{"id":21618,"date":"2018-07-18T14:47:55","date_gmt":"2018-07-18T06:47:55","guid":{"rendered":"https:\/\/cdmocmo.ribobio.com\/commercial-oligonucleotides-api-manufacture\/"},"modified":"2019-08-23T19:04:44","modified_gmt":"2019-08-23T11:04:44","slug":"commercial-oligonucleotides-api-manufacture","status":"publish","type":"page","link":"https:\/\/cdmocmo.ribobio.com\/en\/commercial-oligonucleotides-api-manufacture\/","title":{"rendered":"Manufacture for Commercial"},"content":{"rendered":"

[et_pb_section fb_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” global_module=”22006″ bb_built=”1″ _i=”0″ _address=”0″][et_pb_row 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″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”0.0.0″][et_pb_blurb 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” link_option_url=”\/en\/development\/” custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.0.0″]<\/p>\n

Oligonucleotide Manufacturing Process Development<\/h6>\n

[\/et_pb_blurb][et_pb_blurb 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” link_option_url=”\/en\/analytics-and-chemistry-research\/” custom_css_after=”background:#f00|| ” _i=”1″ _address=”0.0.0.1″]<\/p>\n

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

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

[\/et_pb_blurb][et_pb_blurb 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” link_option_url=”\/en\/commercial-oligonucleotides-api-manufacture\/” custom_css_after=”background:#f00|| ” _i=”1″ _address=”0.0.1.1″]<\/p>\n

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

[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”2″ _address=”0.0.2″][et_pb_blurb 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” link_option_url=”\/en\/drug-product-fill-and-finish\/” custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.2.0″]<\/p>\n

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

[\/et_pb_blurb][et_pb_blurb 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” link_option_url=”\/en\/quality-management-system\/” custom_css_after=”background:#f00|| ” _i=”1″ _address=”0.0.2.1″]<\/p>\n

Validation & Quality<\/h6>\n

[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”54px|0px|11px|0px” bb_built=”1″ _i=”1″ _address=”1″][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

\"\"Oligonucleotide Manufacturing for Commercial Phases<\/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\/api_banner-1.jpg” align_tablet=”center” align_last_edited=”on|desktop” _builder_version=”3.23″ custom_padding=”|0px||0px” _i=”0″ _address=”1.1.0.0″][\/et_pb_image][\/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

RiboBio is widely praised by customers for its experience in oligonucleotide-based CMC services – Chemistry, Manufacturing and Control. In 2013, RiboBio became the first to establish a large-scale oligonucleic acid cGMP manufacturing workshop in China; in 2016, it obtained the CFDA-issued API production license; in 2018, it completed the construction of the workshop, and the facility will be launched in 2019 for 1800nmol mass synthesis per batch and 1kg-40kg lyophilization, meeting the commercial production requirements of APIs above the kilogram level. RiboBio also provides process validation, analytical methods, quality assurance and risk management.<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”3.27.2″ text_text_color=”#1e73be” custom_margin=”||4px|” custom_margin_last_edited=”on|desktop” custom_padding=”||0px|0px” custom_padding_last_edited=”off|phone” z_index_tablet=”500″ text_text_shadow_horizontal_length_tablet=”0px” text_text_shadow_vertical_length_tablet=”0px” text_text_shadow_blur_strength_tablet=”1px” link_text_shadow_horizontal_length_tablet=”0px” link_text_shadow_vertical_length_tablet=”0px” link_text_shadow_blur_strength_tablet=”1px” ul_text_shadow_horizontal_length_tablet=”0px” ul_text_shadow_vertical_length_tablet=”0px” ul_text_shadow_blur_strength_tablet=”1px” ol_text_shadow_horizontal_length_tablet=”0px” ol_text_shadow_vertical_length_tablet=”0px” ol_text_shadow_blur_strength_tablet=”1px” quote_text_shadow_horizontal_length_tablet=”0px” quote_text_shadow_vertical_length_tablet=”0px” quote_text_shadow_blur_strength_tablet=”1px” header_text_shadow_horizontal_length_tablet=”0px” header_text_shadow_vertical_length_tablet=”0px” header_text_shadow_blur_strength_tablet=”1px” header_2_text_shadow_horizontal_length_tablet=”0px” header_2_text_shadow_vertical_length_tablet=”0px” header_2_text_shadow_blur_strength_tablet=”1px” header_3_text_shadow_horizontal_length_tablet=”0px” header_3_text_shadow_vertical_length_tablet=”0px” header_3_text_shadow_blur_strength_tablet=”1px” header_4_text_shadow_horizontal_length_tablet=”0px” header_4_text_shadow_vertical_length_tablet=”0px” header_4_text_shadow_blur_strength_tablet=”1px” header_5_text_shadow_horizontal_length_tablet=”0px” header_5_text_shadow_vertical_length_tablet=”0px” header_5_text_shadow_blur_strength_tablet=”1px” header_6_text_shadow_horizontal_length_tablet=”0px” header_6_text_shadow_vertical_length_tablet=”0px” header_6_text_shadow_blur_strength_tablet=”1px” box_shadow_horizontal_tablet=”0px” box_shadow_vertical_tablet=”0px” box_shadow_blur_tablet=”40px” box_shadow_spread_tablet=”0px” _i=”1″ _address=”1.2.0.1″]<\/p>\n

\u25cf   Mass production process transfer, certification and verification<\/a><\/strong><\/p>\n

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\u25cf \u00a0 Transfer and verification of analytical methods<\/strong><\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”3.26.8″ text_font=”||||||||” custom_margin=”||4px|” custom_margin_last_edited=”on|desktop” custom_padding=”||0px|20px” custom_padding_phone=”||0px|0px” custom_padding_last_edited=”off|phone” _i=”3″ _address=”1.2.0.3″]<\/p>\n

We develop analysis methods for product purity, related substances, water constituent, elemental impurities, sodium salts, residual solvents, contents, microbial limits, and bacterial endotoxin in different oligonucleotide products according to customer requirements, and verifiy these analytical methods to make them truly meet nucleotide and drug testing and quality control requirements. We also transfer these methods to customers based on pharmacopoeia requirements for further optimization and verification.<\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”3.26.8″ text_text_color=”#1e73be” custom_margin=”||4px|” custom_margin_last_edited=”on|desktop” custom_padding=”||0px|0px” custom_padding_phone=”||0px|0px” custom_padding_last_edited=”off|phone” _i=”4″ _address=”1.2.0.4″]<\/p>\n

\u25cf \u00a0 Commercial oligonucleotide-based drugsc GMP manufacturing<\/strong><\/p>\n

[\/et_pb_text][et_pb_text _builder_version=”3.26.8″ custom_margin=”||4px|” custom_margin_last_edited=”on|desktop” custom_padding=”||0px|20px” custom_padding_phone=”||0px|0px” custom_padding_last_edited=”off|phone” _i=”5″ _address=”1.2.0.5″]<\/p>\n

RiboBio has introduced an automated oligo synthesis platform for the large single-batch synthesis, and established a world-class oligonucleotide API production line according to GMP requirements, with a synthesis scale at 1.8M and 40kg oligonucleotide API in a single batch.<\/p>\n

In 2012, RiboBio established China’s first oligonucleotide API base under cGMP condition. It was designed by globally renowned consultants, and was qualified by Guangdong Provincial Institute of Drug Control. The production base has obtained Production License issued by CFDA.<\/p>\n

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\u25cf   cGMP Quality Management System<\/a><\/strong>
\u25cf   Project & Risk Management<\/a><\/strong>
\u25cf   Facility verification<\/a><\/strong><\/p>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_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” global_module=”21939″ bb_built=”1″ _i=”2″ _address=”2″][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-service-for-nucleic-acid-drugs\/” button_text=”Quote for CDMO service” button_alignment=”center” _builder_version=”3.26.8″ _i=”0″ _address=”2.0.0.0″][\/et_pb_button][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

[et_pb_section fb_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” global_module=”22006″ bb_built=”1″ _i=”0″ _address=”0″][et_pb_row 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″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||” _i=”0″ _address=”0.0.0″][et_pb_blurb 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” link_option_url=”\/en\/development\/” custom_css_after=”background:#f00|| ” _i=”0″ _address=”0.0.0.0″] Oligonucleotide Manufacturing Process Development [\/et_pb_blurb][et_pb_blurb 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” […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":127,"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\/21618"}],"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=21618"}],"version-history":[{"count":12,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21618\/revisions"}],"predecessor-version":[{"id":22101,"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/pages\/21618\/revisions\/22101"}],"wp:attachment":[{"href":"https:\/\/cdmocmo.ribobio.com\/en\/wp-json\/wp\/v2\/media?parent=21618"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}