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 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 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
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
