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
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
At Akron, our Customer Relationship Management (CRM) system is more than just a database; it’s an adaptive framework that informs our developments and iterates based on our clients’ needs, just like our Quality Management System (QMS). The ideal CRM process focuses on the interactions between a business and its customers, with the principal goals of
Quality Assurance (QA) and Quality Control (QC) are two terms that are often used interchangeably. However, while some QA and QC activities are interrelated, the two are defined differently and encompass different activities. ISO 9000 defines Quality Assurance as “all the planned and systematic activities implemented within the quality system that can be demonstrated to
Aseptic processing is one of the most critical steps in the production of biopharmaceuticals. It is uniquely challenging in its requirements for personnel and facilities. Avoiding contamination requires careful planning, effective personnel training, attention to detail on the part of technicians, and specialized facilities and equipment. These activities, skills, and facility features are necessary to
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
Every year, the Medicine Maker, a global publication with a focus on the people that drive the development of small and large molecule drugs as well as advanced therapies, compiles a list of pioneers and influencers advancing the knowledge frontier, driving clinical application, and fostering industry growth. The annual Medicine Maker Power List is compiled
