A roundup of manufacturing news from Bristol Myers Squibb, Pfizer and Telix. Highlights below. 

* FDA OKs New Cell-Therapy Mfg Facility at BMS’ Site in Devens, Massachusetts 
* Pfizer Advises FDA of Potential Shortage of Two Penicillin-Based Drugs  
* Telix Opens Radiopharmaceutical Mfg Facility

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FDA OKs New Cell-Therapy Mfg Facility at BMS’ Site in Devens, Massachusetts 
The US Food and Drug Administration (FDA) has approved commercial production at Bristol Myers Squibb’s (BMS) new 244,000-square-foot cell-therapy manufacturing facility at its site in Devens, Massachusetts.  

BMS also operates two R&D facilities in Cambridge, Massachusetts and will bring these two sites together into a new building at Cambridge Crossing later in 2023. 

Devens adds to the company’s network of three cell-therapy manufacturing facilities in the following locations: Bothell, Washington; Warren, New Jersey; and Summit, New Jersey.  Another manufacturing site is in development in Leiden, the Netherlands. BMS also recently announced (April 2023) the addition of a new manufacturing facility and its operations for in-house viral vector production in Libertyville, Illinois. 

Source: Bristol Myers Squibb 

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Pfizer Advises FDA of Potential Shortage of Two Penicillin-Based Drugs   
Pfizer has advised the US Food and Drug Administration (FDA) of a potential shortage for two penicillin-based drugs: Bicillin L-A (penicillin G benzathine injectable suspension) and Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension) in prefilled syringes.  

Pfizer reported that the supply interruption is the result of increases in demand due to an increase in syphilis infection rates as well as competitive shortages. Pfizer said that it is prioritizing production of Bicilin L-A to avoid the shortage. 

Source: Pfizer 

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Telix Opens Radiopharmaceutical Mfg Facility 
Telix, a Melbourne, Australia-based bio/pharmaceutical company, has opened a new radiopharmaceutical production facility in Seneffe, Wallonia, Belgium. 

The 2,800-square-meter facility will serve as the company’s primary manufacturing site for radioisotopes and commercial and clinical products for the Europe, Middle East, and Africa (EMEA) region.

The first stage of the build-out, which is complete, included the installation of nine GMP manufacturing lines, two research and development laboratories, quality control labs, and warehousing space. One of the first GMP lines will be dedicated for third-party use and partners. The company is also preparing to install the first of two planned cyclotrons for the site.   

Source: Telix