A roundup of manufacturing news from Novartis, BeiGene, Bavarian Nordic, Pfizer, Deka Biosciences, Hemogenyx Pharmaceuticals, and TFF Pharmaceuticals. Highlights below.

* FDA Defers Decision on Novartis’, BeiGene’s Cancer Drug Due to Inspection Delay
* Bavarian Nordic To Supply More Doses of Monkeypox Vaccine
* Pfizer Recalls One Lot of Anesthetic Drug Propofol
* Deka Biosciences Breaks Ground on Process R&D, Mfg Facility
* Hemogenyx Pharmaceuticals Opens R&D Mfg Facility
* TFF Pharmaceuticals Leases New Process R&D Facility

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FDA Defers Decision on Novartis’, BeiGene’s Cancer Drug Due to Inspection Delay
The US Food and Drug Administration (FDA) has deferred action on the biologics license application for tislelizumab, an esophageal cancer drug from Novartis and BeiGene, due to a delay in inspections related to COVID-19-travel restrictions.

The FDA has been unable to conduct required inspections in China due to COVID-19-related travel restrictions. As a result, the FDA is deferring action on the application until the inspections are complete. The FDA cited only travel restrictions and the inability to complete inspections as the reason for the deferral. The application remains under review, and the FDA did not provide a new anticipated action date.

In September 2021, the FDA accepted the BLA for tislelizumab as a second-line treatment for patients with unresectable or metastatic esophageal squamous cell carcinoma and provided a Prescription Drug User Fee Act goal date of July 12, 2022.

Novartis has the rights to develop, manufacture, and commercialize tislelizumab in North America, Europe and Japan through a collaboration and license agreement with BeiGene. The  companies formed a $2.2-billion licensing agreement for the drug in January 2021 under which BeiGene received $650 million upfront and is eligible to receive up to $1.55 billion in milestone payments for tislelizumab in major markets outside of China.

Source: BeiGene

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Bavarian Nordic To Supply More Doses of Monkeypox Vaccine
Bavarian Nordic has entered into agreements to supply an additional 2.5 million doses of its monkeypox vaccine to the US government and an additional 1.5 million doses of the vaccine to an undisclosed European country. The company’s monkeypox vaccine is a non-replicating smallpox vaccine marketed under the name Jynneos in the US and Imvanex outside the US.

The new order with the US Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, follows two previous orders with BARDA in June and July 2022 for 500,000 and 2.5 million doses, respectively, which, together with the an initial order with BARDA in 2020 for 1.4 million doses, will bring the total deliveries to the US government in 2022 and 2023 to nearly 7 million doses.

The new additional order will be filled at a US-based contract manufacturer using bulk vaccine already manufactured and invoiced under previous contracts with BARDA and currently stored at Bavarian Nordic. A tech transfer of the process to the contract manufacturer will begin immediately (as reported on July 15, 2022), with the aim to manufacture all doses under this contract in 2022.

While the bulk vaccine has already been invoiced, the final drug production of the vaccines (formulation, filling and freeze-drying) will occur from 2023 and onwards. In May 2022, BARDA exercised the first contract options for conversion of the bulk vaccine to freeze-dried doses, anticipated for delivery in 2023–2025. In light of the current global monkeypox outbreak, BARDA has also exercised options for manufacturing of the liquid-frozen formulation of the vaccine for delivery in 2022 and 2023.

In a separate agreement, Bavarian Nordic agreed to supply an additional 1.5 million doses of the vaccine to an undisclosed European country. While deliveries under this contract will start in 2022, the majority of the doses will be delivered during 2023. 

The vaccine is approved for use against monkeypox by the US Food and Drug Administration and Health Canada. It was initially approved for immunization against smallpox by the European Commission in adults aged 18 years and older and subsequently gained regulatory approvals in Canada and the US, where the approval has been extended to include the monkeypox indication.

Source: Bavarian Nordic (US agreement) and Bavarian Nordic (EU agreement)

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Pfizer Recalls One Lot of Anesthetic Drug Propofol
Hospira, a Pfizer company, is voluntarily recalling one lot of propofol injectable emulsion, USP (containing benzyl alcohol), 100-mL single-patient use glass fliptop vial, to the user level due to a visible particulate observed in a single vial during annual examination of retain samples.

The product lot was distributed nationwide in the US to wholesalers, hospitals, and the US Department of Defense from June 10, 2020 through June 26, 2020.

To date (as of July 13, 2022), Pfizer’s Hospira reports that it has not received reports of any adverse events associated with this issue for this lot.

Propofol is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia or sedation.

Source: Pfizer

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Deka Biosciences Breaks Ground on Process R&D, Mfg Facility
Deka Biosciences, a Germantown, Maryland-based bio/pharmaceutical company focused on cytokine therapies, is breaking ground on a 14,000-square-foot office and lab that will house a research and development, process development, and manufacturing facility for cytokine therapies. The facility will house the company’s new headquarters in Germantown, Maryland, and Deka anticipates the move to be completed in the first quarter of 2023.

Source: Deka Biosciences

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Hemogenyx Pharmaceuticals Opens R&D, Mfg Facility
Hemogenyx Pharmaceuticals, a London-based preclinical bio/pharmaceutical company, has opened a 10,000-square foot-laboratory and research facility in West Harlem’s Manhattanville Factory District of New York City. The space includes two cleanrooms for cell-therapy manufacturing to provide the company the ability to manufacture cells in-house, including its Hemo-CAR T therapy for treating acute myeloid leukemia. The company moved from its site in Brooklyn to the West Harlem location.

Source: Hemogenyx Pharmaceuticals

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TFF Pharmaceuticals Leases New Process R&D Facility
TFF Pharmaceuticals, an Austin, Texas-based clinical-stage bio/pharmaceutical company, has expanded its R&D operations through the lease of a new R&D facility in Austin. The new facility has over 3,500 square feet of lab space, which includes a dedicated lab for downstream processing using the company’s thin-film freezing technology, a particle-engineering process for generating dry-powder particles for inhalation, parenteral, nasal, oral, topical and ocular routes of administration.

Source: TFF Pharmaceuticals