Sourcing your starting material from healthy, high-quality donors matters when you are manufacturing an allogeneic cell therapy. Any misstep can mean delays in your therapy’s development. Keep these key considerations top of mind as you evaluate whether potential partners have the experience, expertise and relationships required to identify, source and collect your allogeneic donors and…
Considerations for developing scalable and efficient collection network processes The decisions you make when selecting apheresis centers to collect source material for your cell or gene therapy impact your ability to efficiently scale your processes. When your processes and protocols differ from those at an apheresis center, delays can occur. Following best practices can help.…
On-demand webinar offers actionable insights as you develop your protocols. Many crucial considerations impact a cell and gene therapy developer’s apheresis center selection strategy and ability to efficiently scale processes. When collection processes or protocols differ from those in place at a center, there are likely implications for training, forms and standard operating procedures. This…
To identify a sufficient number of donors who meet study eligibility, health authority and medical suitability requirements, a large donor pool is required even for the most common HLA genotypes. Choose a partner whose registry size and diversity are built to scale with you. Discover how accessing the most diverse registry of potential donors in…
View this on-demand webinar for an in-depth discussion of efficiencies in donor selection to reduce uncertainties about HLA matching and improve patient outcomes. A 20-min presentation by Martin Maiers, MS, Vice President of Biomedical Informatics, CIBMTR® (Center for International Blood and Marrow Transplant Research®) is followed by a 40-min Q&A session featuring the following well-known…
A client initiated a Phase I clinical trial for its allogeneic cell therapy. Several months in, limited success recruiting patients had led to an expensive lack of progress. The client engaged with the CIBMTR® Bioinformatics Consulting team through NMDP BioTherapies℠ to identify U.S. states and counties with the highest density of patients and donors with…
This on-demand webinar helps answer the question, “What constitutes quality allogeneic cell therapy starting material and how you can ensure it?” The webinar explores specific risks and practical downstream repercussions of insufficient and variable starting material quality. Our expert panelists discuss how to help ensure both high-quality and consistent cellular starting material by building efficiencies…
Navigating international regulations for cellular starting material is complex. This is particularly true because the rapid advancement of the industry sometimes precedes regulatory guidance. When you’re procuring cellular starting material or distributing a cell or gene therapy product across international borders, you must consider the country or regional requirements at play and where they diverge.…
Along with gaining insights into how to tap into the expertise of cord blood banks and access therapy-matched cord blood units (CBUs), you’ll get a better understanding of: Comprehensive benefits of cord blood as an allogeneic cell source for cellular therapy Characteristics and attributes of the existing cord blood inventory Importance of managing logistics for…