Insights

Minaris Regenerative Medicine’s leaders and experts are proud to share their knowledge and insight with the cell and gene therapy industry. Please review our current and past blog posts on topics of interest to this emerging industry.

*This page may include mention of our past company names as it reflects content distributed in the past. The former companies Hitachi Chemical Advanced Therapeutics Solutions (HCATS, formerly PCT or PCT Cell Therapy Services), apceth Biopharma GmBH are all now operations under the name Minaris Regenerative Medicine. Hitachi Chemical Co., Ltd. has been renamed Showa Denko Materials Co., Ltd.

September 30, 2018

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 ...

September 27, 2018

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 ...

September 13, 2018

Think Beyond Cleanrooms for a Commercially-Sustainable Future

Maintaining a sterile environment is an absolute must for maintaining product sterility in cell therapy manufacturing. Although the cost of building cleanrooms has ...

September 6, 2018

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 ...

August 30, 2018

Is Scalability Possible for Patient-Specific Cell Therapy?

The traditional method of achieving scale in manufacturing is, typically, to increase production capacity so that more product can be sold. For example, with medicines ...

July 16, 2018

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 ...

July 5, 2018

Demonstrating Scalable T-Cell Expansion in Stirred-Tank Bioreactors

Cell therapy products have started to gain significant traction in the pharmaceutical industry in the last few years because of the potential they possess to treat many ...

April 23, 2018

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, ...

March 20, 2018

[The Cell Culture Dish Podcast] Opportunities and Challenges in Cell Therapy Manufacturing

Dr. Robert Preti joins The Cell Culture Dish in advance of his upcoming keynote at CBI's Optimization of Cell and Gene Therapy Production Conference. The Cell Culture ...

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