BioLife Solutions Inc.

Ian B. Nicoud, Ph.D

TISSUE COLLECTION AND STORAGE FOR PROCESSING

The use of these solutions greatly advanced the field of organ transplantation. Its success has prompted the development and use of optimized biopreservation solutions for collection, storage, and transport of other biologic materials, including tissues and cells.

The need for extended cell storage times with improved recovery and viability of biologic source material and derived/isolated cells has been driven largely by the growth of the regenerative medicine market. Because specimens are often shipped among collection, processing, and clinical sites, maintaining therapeutic quality and quantity is paramount. The number of available doses, their potency, and efficacy of the delivered therapy can all be affected by the robustness of the biopreservation media and processes utilized.

Links to downloadable studies. »

Making your own biopreservation media may be costing you more than you realize!

Biopreservation of cells, tissues, and organs is a frequently applied and required practice used to extend the stability and viability in both short-term and long-term storage of samples for research and clinical applications.

Outside of storing cells at normothermic temperatures (37°C growth conditions), most practitioners utilize either hypothermic biopreservation or cryopreservation methods.

Hypothermic biopreservation is typically performed at temperatures above 0°C and usually between 2-10°C, but certainly below ambient (around 22°C) or normothermic conditions. It is used for short-term transport and storage, during which metabolic activity is greatly reduced but still present at some level.

Cryopreservation, or frozen storage, involves long-term storage of biologics at or below -80°C (typically below -140°C) in conditions of metabolic arrest.

What is the True Cost? »

Summary of Experimental Groups (Click to enlarge)

A study to collect quantitative data to better characterize the safety profile of HypoThermosol and CryoStor from BioLife.

The FDA or other agencies do not regulate biopreservation media products as drugs, devices, biologics, or combination products.

• They are considered “ancillary material” when used in the manufacturing of cell, gene, or tissue-engineered products, but are not intended to be in final product (washed or removed).
• Or they are considered “excipient components” intended to be part of the final product and in contact with the patient.

The results come in. »

Although the commercial history of cell therapy is not as extensive as the broader biotherapeutic market, a number of parallels can be drawn between the two.

In the early 1980’s it was clear to many scientists that commercially manufactured therapeutic grade antibodies could have a significant benefit if used as ligand-mimetic agonists or antagonists of important signaling pathways.

Lot sizes upwards of 8 billion cells per product run. »

Progenitor Cell Therapy (PCT) is an internationally recognized commercial client-oriented service company, with a long-term commitment to the development, manufacturing and commercialization of effective cell therapies, as the emerging paradigm for the treatment of disease.

Cost-effective turnkey service solutions. »

PharmaCell operates a stateof- the-art cGMP-Licenced facility for human cell and tissue culturing located centrally in Europe. We are the CMO of choice to leading biotech companies in the field of cell therapy and regenerative medicine and are one of very few companies in Europe to hold an official licence as a Registered Tissue Establishment.

The Netherlands’ Official Registered Tissue Establishment. »