• Smith JA, Ng KS, Mead BE, Dopson S, Reeve B, Edwards J, Wood MJA, Carr AJ, Bure K, Karp JM, Brindley DA. Extracellular Vesicles: Commercial Potential As Byproducts of Cell Manufacturing for Research and Therapeutic Use. BioProcess International. 13(4). Read on external site. Categories: Delivery Mechanisms

    Extracellular Vesicles: Commercial Potential As Byproducts of Cell Manufacturing for Research and Therapeutic Use.

    BioProcess International. 13(4).

    Extracellular Vesicles: Commercial Potential As Byproducts of Cell Manufacturing for Research and Therapeutic Use.

    Smith JA, Ng KS, Mead BE, Dopson S, Reeve B, Edwards J, Wood MJA, Carr AJ, Bure K, Karp JM, Brindley DA.

    Abstract

    Abstract:

    Extracellular vesicles (EVs) are emerging as a potential alternative to some stem-cell–derived therapeutics. Sometimes called exosomes, they are small, secreted vesicles that can possess similar therapeutic mechanisms to whole cells, possibly representing the active pharmaceutical ingredient. In the past 15 years, academic and industry interest in EVs has exponentially increased as mounting evidence demonstrates their role in physiology and pathology as well as their therapeutic potential.

    In light of growing efforts in using EVs for research and therapy, optimizing EV manufacturing is important. However, many challenges come with their characterization, scalable manufacture, and regulatory status. Here, we briefly review the biology and therapeutic application of EVs, discuss associated challenges, and suggest how the biotechnology industry could play an important role in overcoming those challenges. Many cell manufacturing companies currently produce EVs but discard them as waste, thereby losing a potentially valuable resource with multiple purposes in a market that’s otherwise rich with an exorbitant cost of goods.

  • Brindley DA, French AL, Baptista R, Timmins N, Adams T, Wall I, Bure K. Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence. BioProcess International 12(3)s (March 2014). Read on external site. Categories: Beyond the Bench, Delivery Mechanisms

    Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence.

    BioProcess International 12(3)s (March 2014).

    Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence.

    Brindley DA, French AL, Baptista R, Timmins N, Adams T, Wall I, Bure K.

    Abstract

    Abstract:

    The cell therapy industry is undergoing a natural evolution from scientific curiosity into a commercially and clinically attractive opportunity (1). This evolution is by no means complete, and growing evidence suggests that its progression is driving significant developments in cell therapy bioprocessing — notably, convergence.

  • Culme-Seymour EJ, Davie NL, Brindley DA, Edwards-Parton S, Mason C. A decade of cell therapy clinical trials (2000–2010). Regen Med. 2012 Jul;7(4):455-62. PubMed: 22817619. Categories: Delivery Mechanisms

    A decade of cell therapy clinical trials (2000–2010).

    Regen Med. 2012 Jul;7(4):455-62.

    A decade of cell therapy clinical trials (2000–2010).

    Culme-Seymour EJ, Davie NL, Brindley DA, Edwards-Parton S, Mason C.

    Abstract

    Abstract:

    The cell therapy industry (CTI) is presently a small but potentially rapidly growing new global healthcare sector. Success is totally dependent on resolving a number of factors unique to cells as therapies, including: manufacturing, enabling technologies, regulation, reimbursement and essential infrastructure. To understand how to solve these challenges in a timely and cost-effective manner, it is essential to be able to forecast the size and resource demands of the sector for a least the next decade. Due to the highly regulated nature of medicines, one predictive method is to analyze the candidate therapies that are currently undergoing clinical trials (i.e., the future pipeline). A search was performed on the website ClinicalTrials.gov using the embedded search engine and key terms relating to ‘cell therapy’. A total of 17,362 files were extracted (27 June 2010) and individually checked for relevance using the British Standard Institute (BSI) definition of ‘cell therapy’. The resulting 2724 trials were then categorized and core information collated, including: trial phase, cell source (autologous/allogeneic), current activity of the trial and responsible national regulatory agency. Key results included: near equal numbers of autologous (46%) and allogeneic (41%) trials; many of the trials are in the later stages – Phase I (49%), Phase II (40%) or Phase III (10%); and there are significantly larger numbers of transient cell therapies (50%) as opposed to permanent cell replacement (5%). This is the first time that the number and composition of all the cell therapy trials on ClinicalTrials.gov has been researched at the level of individual entries, analyzed and published. These data have important planning and resource allocation implications for translational scientists, clinicians, healthcare providers, businesses and governments.