Insights

Security and Supply of Blood Derived Ancillary Materials May Need to Be Rethought in the Era of Novel Viral Outbreaks: A Webinar Hosted by HCATS & Sexton Biotechnologies

Improving Starting Material Stability for Cell Therapy Manufacturing

The quality and consistency of starting material can have an enormous impact on downstream manufacturing processes in cell therapy. Recently, Hitachi Chemical partnered ...

Developing & Managing Therapeutic Cell Collection Networks

The quality of starting materials can have an enormous impact on the potency, purity, and safety of a cell therapy product. Flaws in the collection or transportation ...

5 Signs You Might Not Be Ready for a Cell Therapy Technology Transfer

A technology transfer (“tech transfer”) for cell therapy manufacturing is the transfer of knowledge, experience, specifications, procedures, and data for manufacture of ...

Why Would You Want to Perform a Technology Transfer

In a recent article, we discussed some of the major telltale signs that your cell therapy product might not be ready for a technology transfer. To be successful, a cell ...

Product Stewardship Throughout Your Cell Therapy Clinical Development

Product stewardship is a vital part of any cell therapy technology transfer and/or clinical development. The basic definition of product stewardship is the technical ...

Reviewing Biomanufacturing for Clinically Advanced Cell Therapy Products

Hitachi Chemical Advanced Therapeutics Solutions (HCATS) is proud to be an active contributor to the scientific research and publications surrounding the regenerative ...

What You Need to Know About Cell-Based Therapy Regulations in the United States

From helping prepare clients' cell therapy products for commercial-scale manufacturing to troubleshooting test methods for compliance with cGMP and cGTP regulations, ...

Why Autologous and Patient-Specific Aren’t the Same in Cell Therapy

When referring to cell therapy, precision in your use of terminology is crucial for technical accuracy and reporting. There are many terms that have similar meanings but ...