Monday, May 1, 2023 Daily Archives

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

The cell harvesting step is of utmost importance for cell therapy manufacturers. During this step, high cell viability and recovery are important to maximize yield. Single-use, low shear closed-system centrifuges enable safe and efficient cell therapy manufacturing through the efficient recovery of viable cells. Additionally, in the production of cellular-based therapies, media and buffer are often used to remove unwanted proteins, serums, and debris prior to the eventual administration to patients or for research and treatment purposes. Download this case…

Addressing the Gassing Rate in Bioreactor Upscaling – is vvm a Reliable Parameter?

Common approaches for the scale-up of bioreactors use the gas flow coefficient (vvm) as a criterion for volumetric flow rates. Besides being the most common decisive parameter when it comes to the scaling of the gassing rate, a defined vvm is frequently used in the context of process validation, and therefore considered essential for qualification. ZETA called the reliability of this parameter into question and evaluated the scaling competence of vvm in a study performed in the context of commissioning…

Aldevron ups mRNA capacity in North Dakota

Aldevron will add lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities in Fargo on the back of post-COVID demand for mRNA therapies and vaccines. The additional drug product services will enable contract development and manufacturing organization (CDMO) Aldevron to offer customers full messenger RNA (mRNA) services from the site in Fargo, North Dakota. According to Mark Wetzel, VP and general manager of mRNA Services at Aldevron, the long-planned expansion has been driven by high interest and increased demand following the modality’s…