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.

January 29, 2018

How Does Cryopreservation Affect Quality Control of Cell Therapies

One of the major challenges of delivering a patient-specific cell therapy is that fresh cells for modification are usually only viable for about one to three days from ...

January 9, 2018

5 Considerations in the Preparation for Commercializing Cell Therapy

Cell therapy is still a relatively new form of treatment. As such, not that many cell therapies have successfully reached commercialization. Meeting FDA requirements at ...

January 5, 2018

What Nobody Tells You About Cell Therapy cGMP Manufacturing

PCT services have helped many companies and research organizations develop their cell therapies from early-stage clinical trials into products ready for ...

January 3, 2018

Optimizing Cost of Goods for Cell Therapy Manufacturing

The cost of goods (COGs) to manufacture a cell therapy can have an enormous impact on the long-term viability and sustainability of the therapy as a commercialized ...

December 20, 2017

The Calculus for Success and the Nature of Innovation in the Cell Therapy Industry

As I contemplate the future landscape of this cell and gene-based medicine industry and how best it can be navigated, I am always less certain of precisely what the ...

November 2, 2017

Robert Preti, PhD, Opens the 2017 Cell & Gene Meeting on the Mesa

At this year's Cell & Gene Meeting on the Mesa, Robert Preti, PhD, Chairman of the Alliance for Regenerative Medicine and President and CEO of Hitachi Chemical ...

August 31, 2017

What to Look for in a Trusted cGMP Manufacturing Partnership

Taking a new cell therapy from early clinical trials all the way to commercial manufacturing is a long and difficult process that few have completed to date. There are ...

August 30, 2017

Phase Appropriate Quality vs. Development by Design

Developing a new cell therapy is a long and arduous process. Many cell therapies fail to clear all of the obstacles on the road to commercialization. When considering ...

August 15, 2017

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 ...

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