Mfg News: GSK, Pfizer, BioNTech, Novartis & Lupin

A roundup of manufacturing news from GlaxoSmithKline, Pfizer, BioNTech, Novartis, and Lupin. Highlights below.

* GSK Opens $33-M High-Potency Mfg Facility
* Pfizer To Divest Sterile Injectable Mfg Facility to Bridgewest Group
* BioNTech To Acquire Novartis’ Mfg Facility in Asia
* FDA Cites Lupin’s Injectable Mfg Facility

GSK Opens $33-M High-Potency Mfg Facility
GlaxoSmithKline has opened a S$44 million (US$33 million) high-potency manufacturing facility at its site in Jurong, Singapore. The facility will be used to produce a cytotoxic component in antibody drug conjugates (ADCs) for treating cancer. The Jurong site serves as a new product introduction site for GSK.

Source: GlaxoSmithKline

Pfizer To Divest Sterile Injectable Mfg Facility to Bridgewest Group
Pfizer has agreed to divest its sterile injectables manufacturing facility in Bentley, Australia, to Bridgewest Group, an investment firm.

The cGMP manufacturing facility has blow–fill–seal (BFS) capabilities for producing sterile injectable drug products and specialty oncology drug products for global distribution. In addition to the operations and facility, Bridgewest Group will also be acquiring a suite of drug products from Pfizer.

Source: Bridgewest Group

BioNTech To Acquire Novartis’ Mfg Facility in Asia
BioNTech, a Mainz, Germany-based bio/pharmaceutical company, has agreed to acquire a manufacturing facility in Singapore from Novartis and plans to convert the facility into an mRNA manufacturing facility. The acquisition is part of BioNTech’s expansion strategy to strengthen its global footprint in Asia, and the facility will serve as BioNTech’s regional headquarters in Asia.

The site will be a fully integrated mRNA manufacturing facility for both drug-substance and drug-product manufacturing with an expected annual production capacity of up to several hundred million doses of mRNA-based vaccines after a full build-out. The new facility is expected to create more than 100 jobs by 2024 across multiple functions, including operations, engineering, quality, finance, human resources, and supply-chain management.

The new facility will provide regional manufacturing capacities in support of BioNTech’s pipeline of mRNA-based vaccines and therapeutics across the Asia Pacific region for both commercial and clinical scale, with the potential to expand the production to other drug classes, such as cell therapies. The facility will be initially equipped to manufacture a range of mRNA-based product candidates as well as authorized vaccines and therapeutics for infectious diseases. This may include the company’s COVID-19 vaccine, as well as oncology drug candidates.

Source: BioNTech

FDA Cites Lupin’s Injectable Mfg Facility
The US Food and Drug Administration has issued Lupin, a Mumbai, India-headquartered bio/pharmaceutical company, a Form 483 with five observations following a pre-approval inspection at the company’s injectables manufacturing facility in Nagpur, Maharashtra, India. The inspection took place in October 2022.

“We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US,” said the company in an October 30, 2022, notification letter to the Bombay Stock Exchange and National Stock Exchange of India.

In late September (September 2022), the FDA issued Lupin a Warning Letter for its active pharmaceutical ingredient facility in Boisar, Palghar, Maharashtra, India. Additionally, in late October (October 2022) the FDA issued Lupin a Form 483 for its biomanufacturing facility in Pune, India.

Source: Lupin