海角破解版

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Register: On-Demand Ancillary Materials Course

Sign up to access this free on-demand course on ancillary materials.

In this self-paced, virtual course, you will learn about the translational pathway for cell and gene therapies, the ancillary materials qualification process, and considerations for suppliers and manufacturers.

Content Developer Bios

Daniela Mora Ortiz, Scientist, Scientific Support, Epithelial Cell Biology

Daniela Mora Ortiz, Scientist, Scientific Support, Epithelial Cell Biology

Dr. Daniela Mora Ortiz is a Scientist in the Product and Scientific Support department at 海角破解版 Technologies, specializing in epithelial cell biology and cell and gene therapy. She earned her medical degree in Mexico City and completed her specialization in Hematology and Hemotherapy at Hospital Vall d鈥橦ebron in Barcelona, Spain. After her clinical training, she conducted research on pluripotent stem cell differentiation toward hematopoietic lineages and on lung differentiation, gaining expertise in stem cell biology and translational applications. Since joining 海角破解版 in 2017, she has held roles in education, lab management, and scientific support, where she has provided training, advanced technical support, troubleshooting, and consultation to researchers worldwide. In her current role, she supports customers, distributors, and internal teams on epithelial cell biology portfolios while contributing to cross-functional initiatives in cell and gene therapy. She also plays an active role in educational programs, developing and delivering training to enable scientists to advance their research. Over the past two years, she has focused extensively on cell and gene therapy, combining her medical and scientific expertise. Dr. Mora Ortiz is passionate about advancing hematology and epithelial biology research and about enabling scientists to drive innovation in cell and gene therapy.

Josh Woodburn, Manager, Regulatory Affairs

Mina Ordobadi, Regulatory Affairs Specialist, Quality Assurance

Stephanie Hastings, Program Manager, Services for Cell Therapy

Course Curriculum

Session 1: Introduction to the Translational Journey for Cell and Gene Therapies
  • Introduction to Cell and Gene Therapy: Definitions and Examples
  • Potential Applications, Challenges, and Risks Associated with Cell Therapies
  • Basics of Clinical Trial Phases, the Translational Journey, and the Clinical Trial Application Process
  • Ancillary Materials Definition
  • Ancillary Materials in the Cell Manufacturing Processes

Mini Quiz: Test Your Knowledge


Estimated time for completion: 40 minutes

Session 2: Qualification Process for Ancillary Materials
  • Internal Risk Assessment and Guidelines for Qualifying Ancillary Materials
  • Ancillary Materials Safety-by-Design Requirements
  • Ancillary Materials Viral Safety Expectations

Mini Quiz: Test Your Knowledge


Estimated time for completion: 20 minutes

Session 3: Supplier and Manufacturing Considerations
  • Ancillary Material Qualification
  • Working Effectively with Ancillary Materials Suppliers
  • Clinical Customer Case Studies
  • How 海角破解版 Can Support the Use of Its Products as Ancillary Materials in Clinical Applications

Mini Quiz: Test Your Knowledge


Estimated time for completion: 20 minutes

Final Assessment

Complete this final assessment to test your knowledge and receive a certificate following successful completion.


Estimated time for completion: 10 minutes

The on-demand course is divided into 3 sessions and a final assessment. Note that this is not an accredited course and cannot be used to receive Continuing Education (CE) credits. If you wish to take an accredited course, please see our live virtual training.