Mfg News: Entos, Kite & FDA 

A roundup of manufacturing news from Entos Pharma, Kite Pharma and the US Food and Drug Administration. Highlights below. 

* Entos Pharma Opens Clinical-Scale Biomanufacturing Facility 
* Gilead’s Kite Pharma Gets FDA OK for New Mfg Process for CAR T Therapy  
* FDA Issues Final Guidance on CAR T Therapy Mfg 

Entos Pharma Opens Clinical-Scale Biomanufacturing Facility 
Entos Pharmaceuticals, a San Diego, California-based bio/pharmaceutical company, has launched a new GMP manufacturing facility in Carlsbad, California. This new site will allow Entos to support in-house production of drug substances for investigational new drug (IND)-enabling studies and clinical trials of the company’s pipeline of proprietary and partnered programs. 

The facility features 20,000 square feet of dedicated manufacturing space, including a lipid formulation production suite with additional suites dedicated to mRNA and plasmid DNA manufacturing. This facility is intended to support the clinical development of the company’s genetic medicine programs, including Covigenix, a COVID-19 booster vaccine, as well as future candidates in rare disease, eye and ophthalmic conditions, oncology, and other infectious diseases. The site would also support the manufacturing of clinical candidates for partnered programs for central nervous system disorders. 

Source: Entos Pharmaceuticals 

Gilead’s Kite Pharma Gets FDA OK for New Mfg Process for CAR T Therapy  
Kite Pharma, a Gilead Company, has announced that the US Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta (axicabtagene ciloleucel), a CAR-T therapy for treating lymphoma.   

With this approval, Kite’s median turnaround time (TAT) in the US is anticipated to be reduced from 16 days to 14 days. Median TAT is defined as the time from leukapheresis, when a patient’s T cells are collected, to product release; manufacturing is a key step within this process to prepare a patient’s cells for a one-time cell therapy infusion customized for each patient. 

Source: Kite Pharma 

FDA Issues Final Guidance on CAR T Therapy Mfg 
The US Food and Drug Administration (FDA) has issue final guidance for chimeric antigen receptor (CAR) T cell products, including recommendations for its non-clinical, clinical, and manufacturing expectations. 

Due to the complexity of CAR T products, the FDA acknowledged that the development, manufacture, testing, and clinical assessment could be challenging and noted some extra considerations. Due to the required biologic materials, manufacturing the products requires complex procedures that can cause variation between the different lots of products. In order to address the complex nature of CAR T products, the FDA urged companies to understand how changes to manufacturing can affect product quality. The agency additionally noted that critical process parameters (CPPs) can be utilized in order to create better consistency in products. 

The guidance is intended to assist sponsors, including industry and academic sponsors, developing ex vivo-manufactured CAR T cell products. In the guidance, FDA, provides CAR T cell-specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and design of clinical studies for oncology indications (including hematologic malignancies and solid tumors). Recommendations specific  to autologous or allogeneic CAR T cell products are noted in the guidance. The guidance also provides recommendations for analytical comparability studies for CAR T cell products.  

While the guidance specifically focuses on CAR T cell products, some of the information and recommendations provided may also be applicable to other genetically modified lymphocyte products, such as CAR Natural Killer (NK) cells or T cell receptor (TCR)-modified T cells. FDA says these related product types can be highly specialized, and in many cases, considerations beyond those recommended in the guidance would depend on the specific product and manufacturing process. 

Source: US Food and Drug Administration