Manufacturing roundup: AGC Biologics to manufacture diabetes therapy; Cambrex caps acquisition of Snapdragon Chemistry

26 Jan 2023
endpts.com
AcquisitionDrug ApprovalVaccine
The Washington-based CDMO AGC Biologics has been tapped to manufacture the type 1 diabetes treatment Tzield from Provention Bio. AGC Biologics will produce Tzield at its Seattle protein biologics site. It was chosen after AGC helped to guide the product through process performance qualification (PPQ) manufacturing and validation batches, and, ultimately, FDA approval. Tzield is the only immunomodulatory treatment approved to delay the onset of Stage 3, type 1 diabetes in children and adults aged eight and older. Details about the size of the contract or how many doses AGC will manufacture were not immediately available. The Seattle facility has multiple manufacturing lines and has been producing biologics for more than 30 years. “This achievement demonstrates our Seattle site’s increasing track record in commercial manufacturing, which is aligned with AGC Biologic’s purpose of bringing hope to life,” said Kevin Ingham, general manager of AGC Biologics’ Seattle site, in a press release . Cambrex closed its acquisition of the ingredient producer Snapdragon Chemistry, netting the latter’s two facilities in Waltham, MA, in the deal. Snapdragon Chemistry mainly manufactures active pharmaceutical ingredients, using automation technology and its proprietary equipment in the process. The deal also includes Snapdragon’s 70+ employees joining Cambrex. Cambrex said in a news release that it plans to use the new acquisition to grow its portfolio of “specialized solutions” for pharmaceutical manufacturing and bolster overall capabilities. The CDMO is also sinking more funds into active pharmaceutical ingredient (API) development in general, as it has finished the first part of a $30 million expansion at its API manufacturing facility in the city of High Point, NC. “With Snapdragon’s depth of scientific expertise in API process development, I’m certain our customers will see the benefits of this combination and be delighted to work with Snapdragon’s team,” said Cambrex’s CEO Tom Loewald in the release. Massachusetts-based EyePoint Pharmaceuticals is planning a brand-new facility to produce two of its products. Eyepoint will be involved in the custom design and construction of the 40,000-square-foot manufacturing facility in Northbridge, MA, to manufacture its intravitreal eye implant Yutiq along with a second implant, EYP-1901, in clinical studies. The facility, which will be built and managed by VE Properties IX, is expected to be operational in the second half of 2024. It will have 45 employees within the next five years and have enough room for any additional growth, an EyePoint spokesperson said in an email to Endpoints News . The lease terms were not disclosed. “This new facility provides us with significant manufacturing capacity to accelerate the clinical development and future commercial production for EYP-1901, as well as support global demand for our U.S. FDA and China NMPA-approved therapy, YUTIQ. This strategic investment in a commercial scale facility reflects our commitment to EYP-1901, YUTIQ and the focus on building a strong pipeline for long-term shareholder value,” said Eyepoint CEO Nancy Lurker in a press release . The Eyepoint spokesperson also pointed out that the facility will only manufacture those two products for now, and did not disclose the volume of production. UK CDMO Upperton Pharma Solutions kicked off construction of its new development and manufacturing headquarters in the city of Nottingham, UK. The 50,000-square-foot facility plans to be fully operational by the end of the year. Upperton announced last May that the facility will be a 10-fold increase from its current manufacturing space, along with 10 manufacturing suites, and will cost around £15 million ($18.6 million) and is expected to create 150 jobs by the end of 2024. The facility will be near its current headquarters and expand Upperton’s capacity and scale of production. “This plant has been in the planning for almost twelve months, so to see the plans finalized and work start on the site is hugely satisfying not only to us as a business but also for our customers as we can now offer them a seamless transition from early development to clinical trials and commercial manufacturing, all at the one site,” said Upperton CEO Nikki Whitfield, in a statement . Ohio-based Forge Biologics is bringing in three new VPs into its leadership team. First, Forge is bringing in Chris McPherson as vice president of GMP manufacturing. McPherson has 25 years of industry experience in commercial biologics manufacturing, tech transfer and other areas of expertise. Before Forge, McPherson worked for companies such as Guilford Pharmaceutical, Cambrex Bioscience, WuXi AppTec, Biotest Pharmaceutical and Samsung Biologics. Taleen Barsoumian will be vice president of client development at Forge, leading its client development strategy and “new business operations.” Barsoumian was previously the US director of sales and business development for Cell and Gene at the Barkey Corporation and has 18 years of experience in the business. Adam Davis now is the vice president of analytical development and leads the in-house analytical development and testing team. Davis joined Forge in 2020 after serving as the director of manufacturing at Abeona Therapeutics. He was also the manufacturing scientist at BioMarin Pharmaceuticals. “Expanding our leadership team with these strategic hires, and the caliber of experience each member brings, supports our vision for growth and the value we provide to our more than 30 partners as we continue to expand our leadership in gene therapy development and manufacturing,” said Forge CEO Timothy Miller, in a statement . The Japanese CDMO Kaneka will be increasing its presence at its facility in Liège, Belgium to boost mRNA manufacturing capabilities. Kaneka said in a press release that it plans to start operations sequentially from the end of 2023, as well as investing 2 billion yen, or around $15.4 million, and have five times the current production capacity at the site. The CDMO noted in its press release that while mRNA is currently being used in Covid-19 vaccines, it expects mRNA applications in other vaccines and products, and that demand will likely “increase dramatically.” “The demand for GMP manufacturing of mRNA will increase drastically with the active development of biopharmaceutical pipelines by pharmaceutical companies worldwide,” the company said in the release. Kaneka already manufactures plasmid DNA, recombinant proteins, oligonucleotides and other drug substances. It began manufacturing mRNA in 2020. New Jersey-based CDMO Experic is expanding its analytical laboratory and services. The new lab, based at Experic’s headquarters in Cranbury, NJ, covers 3,800 square feet and will support its wider manufacturing services as well as add more employees and equipment to the facility, the company said in a news release . “Analytical services are integral to every development project and drug substance we work with. By expanding our team and capabilities, we can respond to clients more quickly and more cost-effectively while providing a more complete end-to-end solution that clients want and need. With our business growing rapidly, it became imperative to expand the laboratory,” said Justin Lacombe, Experic’s CEO in the release. Beckman Coulter Life Sciences has put the finishing touches on the first phase of its new research and development hub in Loveland, CO. The $10 million complex will house the company’s R&D efforts as well as allow for 85 jobs to be created in the coming years, the company said in a press release emailed to Endpoints. The company currently has a headcount of 140 in Loveland. The new complex includes 56,000 square feet of office space and a new “customer engagement center.” The second phase of the project, which has just started, will include a 37,000-square-foot manufacturing operation that will be attached to the office. Groundbreaking on the second phase will begin by the second quarter of 2023, with the expectation for it to be completed in 2024. Editor’s Note: A correction has been made to the spelling of Taleen Barsoumian’s name.
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