Today, it is more important than ever to understand the quality of ancillary materials in the cell and gene therapy supply chain. As part of a therapy developer’s risk and impact assessment, each material must be evaluated for purity, lot-to-lot consistency, and potential impact on the drug product. Because of its outsized impact on cost
In the burgeoning cell and gene therapy market, companies at all stages of pre-clinical and clinical development are faced with a similar set of challenges of producing effective, standardized, and compliant therapies. The novelty of these technologies combined with the rigorous quality controls surrounding the materials and production process require a specialized approach for starting
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
The field of regenerative medicine is rapidly expanding due to the regulatory approval of breakthrough cell and gene therapy treatments. It is imperative now more than ever to keep patient safety in mind. For this reason, the industry has been shifting towards the use of animal-derived component free (ADCF) materials. Ancillary materials (AMs) are utilized
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
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
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
We as a community have long used the term “current good manufacturing practices,” or cGMP, to describe a class of ancillary materials – or raw materials in certain geographies – produced in accordance with rigorous quality standards. We have done this to assure our clients, often the developers of advanced therapeutic medicinal products (ATMPs), that
Akron’s sterile manufacturing facility, presented here before, enables the unique preparation of products within a fully aseptic manufacturing environment, including sterile filtration and container-closure filling. And while this allows Akron to manufacture cGMP-compliant, sterile-filled cytokines and ancillary materials for cell therapy, Akron also extends these capabilities as services to serve the industry: Owing to our unique facilities, our manufacturing capabilities are among
