FDA clears the way for more monkeypox vaccines to be released; Discovery Life Science net acquisition – Endpoints News

While the monkeypox virus continues to rage across the country, more vaccines are making their way to the US.

According to a report from the AP, Thousands more doses of the monkeypox and smallpox vaccine Jynneos, manufactured by Bavarian Nordic, are expected to soon be shipped to the US after the FDA said they had completed an inspection of a Denmark-based manufacturing plant.

More than 1.1 million doses of the vaccine purchased by the US government are currently sitting in Bavarian Nordic’s facility. The company previously said that it needed authorization from an on-site FDA inspection before it could be shipped stateside.

So far, Bavarian Nordic has shipped 300,000 vaccine doses that were made at a third-party facility that had previously been authorized by the FDA. The US regulator typically requires inspections of all vaccine plants to ensure there are no safety or sterility issues, prior to a vaccine exception to hit the market, although the Pfizer and Moderna Covid-19s were notables as the agency conducted no new vaccine inspections prior to their authorizations.

Bavarian Nordic’s Jynneos has been well touted by several governments since the monkeypox outbreak and the company has secured several contracts including a contract with Canada worth $56 million as well as with Germany and several other European nations.

Discovery Life Science acquires cell provider

Alabama-based Discovery Life Science has netted the acquisition of California-based research cell provider AllCells.

AllCells, a provider of clinical-grade and ROU primary cell products, has more than 30 years of collective cell and gene therapy experience, AllCells and Discovery will focus on providing products and services for customers in the cell and gene therapy space including basic discovery and commercialization.

“We are very excited to welcome the AllCells team to the Discovery family. Bringing these two great companies together creates a scalable, end-to-end solution that gives our clients access to reliable human cellular starting materials with integrated multi-omic analytic services to support cell and gene therapies,” said Discovery CEO Glenn Bilawsky in a statement.

According to Discovery, they will combine its existing CGT products and services with AllCells to create a new business unit dubbed AllCells, a Discovery Life Sciences Company. AllCells CEO and president Danny Zheng will lead the combined entity.

In an email to Endpoints News, Discovery said the next step for the new entity is “business as usual”.

“The difference now is the availability of the combination of Discovery and AllCells’ unified offerings under a single brand; Creating a unique vendor capable of speed, scale, and flexibility that was previously unavailable to accelerate cell and gene therapy programs,” the statement said.

This marks another acquisition for Discovery as, in 2021, acquired Albert Li’s project. Li, who founded the hepatocyte inventory company IVAL in 2004, joined the Discovery leadership team as the CSO of pharmacology and toxicology.

Spanish-based Agarose Bead Technologies plans to increase manufacturing capacity

Spanish life science player Agarose Bead Technologies (ABT) is planning a major expansion of its manufacturing capabilities.

According to a report from Manufacturing Chemist, The company is tripling its production capacity to meet the demand for agarose resins and plans to increase its space by 1000 square metres.

The company is aiming to manufacture and deliver a continuous supply of agarose resins to eventually support novel therapies worldwide including the mRNA-based COVID-19 vaccines. However, the cost and exact size were not disclosed.

ABT will also seek to expand its three independent warehouses located in the United States and Spain as well. The project is set to come online in 2023.

Industrial company to make a wider expansion into API production in Michigan

WR Grace & Co., a specialty silica and chemicals producer, today announced it is proceeding with an expansion of its contract development and manufacturing (CDMO) facility in South Haven, MI.

The expansion will bring a new 4,000-gallon multi-use reactor train and a new centrifuge to facilitate product isolation, which aims to enhance its commercial capabilities.

The project will bring their South Haven facility up to three reactor trains enabling its manufacturing services business to support the continued growth of small molecule drug production including custom APIs, cGMP intermediates, and generic APIs. The expansion is estimated to be completed in January 2024. The cost and size of the expansion were not disclosed.

The facility was acquired by Grace in June last year by Albemarle to expand its pharmaceutical portfolio.

“Our South Haven expansion demonstrates this commitment and addresses the increased market demand in small molecule drug substance manufacturing that has taken place year over year in the past decade. Anticipating the needs of the market, coupled with our expertise, are key Grace capabilities that work together to enable customer success,” said Grace CEO Bob Patel in a statement.

ProBioGen nets deal for manufacturing services for Swiss Biotech

Granite Bio, biotech built through Versant Venture’s discovery engine Ridgeline Discovery, and ProBioGen have closed on an agreement to support the development of Granite Bio’s mAb pipeline.

The Swiss biotech’s lead candidate is a novel monoclonal antibody for the treatment of autoimmune and certain cancer indications. The deal will see ProBioGen start cell line development with multiple candidates, from which one selected candidate will finally be further manufactured.

“In addition to ProBioGen’s proven expertise in cell line and CMC development, it was their proprietary technologies and flexibility that enabled a tailored start of the project and convinced us to select ProBioGen as a partner for our lead candidate,” said Alexander Mayweg, chairman of the board of Granite Bio in a statement.

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