UK Review and Recommendations on the Procurement of Starting Materials by Apheresis for ATMP Manufacture

To ensure safe, high-quality Advanced Therapy Medicinal Products (ATMPs) are delivered to patients, procurement activities must be standardized when possible. Standardization also supports efficiency and reduces the risk for error while meeting regulatory and accreditation requirements. Download the UK Review and Recommendations on the Procurement of Starting Materials by Apheresis for ATMP Manufacture for insights…

Webinar

International Differences in Cellular Starting Material Quality and Regulatory Requirements

Navigating international differences in 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…

Webinar

Understanding Donor Characteristics to Improve Allogeneic Cell Therapy Outcomes for All

Can donor-reported characteristics, like race and ethnicity, impact data quality for allogeneic cell therapies? That’s one of the questions our expert panelists will discuss during our upcoming webinar. You’ll walk away with a better understanding of:  Efficiencies in donor selection to reduce uncertainties about HLA matching and improve allogeneic cell therapy outcomes  HLA complexity in cell source selection …

Clinical Trials Support

Comprehensive Clinical Trial Support

Cell therapy clinical trials—including those for hematopoietic cell transplantation (HCT)—come with unique challenges and complexity that impact the clinical trial sponsor, investigators, clinical trial sites, physicians, and patients and their caregivers. We offer comprehensive clinical trial services for academic and industry investigators and sponsors, as well as patients, because we know saving more lives through…

Webinar

Leveraging the Experience of Cord Blood Banking in Development of Cellular Therapies

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 cords as an allogeneic cell source for cellular therapy Characteristics and attributes of the existing CBU inventory Importance of managing logistics for delivery of…

Webinar

How Patient Focus Drives Clinical Trial Results: The Intersection of Sponsor, CRO, Site and Patient.

Clinical trial sponsors and CROs have compelling reasons to design an effective clinical trial. You need to not only to answer your research question but also mitigate budget pressures and quickly bring a product to market that addresses patients’ chief complaints. In this webinar you’ll walk away with a better understanding of: Why the voice…