YouTube’s First Live Hair Transplant Attracts Record-Breaking 70,000 Viewers

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Hair Restore ProcedureLeading hair restoration physician and HypoThermosol user Dr. Alan J. Bauman and YouTube Celebrity Kevin “Nalts” Nalty draw largest audience in history, spark new consumer interest with recent hair transplant webcast.

Over 70,000 consumers tuned in to the first ever YouTube Live hair transplant on November 18, as renowned hair restoration physician Alan J. Bauman, M.D. performed a second NeoGraft Follicular-Unit Extraction (FUE) on weblebrity Kevin “Nalts” Nalty. The live hair transplant surgery was broadcasted live on YouTube’s new, interactive webcast platform, YouTube Live, and simulcasted on Spencer Kobren’s The Bald Truth radio show, Andrew Zarian’s GFQ web radio network, Ustream, JustinTV, Switcher radio, iTunes radio and other outlets.

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Why BioLife customer Athersys chose HypoThermosol

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Athersys is developing MultiStemTM, a proprietary adult stem cell product currently being using in multiple clinical trials including Phase I and II trials in indications of Acute Myocardial Infarction, transplant support (Graft Versus Host Disease prophylaxis), Ulcerative Colitis and Stroke. MultiStem is a cell therapy product derived from the bone marrow of a healthy donor.

Extended Final Dose Stability. »

Use of Cryostor in Manufacturing of a Dendritic Cell Vaccine Platform

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DCPrime B.V. (DCPrime) is a Dutch biotechnology company which develops a novel approach for making cancer vaccines. DCPrime holds a unique platform technology based upon a sustainable dendritic progenitor cell line (DCOne™).

Upon loading with cancer antigens, this generates off-the-shelf DC-based therapeutic products that stimulate a cancer patient’s immune system to recognize and destroy cancer antigens. DCOne combines the power of DC-based vaccines with the advantages of allogeneic immune stimulation, with simpler off-the-shelf clinical logistics. With this powerful platform, DCPrime is developing the next generation of cancer vaccines.

Three years frozen, identical to starter cells »

Intercytex CEO: “HypoThermosol clearly outperformed other hypothermic storage media.”

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Intercytex

Evaluation of VAVELTA® Burns, Wound Scarring, and a Genetic Skin Disorder

Intercytex is funded in part by a series of grants from the North West Development Agency, the UK Government’s Technology Strategy Board, the European Union and by an agreement with the US Department of Defense as well as private investment. Intercytex Ltd is focused on developing and marketing VAVELTA to ensure its potential and benefits can be realized.

VAVELTA (ICX-RHY) is a proprietary suspension of human dermal fibroblasts (naturally derived skin cells) in HypoThermosol cell storage medium, for injection into the skin. VAVELTA is thought to repair the extracellular matrix to improve skin structure and function. VAVELTA is designated as one of the first Advanced Therapy Medicinal Products (ATMP) by the European Medical Agency and has already been used in clinical trials and compassionate use programs in over 100 patients in a variety of indications.

Several hypothermic storage solutions considered. »

Optimizing Manufacturing of Hospital-Based Cellular Therapies to Support Clinical Trials

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City of Hope is recognized worldwide for its compassionate patient care, innovative science and translational research, which rapidly turns laboratory breakthroughs into promising new therapies.

We are one of only 40 National Cancer Institutedesignated Comprehensive Cancer Centers nationwide and a founding member of the National Comprehensive Cancer Network. An independent biomedical research, treatment and education institution, we are a leader in the fight to conquer cancer, diabetes, HIV/AIDS and other life-threatening diseases.

Why we chose CryoStor. »

Cell Therapy: Biopreservation Stability Considerations (Part 1 of 4)

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Advanced Cell Therapy

Scott Burger, MD

This is part one of a four-part series from Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC.

I. IMPACT OF STABILITY
Raw material and finished product stability, or shelf-life, is a crucial factor in development and commercialization of biologic-based products.

You want extended cell stability. It impacts nearly all aspects of operations, from manufacturing and logistics to patient scheduling and ease of use (Table 1). Stability considerations drive a variety of critical decisions, from location and number of manufacturing sites to transportation methods.

See Table 1: Points of Influence of Stability. »

Cell Therapy: Biopreservation Stability Considerations (Part 2 of 4)

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Advanced Cell Therapy

Scott Burger, MD

This is part two of a four-part series from Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC.

II. ENHANCING STABILITY – CRYOPRESERVATION
Cryopreservation can greatly extend cell stability, often for years, and simplify certain aspects of operations. Product release can be performed after all testing has been completed, with products stored until needed, and administration scheduled with maximum flexibility.

The benefits of cryopreservation do not come without difficulties of their own, however. Transportation of cryopreserved products can be costly and adds operational complexity.

What’s the problem with post-thaw processing? »

Cell Therapy: Biopreservation Stability Considerations (Part 3 of 4)

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Advanced Cell Therapy

Scott Burger, MD

This is part three of a four-part series from Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC.

III. ENHANCING STABILITY – HYPOTHERMIC STORAGE
Hypothermic storage is a simpler and perhaps more broadly applicable method to achieve extended cell stability.

Cells maintained in the presence of an effective hypothermic preservation agent at 2-8°C can increase stability by days or weeks, with varying results obtained with different cell types (see Mathew, et. al.) – some more than others.

See the (major) difference in efficacy. »

Cell Therapy: Biopreservation Stability Considerations (Part 4 of 4)

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Advanced Cell Therapy

Scott Burger, MD

This is part four of a four-part series from Scott Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC.

IV. NEW REAGENTS, NEW METHODS – EFFECTIVE PROCESS MODIFICATION
Changing to a new biopreservation solution, like any manufacturing process modification, raises questions about unintended effects on the product.

These can be addressed by a validation study incorporating rigorous characterization testing to compare products manufactured using the original and modified biopreservation processes. Testing should include product purity and identity characterization parameters, as well as the relevant biological function, i.e., potency.

Introducing and validating a new reagent or process step does not invalidate the original process. In fact, the opposite is true.

Mesh constructs and Hydrogels »

Biopreservation Economics

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BioLife CEO Mike Rice

BioLife CEO Mike Rice

The materials and methods used in the biopreservation of source material, intermediate derivatives, and finished cell therapy products greatly influence several critical success factors for final product development and commercialization.

The Cost Per Delivered Dose of a cell therapy product (arguably the most important metric once safety and efficacy are proven) is driven by a yield-cost relationship throughout the biopreservation system. Relationship components include the cost, yield, and stability of source material, as well as the concentration, volume, potency, toxicity, and stability of the finished product.

Increase your yield. »

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