摘要：

2023年第26屆美國基因與細胞治療學(xué)會年會(ASGCT)的參會日程圓滿結(jié)束，百奧利盟作為全球精準醫(yī)療和創(chuàng)新生物藥數(shù)字化解決方案的服務(wù)商，聚焦細胞與基因治療數(shù)字化，發(fā)布Bio-CELL，Bio-LIMS，Bio-Research，Bio-Bank四個國際版數(shù)字化系統(tǒng)，對布局深拓北美市場更加充滿信心！本次年會多家來自中國的企業(yè)充分彰顯中國力量，均在本屆大會展示其最新研究進展，涵蓋了基因編輯型TIL療法、基因替代療法、體內(nèi)RNA編輯療法等前沿療法，多項研究進行了口頭報告。

百奧利盟 BioTechLeague | Global Market

Bio LIMS INC，F(xiàn)ocus on 細胞與基因治療數(shù)字化，為CGT產(chǎn)業(yè)化提供符合COI（身份鏈）、COC（監(jiān)管鏈）標準的解決方案，無縫拓展到研發(fā)、細胞生產(chǎn)、質(zhì)控數(shù)字化

百奧利盟 BioTechLeague | Bio LIMS INC

Key Point: 百奧利盟?系統(tǒng)生態(tài)全覆蓋每個節(jié)點（Preclinical Testing, IND Application, Clinical Trials I II III, NDA Application, Approval)，由研發(fā)到藥品申報直至商業(yè)化生產(chǎn)上市，百奧利盟系統(tǒng)（Bio-Research，Bio-Bank，Bio-COI，Bio-QCLIMS, Bio-CELL）均符合且支持藥企/醫(yī)院臨床中心發(fā)起申報上市路徑... ...

不管CAR-T、TILs還是CAR-NK全囊括強調(diào)了CoC及CoI基本追溯要求，數(shù)字化已然成為趨勢。CDE指南愈加細化并強調(diào)CoC及CoI基本追溯要求，其中《指南》強調(diào)：企業(yè)應(yīng)當建立產(chǎn)品標識和追溯系統(tǒng)，確保在供者材料運輸、接收以及產(chǎn)品生產(chǎn)和使用全過程中，來源于不同供者的產(chǎn)品不會發(fā)生混淆、差錯，確保供者材料或細胞與患者之間的匹配性，且可以追溯。

百奧利盟 BioTechLeague | Bio LIMS INC

Key Point：計算機化系統(tǒng)驗證CSV

根據(jù)ISPE GAMP5-2配合客戶完成計算機化系統(tǒng)驗證，可提供中英文驗證文件... ...

百奧利盟系統(tǒng)參考并遵守國際行業(yè)規(guī)范GAMP5和ALCOA+CCEA原則，以及NMPA《藥品記錄與數(shù)據(jù)管理要求（試行）》、《GMP附錄-細胞治療產(chǎn)品征求意見稿》相關(guān)法規(guī)和規(guī)范，支持細胞、基因治療企業(yè)臨床試驗、IND、NDA等計算機系統(tǒng)驗證CSV要求且提供雙語版功能，從而助力醫(yī)藥企業(yè)、科研機構(gòu)合規(guī)化生產(chǎn)管理，降低監(jiān)管難度，提供國際化接軌支持。

百奧利盟 BioTechLeague | Bio LIMS INC

Key Point: Bio-COI 系統(tǒng)用于身份鏈追溯，系統(tǒng)根據(jù)實際應(yīng)用場景設(shè)置有【醫(yī)院端】與【生產(chǎn)端】，支持在各個節(jié)點記錄信息并由對應(yīng)的人員確認，實現(xiàn)使用一個追溯碼就可以完成采樣到產(chǎn)品回輸?shù)娜鞒套匪?.. ...

細胞制備的唯一編碼貫穿于細胞全生命周期，從申請單錄入開始，經(jīng)歷來樣運輸、樣本接收、生產(chǎn)接收、生產(chǎn)計劃、生產(chǎn)、凍存、復(fù)蘇、傳代、外包環(huán)節(jié)，經(jīng)過成品放行后最終完成細胞回輸，形成可雙向追溯的監(jiān)管鏈（COC）與身份鏈（COI）。在放行審核時可回顧細胞生產(chǎn)全過程，快速整理該訂單的質(zhì)控文檔與記錄，大大提高方形是對產(chǎn)品出場的質(zhì)量保證。細胞生產(chǎn)制備任務(wù)與質(zhì)檢任務(wù)雙向信息確認，對樣本進行質(zhì)控處理，異常樣本進入異常模塊，合格樣本流入下一步，質(zhì)量保證貫穿全程，產(chǎn)品檢測結(jié)束，出具產(chǎn)品檢驗報告單，進入工作流審批確認，對合格產(chǎn)品放行，對不合格產(chǎn)品出偏差報告。

ASGCT 精彩回顧

The First Day of the Annual Meeting!- May 16, 2023

Today: Watch the first oral abstract presentations, and hear from recipients of the Founders and Catalyst Awards.

ASGCT 26th Annual Meeting | Bio LIMS INC

Founders and Catalyst Award Lectures

3:45 - 5:30 p.m.
West Hall B

The Maturation of Hematopoietic Stem Cell Gene Therapy: Of Mice and Men
David A. Williams, MD

It's All About the Dose
Joy Cavagnaro, PhD

#ASGCT23 Day Two: The Exhibit Hall Opens This Morning -May 17, 2023

Today at the Annual Meeting: First day to visit the Exhibit Hall, attend the Outstanding Achievement Award and Presidential Symposia

ASGCT 26th Annual Meeting | Bio LIMS INC

Exhibit Hall Open

West Hall A
9:45 a.m. - 7 p.m.

Visit booths from 270 companies in the Exhibit Hall!

Outstanding Achievement Award Symposium

West Hall B
10:15 a.m. - 12 p.m.

J. Keith Joung, MD, PhD -?Gene Editing Voyages from Z to C (Zinc fingers to CRISPR)

Bruce L. Levine, PhD -?Translating T Cell Therapies From Boutique to Global (Inveniemus Aut Faciemus)

Isabelle Riviere, PhD -?Building a highway for CARs

Mark Dudley, PhD -?One Patient, One Product - The Development of Adoptive T-cell Therapy

Presidential Symposium + Presentation of Top Abstracts

West Hall B
1:30 - 3 p.m.

Jennifer Doudna, PhD -?CRISPR Chemistry and Applications in the Clinic

David R. Liu, PhD -?Base Editing and Prime Editing: Correction Mutations that Cause Genetic Disease in Cells, Animals, and Patients

Drs. Stanley Riddell, Crystal Mackall at the George Stam Lecture - May 18, 2023

We're also looking forward to more symposia and oral abstracts, the second day of the Career Fair, and the first-ever Women in Gene + Cell Therapy reception.

ASGCT 26th Annual Meeting | Bio LIMS INC

George Stamatoyannopoulos Memorial Lecture and Award Presentation

West Hall B
10:15 a.m.-12 p.m.

Stanley Riddell, MD -?Realizing the Potential of Genetically Engineered Immune Cells in Cancer Therapy

Crystal Mackall, MD -?Expanding the Reach and Efficacy of CAR T Cell Therapies

Watch Our First Late-Breaking Abstract Presentations - May 19, 2023

Grab an early breakfast with the Global Outreach Committee. Later, help us recognize our Outstanding New Investigator Award recipients!

ASGCT 26th Annual Meeting | Bio LIMS INC

Enjoy the Final Day of #ASGCT23! - May 20, 2023

This morning, finish up your time at the meeting with the final oral abstract sessions, symposia, & more!

ASGCT 26th Annual Meeting | Bio LIMS INC

來源：www.asgct.org