single-donor\/\">single donor human plasma<\/a> and our overview of all <a href=\"\/biological-raw-materials\/\">biological raw materials<\/a>.<\/p>\n\n<div class=\"sbp-cta\"><h2>Get the Right Blank Matrix for Your Next Study<\/h2><p>Tell us your anticoagulant, donor numbers and volumes. You receive a quote with CoA and donor documentation \u2014 and a test sample on request.<\/p><div class=\"sbp-cta-btns\"><a href=\"\/request-quote\/\" class=\"sbp-btn\">Request a Quote<\/a><a href=\"\/contact\/\" class=\"sbp-btn-o\">Contact Us<\/a><\/div><\/div>\n<\/div><\/div>\n<script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"BreadcrumbList\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/seamlessbio.de\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Human Sera & Plasma\",\"item\":\"https:\/\/seamlessbio.de\/human-sera-plasma-and-more\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"EDTA Plasma for PK & Bioanalysis\",\"item\":\"https:\/\/seamlessbio.de\/human-edta-plasma-pk-bioanalysis\/\"}]},{\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Which anticoagulant should I use for blank plasma in a PK study?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Use the anticoagulant of your study samples. 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Sterile filtered, from EU donors, as pooled plasma or as individual [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","footnotes":""},"class_list":["post-10585","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Human EDTA Plasma for PK Studies &amp; Bioanalysis | SeamlessBio<\/title>\n<meta name=\"description\" content=\"Blank human K2EDTA, K3EDTA and sodium EDTA plasma for PK studies and method validation \u2014 individual donor lots, hemolyzed and lipemic plasma, EU donors.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/seamlessbio.de\/de\/edta-humanplasma-pk-bioanalytik\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Human EDTA Plasma for PK Studies &amp; Bioanalysis | SeamlessBio\" \/>\n<meta property=\"og:description\" content=\"Blank human K2EDTA, K3EDTA and sodium EDTA plasma for PK studies and method validation \u2014 individual donor lots, hemolyzed and lipemic plasma, EU donors.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/seamlessbio.de\/de\/edta-humanplasma-pk-bioanalytik\/\" \/>\n<meta property=\"og:site_name\" content=\"SeamlessBio\" \/>\n<meta property=\"og:image\" content=\"https:\/\/seamlessbio.de\/wp-content\/uploads\/2026\/04\/134428046.png\" \/>\n\t<meta property=\"og:image:width\" content=\"973\" \/>\n\t<meta property=\"og:image:height\" content=\"288\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-edta-plasma-pk-bioanalysis\\\/\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/human-edta-plasma-pk-bioanalysis\\\/\",\"name\":\"Human EDTA Plasma for PK Studies & Bioanalysis | SeamlessBio\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\"},\"datePublished\":\"2026-11-04T17:52:43+00:00\",\"description\":\"Blank human K2EDTA, K3EDTA and sodium EDTA plasma for PK studies and method validation \u2014 individual donor lots, hemolyzed and lipemic plasma, EU donors.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-edta-plasma-pk-bioanalysis\\\/#breadcrumb\"},\"inLanguage\":\"de\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/seamlessbio.de\\\/human-edta-plasma-pk-bioanalysis\\\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/human-edta-plasma-pk-bioanalysis\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Start\",\"item\":\"https:\\\/\\\/seamlessbio.de\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Human EDTA Plasma for PK &#038; Bioanalysis\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/seamlessbio.de\\\/#website\",\"url\":\"https:\\\/\\\/seamlessbio.de\\\/\",\"name\":\"SeamlessBio\",\"description\":\"Human serum, plasma and hPL, single-use bioprocessing bags, serum-free media, animal sera and FBS. 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