I had the honor of interviewing Kyle Cetrulo, CEO of AuxoCell Laboratories. In this interview, we explore the upcoming Future of Regenerative Medicine Congress, as well as future directions for regenerative medicine at large. Enjoy. [Read more…]
Your ULTIMATE Guide to the FDA Public Hearing on “Draft Guidances” Regulating Cells and Tissues (Part 15)
Nearly everyone in the stem cell community knows that there was supposed to be a FDA public hearing on April 13, 2016, related to four draft guidances controlling the regulation of stem cells.
Officially called a public hearing on “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15,” the event was to be held at the FDA White Oak Campus located at 10903 New Hampshire Ave., Bldg. 31, Rm 1503 (Great Room), Silver Spring, MD, 20993.
To enroll for the event, you had to email “[email protected]” with your request to attend, contact information, and whether or not you wished to be a presenter. Whether it was intentional or not, very little time was given for the registration, which ended on on Jan. 8th, 2016, more than three months before the event was scheduled. [Read more…]
Key Market Leaders for Adipose-Derived Mesenchymal Stem Cell (MSC) Storage
In addition to cord tissue storage, many cord blood banks are now investigating the addition of adipose-derived stem cell storage.
It is a logical product extension for cord blood banks, given that a range of collection, processing, and storage equipment is already present within the facility.
Additionally, conversion costs to allow for adipose-derived stem cell storage can be as low as USD $100,000 to $150,000.
The conversion of a cord blood facility to be able to offer adipose-derived stem cell storage can be efficiently accomplished through collaboration with a specialist in the area of adipose tissue extraction and storage.
Companies such as American Cryostem in the United States have been willing to partner with cord blood banks to assist them with adding adipose-derived MSC storage as a service.
Leading Companies Offering Mesenchymal Stem Cell (MSC) Storage
Below is an analysis of both diversified cord blood banks and specialty companies that currently offer adipose-derived stem cell storage. [Read more…]
Are You Planning to Attend FDA’s September 8th Public Workshop on Development of Cellular and Tissue-Based Products?
The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.” [Read more…]
Understand Stem Cell Market Needs, so You Can Precisely Meet Them – with Minimal Time, Cost, and Risk
As a provider of stem cell products and technologies, you know you need to:
- Make effective product development decisions
- Sell more effectively
- Generate improved revenues
- Take market share
Without strategic guidance on which to base your actions, you’re in a difficult position. New products that don’t sell well are costly mistakes. On the other hand, repeatedly launching high-demand products and skillfully addressing the unmet needs of your clients is certain to position you as a market leader.
[Read more…]
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