A roundup of manufacturing news from BioNTech, Pfizer’s Hospira, and Sagent Pharmaceuticals. Highlights below. 

* BioNTech, CEPI Advance mRNA Vaccine Mfg in Africa
* Pfizer’s Hospira Recalls Select Lots of Injectables for Packaging Issue 
* Sagent Recalls Select Lots of Cancer Drug Docetaxel for Particulate Matter 

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BioNTech, CEPI Advance mRNA Vaccine Mfg in Africa 
BioNTech, a Mainz, Germany-based bio/pharmaceutical company, and the Coalition for Epidemic Preparedness Innovations (CEPI), a public–private coalition that develops vaccines against infectious diseases, are expanding their strategic partnership to build an end-to-end vaccine ecosystem in Africa, including manufacturing.    

CEPI is committing up to $145 million to support BioNTech to establish mRNA vaccine R&D, clinical, and commercial-scale manufacturing capabilities at the company’s facility in Kigali, Rwanda. These capabilities will contribute to efforts to better prepare for potential future epidemic and pandemic threats in Africa. 

The BioNTech-CEPI partnership aims to back the company’s existing efforts in three key areas for Africa’s pandemic preparedness and vaccine ecosystem: (1) commercial-scale manufacturing; (2) end-to-end clinical-scale manufacturing of vaccine candidates; and (3) strengthening the African R&D ecosystem for mRNA-based vaccines. 

Under the agreement, BioNTech intends to provide affordable access to BioNTech’s prophylactic vaccines manufactured at the Kigali facility, such as vaccines against malaria, mpox and tuberculosis, to low and middle-income countries, with priority supply to African countries, if successfully developed and authorized. BioNTech and CEPI intend to work jointly to rapidly respond to outbreaks on the African continent caused by known viral threats, or an as-yet-unknown pathogen with epidemic or pandemic potential. 

Source: BioNTech 

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Pfizer’s Hospira Recalls Select Lots of Injectables for Packaging Issue 
Hospira, a Pfizer company, is voluntarily recalling select lots of buprenorphine hydrochloride injection Carpuject units and labetalol hydrochloride injection, USP Carpuject units to the user level in the US. The recall was initiated due to the potential for incomplete crimp seals; one customer complaint has been received for one leaking unit. 

Buprenorphine HCl injection is indicated for the management of pain requiring an opioid analgesic and for which alternate treatments are inadequate. Labetalol HCl injection is indicated for control of blood pressure in severe hypertension. 

To date (as of May 21, 2024), Pfizer says it has not received reports of any relevant adverse events associated with this issue for these lots. 

Source: US Food and Drug Administration 

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Sagent Recalls Select Lots of Cancer Drug Docetaxel for Particulate Matter 
Sagent Pharmaceuticals, a Buffalo Grove, Illinois-based bio/pharmaceutical company, has announced the voluntary nationwide recall of two lots of the cancer drug, docetaxel injection, USP (80 mg per 8-mL multi-dose vials and 160 mg per 16-mL multi-dose vials) to the user level in the US.  

Sagent initiated the recall as the result of a customer complaint due to the potential presence of particulate matter from the stopper in the drug product. 

To date (as of May 28, 2024), Sagent Pharmaceuticals says it has not received any reports of adverse events related to this recall. 

Source: US Food and Drug Administration