The challenge of raw material variability and strategies for standardization

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

Driving Innovation & Lowering Cost of Goods through Improved Customer Management

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

Aseptic processing to maintain the integrity of ancillary materials for cell therapy manufacturing

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

DMSO induces drastic changes in human cellular processes and epigenetic landscape in vitro

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 Joins Leading Companies and Research Institutions at the ARMI | BioFabUSA Spring Summit to Accelerate Innovation in Tissue Engineering

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-Derived Plasma Ancillary Materials for Cell Therapies: What Virus Inactivation Methods Should You Consider?

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

Dr. Zylberberg is Recognized as a Leader in the Cell and Gene Therapy Industry

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

The Importance of Standards and Manufacturing Needs – Recent Meetings

On Monday, March 18, the Standards Coordinating Body convened for a workshop on standards. The group discussed how standards are critical for the transfer of novel technologies from academia to clinical use. The FDA’s Judy Arcidiacono, one of the keynote speakers, discussed how standards are imperative to building the foundation of regenerative medicine innovation. The