Ancillary materials play a critical role in the manufacture of cell and gene therapies, and best practices for their quality management are the subject of ongoing discussion. Given that these therapies cannot be sterilized, ancillary material quality is critical to clinical advancement and commercialization. At Akron, we believe that a harmonized definition of what constitutes
Clinical trials occur in phases – Phase I through Phase III – and if successful, culminate in FDA approval to market a drug product. In the US, Phase III trials generally assess if a new treatment method or drug product is as effective or better than existing treatments or products. In short, Phase III trials
The field of immunometabolism has attracted growing attention in recent years due to the high potential for the development of cancer immunotherapies. Upon activation, T lymphocytes (T cells) undergo significant metabolic changes that allow them to mediate immune responses. Stimulating these and other immune cells has important outcomes beyond energy production (Fig. 1). A key
Akron recently participated in the Alliance for Regenerative Medicine (ARM) Cell & Gene Meeting on the Mesa, joining hundreds of the largest companies in the cell and gene therapy space to discuss progress to date and foster a shared vision for the future of regenerative medicine. Panels covered themes including the impact of Brexit on
The advancement of cell therapies depends on the success of industry-wide efforts to reduce variability in source materials, manufacturing processes, and analytical strategies. A newly-published paper in Regenerative Engineering and Translational Medicine identifies several sources of variability throughout the cell therapy supply chain, manufacturing process, and release testing, and identifies standardization efforts, automation strategies, and
As Autumn quickly approaches and conference season begins, the Akron Biotech team is preparing to participate in several events showcasing talks by leading industry experts and exhibitions spanning the cell, gene and biotech therapeutic industries. These events offer a great opportunity for Akron to better understand our clients’ challenges, global regulatory directives and how our
Dimethyl sulfoxide (DMSO) is an organic solvent that is widely used as cryoprotectant for freezing cells and tissues. Clinically, DMSO is considered a potent anti-inflammatory, nerve blocker (analgesic), diuretic, vasodilator and muscle relaxer. In cells, DMSO is used to induce differentiation, as a free radical scavenger, and most notably, to prevent ice formation during cryopreservation.
Akron Biotech recently participated in the ARMI | BioFabUSA Spring Summit in Manchester, NH, joining several leading research institutions and companies to continue charting a path forward for the tissue engineering industry. If we think about innovation as a process of bringing old ideas together to make new things, then ARMI is uniquely suited to
Human plasma is defined as “clear, straw colored, complex liquid that is 7% protein, 91% water, and 0.9% mineral salts” and can be derived from Source or Recovered Plasma. Today, human plasma is used to produce several ancillary materials such as Human AB Serum, Human Fibronectin, Human Serum Albumin (HSA), and Human Vitronectin. These materials
Many cancer therapies that have emerged in the past decade have been developed to increase anti-tumor immunity. Specifically, these therapies promote innate and adaptive immune responses and equip the body’s own immune system to work as a weapon against tumors. Currently, most approaches have focused on enhancing T cell responses. One such approach targets inhibitory
