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Biopreservation Best Practices for Regenerative Medicine GMP Manufacturing & Focus on Optimized Biopreservation Media

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Biopreservation Best Practices for Regenerative Medicine GMP Manufacturing & Focus on Optimized Biopreservation Media CELL & GENE THERAPY INSIGHTS LATEST ADVANCES IN ADDRESSING BIOPRESERVATION CHALLENGES INNOVATOR INSIGHT Biopreservation Best Practices for regenerative medicine GMP manufacturing & focus on optimized biopreservation media Brian J Hawkins, Alireza Abazari & Aby J Mathew Cellular therapies are cell and tissue products sourced from biological materials that are employed as ‘living drugs.’ Such ‘living drugs’ require specialized biological support, namely biopreservation, to maintain op- timal recovery, viability and return to function post-preservation. To achieve successful biopreservation, optimization of a multitude of pa- rameters, including cooling/thawing rates based on the biophysics of spe- cific cell types, the temperature of storage and transportation, as well as biopreservation media are of paramount importance. In particular, the choice of biopreservation media is pivotal for clearing regulatory hurdles and facilitating commercialization. Traditional extracellular-like (isoton- ic), home-brew cocktails (which may contain serum) may not be compat- ible with a Good Manufacturing Practices (GMP) clinical manufacturing process. This article will address the challenges associated with main- taining the viable recovery and functionality of ‘living drugs’, discuss the benefits and consequences of low-temperature biopreservation, outline Biopreservation Best Practices, and propose considerations for incorpo- rating Biopreservation Best Practices into a GMP cell therapy product. Integration of Biopreservation Best Practices, beginning with the selec- tion of optimized media, ensures that cells remain viable and functional throughout the cell product lifecycle, thereby optimizing manufacturing and clinical outcomes. Submitted for Review: 10 Apr 2017 u Published: 5 Jun 2017 www.insights.bio 345 CELL & GENE THERAPY INSIGHTS Average global life expectancy has this spotlight issue. Rafiq and Coop- accelerated by 5 years at the fast- man describe considerations of bio- est growth rate since 1950 between preservation that emerge with man- 2000 and 2015, and now exceeds ufacturing scale-up. Stacey speaks 71 years [1]. However, with this in- to standards and quality attributes crease in lifespan comes a growing for cryopreservation of stem cells, incidence of chronic human diseas- which are more difficult to define es prevalent in aging, such as can- than in normothermic cell models cer, cardiovascular and neurodegen- and have proven variable and more erative diseases. As such, sustained complex within biopreservation progress in extending life expectan- cell models. Fuller provides cryo- cy and quality of life requires the biology principles to allow further continued development of novel understanding into the complex therapies and approaches that ad- biophysical considerations at low dress chronic human conditions temperatures. This collection of ex- prevalent in an aging population. pert perspectives regarding biopres- A promising development in the ervation, and related considerations treatment of chronic diseases is the to the scientific background, Good use of living cells as ‘smart drugs’ Manufacturing Practices (GMP), that can effectively target specific Quality/Regulatory attributes, and tissues to rescue organ function or translation to clinical applications, eradicate tumors. In the case of can- is a unique and valuable resource for cer, cell therapies have proven effec- clinical and commercial developers tive in patients who have exhausted of cellular therapies and regenera- other lines of standard care treat- tive medicine applications. ment, with reported results includ- ing complete remission and exten- sion of median survival time [2,3]. As living drugs, cell therapies need THE CHALLENGE to be viable and functional in order OF CELL THERAPY to be effective, and methods for pre- COMMERCIALIZATION serving small molecules and mono- Cell therapies originate from bio- clonal antibodies are not similarly logical sources, such as tissue biop- effective for cell-based products. sies, blood and bone marrow. This Rather, they require cellular support biological seed material is then ma- during all phases of the product life- nipulated in a laboratory or manu- cycle, from source material acquisi- facturing facility to develop the cell tion to final delivery and patient ad- therapy product. Whether autol- ministration. Optimized strategies ogous or allogeneic, the develop- to maintain the viable recovery and ment and eventual introduction of efficacy of cell therapies during all the therapeutic dose into a patient stages of collection, manufacturing involves rounds of transportation and delivery are essential to realize between the collection site and the the potential of these promising laboratory or cell manufacturing medical advances (Figure 1). facility, as well as storage periods The critical focus of biopreserva- of varying durations for logistic tion, or product stability, is reflected arrangements and quality control in the broad topics and expertise that checks. Unlike pharmaceutical or are reported as perspectives within small molecule agents, cells and 346 DOI: 10.18609/cgti.2017.035 innovator INSIGHT f FIGURE 1 Biopreservation practices. Common traditional practice Manufactured cell/tissue product Collection Transport Processing Storage Transport Application Source material Biopreservation Preservation only considered for finished product Address yield issues AFTER negative system impact Recommended Best Practices Manufactured cell/tissue product Collection Transport Processing Storage Transport Application Source Material Relevant biopreservation continuum Biopreservation considered from source material to delivered product Do not wait until late clinical or commercial stages to optimize Common traditional biopreservation methods focus only on the finished product. Biopreservation Best Practices recommends optimizing biopreservation and reducing stability stresses from collection of source material through final cell/tissue product application. tissues have unique requirements critical step in the product lifecycle. in order to remain viable and func- In many cases, the sites of collection tional while outside the body or and processing may be physical- culture conditions. Therefore, an es- ly conjoined or in close proximity, sential component of the cell man- ensuring cellular products can be ufacturing lifecycle is to preserve transported and manipulated with cells during handling and storage. little impact to stability. As preclin- More so, improper preservation of ical product development progress- biologic specimens at any step in es, the process typically requires the the process may negatively impact need for more operators and re- all subsequent manufacturing steps, sources, and may require additional and may adversely impact the final collection or processing sites. Cell cell therapy product. handling and transportation to re- During the early developmental mote sites therefore becomes more phases of cell therapies, the storage complex with increased risk poten- and handling of cells is often not a tial. In a large-scale clinical trial, the Cell & Gene Therapy Insights - ISSN: 2059-7800 347 CELL & GENE THERAPY INSIGHTS collection and processing of hun- tissues remain outside of normo- dreds of patients may be spread be- thermic conditions. For commer- tween remote sites. At this stage, an cial cell therapy products, effective optimized means to store and trans- biopreservation protocols provide port cell-based products between flexibility in manufacturing and remote collection and manufactur- shipping, facilitate effective process ing sites becomes more critical for development, and reduce manu- minimizing variability, increasing facturing costs. An ideal biopres- clinical efficacy and ensuring com- ervation protocol would maintain mercial viability. biological function throughout the product lifecycle, providing ‘vein- to-vein’/‘needle-to-needle’ support from the time the sample is collect- LOW-TEMPERATURE ed from the donor to the time it is BIOPRESERVATION administered to the recipient. CONSIDERATIONS: Under normothermic condi- HYPOTHERMIC & tions, cells must continually gen- CRYOGENIC CONDITIONS erate energy in the form of ATP As soon as biological specimens to maintain the intracellular envi- are removed from the body and ronment and permit essential en- normothermic conditions, dele- zymatic reactions. Indeed, approx- terious environmental stresses be- imately 20% of energy production gin to degrade the source material. is used to drive selective ion pumps From a clinical efficacy standpoint, that maintain the intracellular ion- these environmental stresses are ic balance and resting membrane compounded at each step of the potential [6], a figure that can rise cell product lifecycle, introducing to approximately 66% in metabol- sample variability and the potential ically active neural tissue [7]. Cells for impaired therapeutic function, specifically regulate the transport which may even lead to clinical of sodium (Na+), potassium (K+) inefficacy and termination of a po- and calcium (Ca2+) ions across the tentially effective treatment. From plasma membrane, store additional a financial standpoint, loss of cell Ca2+ ions within the endoplasmic yield, viability and function adds reticulum, and effectively sequester significant cost to cell therapies by K+ within the cytoplasmic compart- increasing the potential for repeat ment. The energy required to main- sampling or additional processing tain these
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