2023-05-24 00:00:00来源：百奥利盟官方发布浏览量：184
2023年第26届美国基因与细胞治疗学会年会(ASGCT)的参会日程圆满结束，百奥利盟作为全球精准医疗和创新生物药数字化解决方案的服务商，聚焦细胞与基因治疗数字化，发布Bio-CELL，Bio-LIMS，Bio-Research，Bio-Bank四个国际版数字化系统，对布局深拓北美市场更加充满信心！本次年会多家来自中国的企业充分彰显中国力量，均在本届大会展示其最新研究进展，涵盖了基因编辑型TIL疗法、基因替代疗法、体内RNA编辑疗法等前沿疗法，多项研究进行了口头报告。
百奥利盟 BioTechLeague | Global Market
百奥利盟 BioTechLeague | Bio LIMS INC
Key Point: 百奥利盟®系统生态全覆盖每个节点（Preclinical Testing, IND Application, Clinical Trials I II III, NDA Application, Approval)，由研发到药品申报直至商业化生产上市，百奥利盟系统（Bio-Research，Bio-Bank，Bio-COI，Bio-QCLIMS, Bio-CELL）均符合且支持药企/医院临床中心发起申报上市路径... ...
不管CAR-T、TILs还是CAR-NK全囊括强调了CoC及CoI基本追溯要求，数字化已然成为趋势。CDE指南愈加细化并强调CoC及CoI基本追溯要求，其中《指南》强调：企业应当建立产品标识和追溯系统，确保在供者材料运输、接收以及产品生产和使用全过程中，来源于不同供者的产品不会发生混淆、差错，确保供者材料或细胞与患者之间的匹配性，且可以追溯。
百奥利盟 BioTechLeague | Bio LIMS INC
Key Point：计算机化系统验证CSV
根据ISPE GAMP5-2配合客户完成计算机化系统验证，可提供中英文验证文件... ...
百奥利盟系统参考并遵守国际行业规范GAMP5和ALCOA+CCEA原则，以及NMPA《药品记录与数据管理要求（试行）》、《GMP附录-细胞治疗产品征求意见稿》相关法规和规范，支持细胞、基因治疗企业临床试验、IND、NDA等计算机系统验证CSV要求且提供双语版功能，从而助力医药企业、科研机构合规化生产管理，降低监管难度，提供国际化接轨支持。
百奥利盟 BioTechLeague | Bio LIMS INC
Key Point: Bio-COI 系统用于身份链追溯，系统根据实际应用场景设置有【医院端】与【生产端】，支持在各个节点记录信息并由对应的人员确认，实现使用一个追溯码就可以完成采样到产品回输的全流程追溯... ...
细胞制备的唯一编码贯穿于细胞全生命周期，从申请单录入开始，经历来样运输、样本接收、生产接收、生产计划、生产、冻存、复苏、传代、外包环节，经过成品放行后最终完成细胞回输，形成可双向追溯的监管链（COC）与身份链（COI）。在放行审核时可回顾细胞生产全过程，快速整理该订单的质控文档与记录，大大提高方形是对产品出场的质量保证。细胞生产制备任务与质检任务双向信息确认，对样本进行质控处理，异常样本进入异常模块，合格样本流入下一步，质量保证贯穿全程，产品检测结束，出具产品检验报告单，进入工作流审批确认，对合格产品放行，对不合格产品出偏差报告。
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
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
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
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
This morning, finish up your time at the meeting with the final oral abstract sessions, symposia, & more!
ASGCT 26th Annual Meeting | Bio LIMS INC
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