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.
    July 29, 2015

    Technology Transfer in Cell Therapy Manufacturing: Critical Aspects for Success

    Below is an excerpt on technology transfer in cell therapy manufacturing, written by Catherine McIntyre, PhD, Director, Technical Operations, and Cenk Sumen, PhD, ...

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    July 27, 2015

    Development by Design Principles in Cell Therapy Manufacturing

    As discussed in my previous post, FDA has provided guidance via ICH Q8 for pharmaceutical development (where Quality by Design (QbD) principles are presented) for ...

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    July 14, 2015

    Understanding Technology Transfer, a Critical Aspect of Cell Therapy Manufacturing

    Below is an excerpt on technology transfer in cell therapy manufacturing originally published in the April 2015 issue of BioProcess International as part of the article, ...

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    October 23, 2012

    Beyond Scale-up, Part 4 of 4: Delivery Method Effect on Resource Demand

    By Sanjin Zvonic, PhD, Director, Technology & Business Development

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