An Eli Lilly aseptic facility in Indianapolis, which fills COVID-19 antibodies along with other drugs, has received a US FDA Form 483 with seven observations. The Form 483 (available below) was published last week and highlights the issues the US Food and Drug Administration (FDA) found after inspecting the facility in Indianapolis, Indiana in February and March this year. Among the seven observations noted, the Agency highlighted failures by Lilly to establish an adequate system for monitoring environmental conditions in…
Facilities & Capacity
Moderna inks deal to build mRNA facility in Canada
Moderna has signed a Memorandum of Understanding with the Canadian government to construct an mRNA vaccine manufacturing facility. The Memorandum of Understanding (MoU) will see Moderna build a messenger RNA (mRNA) vaccine plant, which aims to provide Canada with support to respond rapidly to current and future pandemics. While it is not yet confirmed where the plant will be located in Canada, the firm is looking to replicate this business model in other countries. “As a company, we are committed…
Rentschler doubling commercial capacity through US expansion
Driven by demand for an increasing complexity and diversity of modalities, CDMO Rentschler has broken ground on a second facility in Milford, Massachusetts. German contract development and manufacturing organization (CDMO) Rentschler laid down its US roots in 2019 when it bought a biomanufacturing facility from the now defunct Shire in January 2019 in Milford, Massachusetts – about 20 miles southwest of Boston. Now the firm has begun expanding its presence, breaking ground on facility adjacent to the ex-Shire plant set to…
Ginkgo and Aldevron partnership delivers tenfold mRNA improvement
The partnership with Aldevron has led to an mRNA breakthrough with their manufacturing approach proving 10 times more efficient than the previous process, says Ginkgo Bioworks. The collaboration, which was formed earlier in 2021, has resulted in what the firms have called a breakthrough for Vaccinia Capping Enzymes (VCEs) used to manufacture messenger RNA (mRNA) vaccines. VCEs cause the human body to recognize the RNA as something it can translate into a protein, which is essentially how the vaccine works.…
Artiva to build Californian NK cell therapy manufacturing facility
The facility in San Diego will support off-the-shelf NK and CAR-NK therapeutic manufacturing to treat solid and haematological cancers, the firm says. Construction of the 52,000 square-foot facility is already underway and is expected to open in 2022. The plant adds to Artiva’s cell therapy manufacturing site in South Korea. COO of Artiva Peter Flynn told BioProcess Insider that the site in Korea will continue its operations and the San Diego facility “is an additional site, it is not a…
BeiGene sets sights on US with NJ manufacturing facility
BeiGene plans to build an R&D and biomanufacturing facility at a 42-acre site in Hopewell, New Jersey. The deal, of which financial details have not been disclosed, sees BeiGene enter into a purchase agreement to acquire a site at the Princeton West Innovation Campus where it will construct a commercial-stage biologic manufacturing and clinical R&D facility. Hopewell’s central location and closeness to a pharmaceutical research, development, and manufacturing talent pool were cited by the firm as reasons to expand its…
Amgen forks out $550m to build drug substance facility in NC
The facility in Holly Springs, North Carolina will support stainless steel-fed batch manufacturing and single-use technologies making the plant more flexible, the firm says. The $550 million investment comes one week after Amgen announced plans to construct a $365 million plant in New Albany, Ohio to support drug packaging. “We are building the facility to support the growing demand for Amgen medicines in the US market,†an Amgen spokesperson told BioProcess Insider. “This new ‘FleXBatch’ drug substance plant will increase…
Ring raises $117m to fund development of anellovectors
“Virome†focused gene therapy vector firm Ring Therapeutics has raised $117 million in a funding round, attracting backing from venture capital funds and existing investors. The Cambridge, Massachusetts biotech announced completion of the series B fundraising round in July, explaining it will use the proceeds to further develop its range of vectors that are based on anelloviruses. CEO Tuyen Ong said. “With this funding, and the partnership of an exceptional group of investors joining us on this exciting journey, we…
BioNTech to develop mRNA-based malaria vaccine
BioNTech aims to develop the first vaccine for malaria using the same mRNA technology behind its COVID-19 success. BioNTech’s BNT162b2 became the first messenger RNA (mRNA) COVID-19 vaccine to receive emergency use approval in December 2020. Now the German firm has launched its Malaria project, which aims to produce a successful malaria vaccine and create sustainable production and supply in Africa. According to the firm, it will evaluate various vaccine candidates that feature known malaria trargets such as the circumsporozoite protein…
Bayview’s back: FDA gives Emergent green light to resume vaccine production
Emergent took a $54 million hit from remediation efforts and inventory write-downs at its Bayview plant and saw a $108 million reduction in its CDMO backlog. But now the firm is free to restart vaccine production for customer J&J. Emergent BioSolution’s Bayview, Maryland facility had been contracted by both Johnson & Johnson and AstraZeneca to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the plant with a Form 483 and a directive…