细胞和基因治疗解决方案

通过细胞和基因治疗的专业专业知识,临床前临床和批准阶段的协调能力和有影响力创新,我们将帮助您减少治疗性发展中的时间和风险。

  • Supported development of both FDA approved CAR-T therapies

  • Helped to advance the first two FDA approved gene replacement therapies

  • More than 20 years of delivering development solutions for cell and gene therapies

细胞和基因治疗中心
Your Needs

开发细胞或基因治疗是一种独特的复杂过程,需要专门的科学,监管和后勤见解和能力。Whether you’re developing a viral (such as AAV) or nonviral-based gene therapy, an adoptive or autologous cell therapy, a stem cell therapy or other type of regenerative medicine, your program will face challenges that can delay or even derail your therapeutic’s development.

Overcome these challenges with the help of the Covance cell and gene therapy team and its coordinated, global capabilities that offers unparalleled technical, regulatory and commercialization expertise. Coupled with our program management, consultation and renowned capabilities in biomarkers and companion diagnostics, you can obtain comprehensive, integrated solutions that address the unique needs of your program.

通过使用一个CRO合作伙伴,您可以修剪您的开发时间表,简化已复杂的程序,并减轻跨多个供应商拆分程序固定的潜在风险。此外,随着许多快速的监管审查和批准途径,如再生医学的先进治疗(RMAT)指定,可能是一个压缩和缩短的开发计划。让我们帮助您对齐并优化您的开发计划,并为您的计划创造长期的战略愿景,以加速您的细胞和基因治疗的发展。

保持在细胞和基因疗法动态领域的曲线领先,需要对人们,流程和技术进行持续投资。为了帮助确保您的细胞和基因治疗方案继续有效且有效地推进,Covance已形成战略伙伴关系,使重点收购并投入许多有影响力的创新,以留在细胞和基因治疗发展的最前沿。

细胞和基因疗法还需要专门的治疗和专业领域专业知识,特别是rare diseases,xinyabo体育app,oncology免疫肿瘤学。了解有关我们如何减轻风险的更多信息,加快您的开发计划,并提供各地设计的精密药品解决方案®

我们的能力

细胞和基因疗法已经对患者的生命产生了深远的影响,并且有可能影响更多。Whether you’re using CRISPR/cas9 for gene editing to develop a gene replacement therapy, engineering a CAR-T cell therapy or developing other innovative product types, you’ll benefit from our cross-functional capabilities that span early development to the clinic to commercialization and post-approval testing.

Key Highlights:

  • 每个阶段和跨越连续体的专业知识
  • Coordinated capabilities from one partner
  • 专注于细胞和基因治疗发展的投资
Enterprise Solutions
  • yaboapp体育官网临床前,临床,实验室,批准后解决方案
  • Gene Therapies, Gene-modified Cell Therapies, Adoptive T-cell Therapies, etc.
  • 罕见疾病,儿科,肿瘤学和免疫肿瘤学
  • 科学战略和执行
  • 计划咨询和管理
  • 法规
  • Commercialization
  • Biomarkers and Companion Diagnostics

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  • In vitro&in vivo药理& Toxicology
  • Bioanalysis: distribution, persistence & shedding
  • Biomarkers
  • 法规& Strategic Product Development Consulting
  • 临床Development Preparation
  • CMC分析Testing
  • Commercialization Strategy

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  • 临床研究,肿瘤学专业知识,稀有疾病和儿科
  • 法规& Strategic Product Development Consulting
  • 生物标志物,包括伴侣诊断
  • 中央实验室
  • Bioanalysis: distribution, persistence & shedding
  • CMC分析Testing
  • Commercialization Strategy

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  • Post-marketing Commitments, including long term follow-up
  • Real World Evidence
  • 药剂纲素
  • 患者支持和呼叫中心
  • 法规& Strategic Product Development Consulting
  • 通过专业测试Labcorp.
  • CMC分析Testing