{"id":21594,"date":"2018-09-25T11:46:01","date_gmt":"2018-09-25T03:46:01","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/quality-management-system\/"},"modified":"2019-08-23T19:08:40","modified_gmt":"2019-08-23T11:08:40","slug":"quality-management-system","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/quality-management-system\/","title":{"rendered":"Environment, Methods, Materials and Validation"},"content":{"rendered":"

[et_pb_section bb_built=”1″ _builder_version=”3.27.2″ background_color=”#F2F2F2″ custom_padding=”0px||0px|” z_index_tablet=”500″ box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” _i=”0″ _address=”0″ next_background_color=”#ffffff” global_module=”22006″][et_pb_row global_parent=”22006″ column_structure=”1_3,1_3,1_3″ module_class=”icon_list” _builder_version=”3.25″ custom_padding=”||0px|” _i=”0″ _address=”0.0″][et_pb_column type=”1_3″ global_parent=”22006″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”0.0.0″][et_pb_blurb global_parent=”22006″ url=”\/en\/development\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon1_0919.png” module_class=”icon-quick icon-events” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.0.0″ link_option_url=”\/en\/development\/”]<\/p>\n

Oligonucleotide Manufacturing Process Development<\/h6>\n

[\/et_pb_blurb][et_pb_blurb global_parent=”22006″ url=”\/en\/analytics-and-chemistry-research\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png” module_class=”icon-quick icon-tools” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”1″ _address=”0.0.0.1″ link_option_url=”\/en\/analytics-and-chemistry-research\/”]<\/p>\n

Analytical Methods
& Stability Study<\/h6>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ global_parent=”22006″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”1″ _address=”0.0.1″][et_pb_blurb global_parent=”22006″ url=”\/en\/clinical-nucleic-acid-drug-manufacture\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon3_0919.png” module_class=”icon-quick icon-resource” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.1.0″ link_option_url=”\/en\/clinical-nucleic-acid-drug-manufacture\/”]<\/p>\n

Oligonucleotide
Manufacturing for Clinical Phases<\/h6>\n

[\/et_pb_blurb][et_pb_blurb global_parent=”22006″ url=”\/en\/commercial-oligonucleotides-api-manufacture\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon9_0919.png” module_class=”icon-quick icon-buy” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”1″ _address=”0.0.1.1″ link_option_url=”\/en\/commercial-oligonucleotides-api-manufacture\/”]<\/p>\n

Oligonucleotide
Manufacturing for Commercial Phases<\/h6>\n

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ global_parent=”22006″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”2″ _address=”0.0.2″][et_pb_blurb global_parent=”22006″ url=”\/en\/drug-product-fill-and-finish\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon2_0919.png” module_class=”icon-quick icon-orders” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.2.0″ link_option_url=”\/en\/drug-product-fill-and-finish\/”]<\/p>\n

Preparation, aseptic filling or
lyophilization<\/h6>\n

[\/et_pb_blurb][et_pb_blurb global_parent=”22006″ url=”\/en\/quality-management-system\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon8_0919.png” module_class=”icon-quick icon-user-center” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”0 |||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”1″ _address=”0.0.2.1″ link_option_url=”\/en\/quality-management-system\/”]<\/p>\n

Validation & Quality<\/h6>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ _builder_version=”3.22″ custom_padding=”54px|0px|11px|0px” _i=”1″ _address=”1″ prev_background_color=”#F2F2F2″ next_background_color=”#F4f4f4″][et_pb_row _builder_version=”3.25″ border_color_bottom=”#00AECC” border_style_bottom=”none” custom_margin=”-30px|||” custom_padding=”0||2px|0px” _i=”0″ _address=”1.0″][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”1.0.0″][et_pb_text _builder_version=”3.26.8″ text_text_color=”#242424″ text_font_size=”22px” custom_margin=”||10px|” custom_padding=”|||” _i=”0″ _address=”1.0.0.0″]<\/p>\n

\"\"Validation & Quality<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ custom_padding=”0px|0px|10px|0px” _i=”1″ _address=”1.1″][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”1.1.0″][et_pb_image src=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/chemistry-research-banner.jpg” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”3.23″ _i=”0″ _address=”1.1.0.0″ \/][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”3.25″ custom_padding=”0px|0px|0px|0px” _i=”2″ _address=”1.2″][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”1.2.0″][et_pb_text _builder_version=”3.26.8″ custom_margin=”||15px|” custom_margin_last_edited=”on|desktop” custom_padding=”||0px|” _i=”0″ _address=”1.2.0.0″]<\/p>\n

Environment, Methods, Materials and Validation<\/strong><\/h3>\n

RiboBio’s cGMP manufacturing facility meets or exceeds current IS08, IS07 and IS05 requirements as well as ICH Q7(cGMP) and CFDA Title 21 part 210(cGMP) requirements. To ensure RiboBio continues to meet or exceed these requirements, RiboBio conducts continuous and systematic on-going testing of facilities, water and air supplies, major equipment and in-coming raw materials.<\/p>\n

\u2022 Validated procedures for the strict qualification of raw materials from reliable, industry-leading suppliers
\u2022 Centralized gas supply with on-site purification systems for air and water
\u2022 Operating procedures for equipment cleaning, sanitization and validation.<\/p>\n

[\/et_pb_text][et_pb_toggle title=”\u25cf Establishment and formulation of product quality standards” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”1″ _address=”1.2.0.1″]<\/p>\n

Establish and develop new drug quality standards from the safety and efficacy of drugs, the safety of impurities, batches of process development and existing testing technologies.<\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”\u25cf Finished product sequence verification” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”2″ _address=”1.2.0.2″]<\/p>\n

Sequence verification is critical to the quality of nucleic acid drugs. We have a leading LC-MS platform and a powerful analysis software to ensure better detection resolution, sensitivity, dynamic range and experienced personnel to provide drug sequence verification services. The sequences are available for oligo-conjugated cholesterol, various linkers, modified or restricted bases, sugar modifications, and mixtures.<\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”\u25cf Solvent residue analysis and test” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”3″ _address=”1.2.0.3″]<\/p>\n

We test the organic solvent in the production of oligonucleotide products that not completely removed during the process, and verify the residual solvent method to ensure that the set limits and development methods are in line with product specifications and GMP requirements.<\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”\u25cf Element impurity analysis” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”4″ _address=”1.2.0.4″]<\/p>\n

According to the ICH Element Impurity Guide and the USP standard, we conduct suitable verification for corresponding requirement to detect the elemental impurity in oligonucleotide products.\u00a0<\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”\u25cf Anion and cation analysis and test” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”5″ _address=”1.2.0.5″]<\/p>\n

We provide detection services for potential inorganic anions, inorganic cations, and partially polar organics in oligonucleotide products.<\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”\u25cf Water Detection” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”6″ _address=”1.2.0.6″]<\/p>\n

We provide water testing service for oligonucleotide products.<\/p>\n

[\/et_pb_toggle][et_pb_toggle title=”\u25cf Analysis and detection of microorganisms and endotoxins” _builder_version=”3.26.8″ title_text_color=”#1e73be” title_font_size=”14px” title_line_height=”1.4em” body_font=”||||||||” background_color=”#ffffff” border_width_all=”0px” border_style_all=”none” custom_margin=”||4px|” custom_padding=”0px||0px|0px” custom_padding_phone=”|0px||0px” custom_padding_last_edited=”off|desktop” custom_css_toggle_title=”font-weight:bold;text-align:left;” custom_css_toggle_content=”padding:5px 0 10px 20px;” saved_tabs=”all” _i=”7″ _address=”1.2.0.7″]<\/p>\n

We provide testing services of drug microbial limits and bacterial endotoxin, in addition to providing method validation services.<\/p>\n

[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section bb_built=”1″ _builder_version=”3.22″ background_color=”#F4f4f4″ background_image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/07\/bg_pic3.jpg” border_width_bottom=”2px” border_color_bottom=”#cccccc” custom_padding=”10px|0px|10px|0px|false|false” _i=”2″ _address=”2″ prev_background_color=”#ffffff”][et_pb_row _builder_version=”3.26.8″ _i=”0″ _address=”2.0″][et_pb_column type=”4_4″ _builder_version=”3.26.8″ _i=”0″ _address=”2.0.0″][et_pb_button button_url=”\/en\/cro-cdmo-for-nucleic-acid-based-drug\/cro-cdmo-service-for-nucleic-acid-drugs\/” button_text=”Click to quote a CDMO service” button_alignment=”center” _builder_version=”3.27.2″ hover_enabled=”0″ _i=”0″ _address=”2.0.0.0″ \/][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

[et_pb_section bb_built=”1″ _builder_version=”3.27.2″ background_color=”#F2F2F2″ custom_padding=”0px||0px|” z_index_tablet=”500″ box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” _i=”0″ _address=”0″ next_background_color=”#ffffff” global_module=”22006″][et_pb_row global_parent=”22006″ column_structure=”1_3,1_3,1_3″ module_class=”icon_list” _builder_version=”3.25″ custom_padding=”||0px|” _i=”0″ _address=”0.0″][et_pb_column type=”1_3″ global_parent=”22006″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”0.0.0″][et_pb_blurb global_parent=”22006″ url=”\/en\/development\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/icon1_0919.png” module_class=”icon-quick icon-events” _builder_version=”3.27.2″ header_text_align=”center” background_size=”initial” text_orientation=”center” custom_margin=”|||” custom_padding=”|||” animation=”off” hover_enabled=”0″ custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.0.0″ link_option_url=”\/en\/development\/”] Oligonucleotide Manufacturing Process Development [\/et_pb_blurb][et_pb_blurb global_parent=”22006″ url=”\/en\/analytics-and-chemistry-research\/” image=”https:\/\/cdmocmo.ribobio.com\/wp-content\/uploads\/2018\/09\/\u4e34\u5e8a\u7814\u7a76\u7528\u6838\u9178\u836f\u7269\u751f\u4ea7.png” module_class=”icon-quick […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":125,"comment_status":"closed","ping_status":"closed","template":"page-hsy.php","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":""},"_links":{"self":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21594"}],"collection":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/comments?post=21594"}],"version-history":[{"count":8,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21594\/revisions"}],"predecessor-version":[{"id":22106,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21594\/revisions\/22106"}],"wp:attachment":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/media?parent=21594"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}