{"id":684,"date":"2024-02-08T16:05:58","date_gmt":"2024-02-08T15:05:58","guid":{"rendered":"https:\/\/asa-enzyme.de\/?post_type=product&#038;p=684"},"modified":"2026-09-15T16:57:29","modified_gmt":"2026-09-15T14:57:29","slug":"small-batch-fill-finish-tailored-for-phase-i-ii-clinical-trials","status":"publish","type":"product","link":"https:\/\/asa-enzyme.de\/de\/produkt\/small-batch-fill-finish-tailored-for-phase-i-ii-clinical-trials\/","title":{"rendered":"Small-Batch Fill &#038; Finish: Tailored for Phase I &#038; II Clinical Trials"},"content":{"rendered":"<h2 class=\"otQkpb\" role=\"heading\" aria-level=\"3\" data-wiz-attrbind=\"aria-level=uylxPc_t\/fLk2Md\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 20px; font-weight: 600; margin: 24px 0px 12px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Small-Batch Fill &amp; Finish: Tailored for Phase I &amp; II Clinical Trials and toxicological studies<!--TgQPHd|||[]--><\/h2>\n<div class=\"n6owBd awi2gc\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIChAA\" data-complete=\"true\" data-processed=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 12px 0px 16px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Small-batch fill and finish services tailored specifically for <strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Phase I and Phase II clinical trials <!--TgQPHd|||[]--><\/strong>is our specialty. We support clinical development by providing high-precision processes in Accordance with current GMP PH. EUR Annex 1 regulations.<!--TgQPHd|||[]--><\/div>\n<div data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIChAA\" data-complete=\"true\" data-processed=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 12px 0px 16px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><\/div>\n<div class=\"n6owBd awi2gc\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEICxAA\" data-complete=\"true\" data-processed=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 12px 0px 16px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Our specialized capabilities include:<!--TgQPHd|||[]--><\/div>\n<ul class=\"KsbFXc U6u95\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-ved=\"2ahUKEwih4eX33_CWAxV4c_EDHfuWKSkQ-7AUegYIAQgMEAA\" data-hveid=\"CAEIDBAA\" data-complete=\"true\" data-processed=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 12px 0px 16px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">\n<li class=\"Z1qcYe\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIDBAB\" data-complete=\"true\" data-sae=\"\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px 0px 12px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><span class=\"iNqyIf\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Micro-Volume Filling:<!--TgQPHd|||[]--><\/strong> Expert handling and precision filling of small quantities ranging from <strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">0.3 mL to 1 mL in glass vials<!--TgQPHd|||[]--><\/strong>.<!--TgQPHd|||[]--><\/span><!--TgQPHd|||[]--><\/li>\n<li class=\"Z1qcYe\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIDBAC\" data-complete=\"true\" data-sae=\"\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px 0px 12px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><span class=\"iNqyIf\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Validated Processes:<!--TgQPHd|||[]--><\/strong> Full process reliability backed by a robust <strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Aseptic Process Simulation (APS)<!--TgQPHd|||[]--><\/strong> that covers your specific volume and configuration needs.<!--TgQPHd|||[]--><\/span><!--TgQPHd|||[]--><\/li>\n<li class=\"Z1qcYe\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIDBAD\" data-complete=\"true\" data-sae=\"\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px 0px 12px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><span class=\"iNqyIf\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Flexible Clinical Capacity:<!--TgQPHd|||[]--><\/strong> Scaled efficiently to fill and finish <strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">up to 2,000 vials per week<!--TgQPHd|||[]--><\/strong>, minimizing product waste while meeting tight clinical timelines.<!--TgQPHd|||[]--><\/span><!--TgQPHd|||[]--><\/li>\n<li class=\"Z1qcYe\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIDBAE\" data-complete=\"true\" data-sae=\"\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px 0px 12px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><span class=\"iNqyIf\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\"><strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">The Annex 1 Advantage:<!--TgQPHd|||[]--><\/strong> Every batch is processed within our state-of-the-art cleanrooms, providing the <strong class=\"rQesXe MPyX\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-complete=\"true\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 700; margin: 0px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">full protection of Ph. Eur. Annex 1 compliance<!--TgQPHd|||[]--><\/strong> from day one.<!--TgQPHd|||[]--><\/span><!--TgQPHd|||[]--><\/li>\n<p><!--TgQPHd|||[]--><\/ul>\n<div class=\"n6owBd awi2gc\" data-sfc-cp=\"\" data-sfc-root=\"ep\" data-hveid=\"CAEIDRAA\" data-complete=\"true\" data-processed=\"true\" aria-owns=\"action-menu-parent-container\" data-copy-service-computed-style=\"font-family: &quot;Google Sans&quot;, Arial, sans-serif, &quot;Noto Color Emoji&quot;; font-size: 16px; font-weight: 400; margin: 12px 0px 16px; text-decoration: none; border-bottom: 0px rgb(10, 10, 10);\">Partner with us to transition your molecule from the lab to clinical trials with uncompromising safety, regulatory alignment, and agility.<\/div>\n<p>We already succesfully provided the adjuvant for the ongoing clinical trial I of <a href=\"https:\/\/ekfs.de\/en\/scientific-funding\/currently-funded-projects\/panhpvax-extension-phase-i-clinical-trial-prophylactic\" target=\"_blank\" rel=\"noopener\">PANHPVAX<\/a> (<span style=\"font-size: small;\">EudraCT Number: 2021-002584-22) <\/span>in cooperation with the HZI from Brunswick. In addition to that we participated in <a href=\"https:\/\/www.thervacb.eu\/\" target=\"_blank\" rel=\"noopener\">TherVac B<\/a>.<\/p>\n<p><strong>Produktdatenblatt: <\/strong><a href=\"https:\/\/asa-enzyme.de\/wp-content\/uploads\/2024\/02\/Pharmaceuticals-GMP.pdf\">Pharmazeutische Produkte\/ GMP<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Good Manufacturing Practice<\/p>\n<p>Auftragsbef\u00fcllung f\u00fcr klinische Studien unter Reinraumbedingungen<\/p>","protected":false},"featured_media":685,"template":"","meta":[],"product_cat":[30],"product_tag":[],"class_list":["post-684","product","type-product","status-publish","has-post-thumbnail","product_cat-pharmaceuticals","first","instock","taxable","shipping-taxable","product-type-simple"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.8 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Small-Batch Fill &amp; Finish: Tailored for Phase I &amp; II Clinical Trials - ASA Spezialenzyme GmbH<\/title>\n<meta name=\"description\" content=\"Tailored for Phase I &amp; II Clinical Trials. 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