Manufacturing roundup: AstraZeneca widens partnership in Abu Dhabi; Moderna finalizes its partnership with the UK
UK-based AstraZeneca and Abu Dhabi-based G42 Healthcare have inked a strategic manufacturing deal to make drugs in the capital of the United Arab Emirates.
The manufacturing deal will focus on R&D and “localizing” industries to produce pharma products, as AstraZeneca also has “ongoing efforts” with the Department of Health of Abu Dhabi.
Abu Dhabi has unveiled plans to double the size of its manufacturing sector by 2031, and this deal plays into that forecast, as both G42 and AstraZeneca collaborate to boost exports of drug products and collaborate on research projects.
“We are now taking our comprehensive existing partnership with G42 Healthcare to new heights, accelerating it across local manufacturing, research, innovation and sustainability,” said Sameh ElFangary, the cluster president for GCC and Pakistan at AstraZeneca, in a statement.
This is also not the first deal between the UK-based pharma and G42. The two kicked off with a “declaration of collaboration” in late 2021, and this past summer, G42 signed a letter of intent with AstraZeneca to expand collaboration in diagnostics and clinical research.
While the two parties are looking to increase manufacturing in Abu Dhabi, they’ve remained mum on the details of their deal, and they’ve given no indication of what is being produced or when manufacturing is set to begin. Endpoints News reached out to AstraZeneca for further comment but did not receive a response by press time.
Moderna makes headway with UK government deal
In the summer, Moderna looked to open a large-scale mRNA manufacturing center to produce Covid-19 vaccines and other vaccines for flu and RSV, and while the details on where the facility will be built are still not confirmed, the UK government and the vaccine maker have taken a step forward in making that center a reality, but no details on when or where it will be built have been revealed.
However, on Thursday, Moderna did announce the “finalization” of a strategic partnership with the UK government. Moderna CEO Stephane Bancel said in a statement that the new facility will plan to provide the UK with access to pandemic response capabilities with its Covid-19 vaccines and “future respiratory virus vaccine candidate” access.
Once the site, called the Moderna Innovation and Technology Center, comes online, it will plan to provide access to domestically-manufactured mRNA vaccines for respiratory viruses, pending regulatory action. Also, the MITC will support the UK in global efforts to reduce the impact of future pandemics.
Once operational, the Moderna Innovation and Technology Centre (MITC) is intended to provide access to a domestically manufactured portfolio of future mRNA vaccines against respiratory viruses, pending regulatory assessment and licensure. In addition, the facility is intended to provide the UK with direct access to pandemic response capabilities, which will support the UK in its global efforts as part of its “100 Days Mission” to reduce the impact of future pandemics. As part of the ten-year partnership, Moderna will also support the UK’s mRNA health and science ecosystem.
“When constructed, our facility will harness mRNA science with the aim of developing and manufacturing vaccines that have the potential to address future threats posed by respiratory viruses.” said Darius Hughes, general manager at Moderna for the UK, in a statement.
BioNTech’s manufacturing facility in Rwanda readies for kick-off
BioNTech’s efforts to have a manufacturing facility in Africa for mRNA are now taking a closer step to reality.
The six shipping containers, dubbed BioNTainers, for its manufacturing facility in the Rwandan capital of Kigali, have finished construction in Europe and have undergone quality checks by BioNTech. The company said that the containers are now being prepared for shipment to Kigali and are expected to arrive sometime in the first quarter of 2023.
Meanwhile, BioNTech is continuing the development and the build of the manufacturing facility itself in Kigali, which will house the BioNTainers, and will be a part of a decentralized manufacturing network in the African continent. BioNTech is planning to ship the containers to Senegal and potentially South Africa. The vaccines that are produced in BioNTech’s African network will be dedicated to patients living in African Union member states.
Investment firm KKR snaps up Japanese CDMO
The investment firm KKR has inked an agreement to acquire all the shares of the Japanese-based CDMO Bushu Pharma from BPEA EQT.
Bushu manufactures products such as oral medicines and injectables as well as clinical trial materials for the global market but has a focus on Japan and other nations in Asia, including China. KKR plans to work with Bushu’s management to expand its offerings in injectables as well as invest in “capacity expansion” and quality control.
The deal is expected to close in the first quarter of 2023.
“We see significant demand for strategic and reliable solutions to address a range of challenges facing the global healthcare industry. By leveraging KKR’s deep experience in healthcare, tech, and supply chain solutions, we aim to help Bushu Pharma to further scale its best-in-class business and to drive growth and technical innovation that will ultimately benefit patients in Japan and around the world,” said Hiro Hirano, the CEO of KKR Japan in a statement.
Alvotech handed a new date for FDA decision on Humira biosimilar
The Icelandic biosimilar producer Alvotech has been granted a new Biosimilar User Fee Amendment (BsUFA) goal date, set for April 13 of next year, for its original BLA for AVT02 as a biosimilar for Humira.
The approval of the application will require the “satisfactory” result of a reinspection of its facility in Reykjavik, Iceland. Alvotech said in its announcement it is working with the FDA to schedule the inspection for the first quarter of the new year. The key requirement for approval, according to Alvotech, is the same as for the original BLA, which is having a satisfactory outcome of the reinspection of the facility.
Meanwhile, in a statement, Alvotech Founder Robert Wessman is remaining confident about the anticipated launch of AVT02 in the US on July 1 of next year.
KBI nets a license from Swiss regulators for its expanded facility in Geneva
KBI Biopharma has been given a regulatory establishment license from Swissmedic, the nation’s authority for medicines, for its expanded mammalian cell manufacturing facility in Geneva.
The designation, according to KBI, shows that the expansion complies with cGMP standards. The thumbs up from the Swiss regulators also come after the facility was expanded in July of 2022. The expanded 8,733 square foot expansion includes a new manufacturing line for cells as well as accommodating its CDMO services.
“It’s critical for our drug development clients moving into phase one and phase two clinical trials to confidently partner with trusted cGMP-certified manufacturers for their growth and future success. This license is a critical component of KBI’s streamlined and cost-effective solutions to help worldwide biotechnology companies optimize their processes and advance their innovative therapies,” said KBI COO Mike Landau, in a statement.
Asymchem opens the doors to a new R&D facility in Massachusetts
The Chinese CDMO Asymchem has opened a new facility in the Boston suburb of Woburn, Massachusetts.
The new site will be centered on providing “early-stage” research and development services such as chemical process development, and the development of small molecules, peptides and oligonucleotides, among other services.
Asymchem’s new site has 6,000 square feet of lab space and can expand into an additional 4,500 square feet of space. Some labs will be online in the first quarter of 2023, but others won’t be ready until the third quarter.
“Asymchem has been working diligently in recent years to bring biotech clients an even more well-rounded CMC experience when managing early-stage projects. The company’s expansion to Boston has become an integral part of this journey to better serve Asymchem’s national and global partners.” Said Hao Hong, the CEO of Asymchem Group, in a statement.
Formulated Solutions acquires site in Tennessee for drug production
The Florida-based contract manufacturer Formulated Solutions has acquired a 43-year-old 455,000-square-foot site in Cleveland, TN, and is approved by the FDA.
The site, once the deal is completed, will manufacture nasal sprays, and, according to Formulated Solutions, the site has “extensive” production and packaging capabilities. The two-building site sits on 60 acres and has had several improvements over the years to be able to fulfill several manufacturing needs.
No details were given on the cost of the site or the headcount at the facility. The company currently has a 220,000-square-foot manufacturing site in central Florida.