Manufacturing roundup: Actylis opens the doors to a facility in Oregon; Emergent reports Q4 numbers

02 Mar 2023
endpts.com
VaccineFinancial Statement
The ingredients manufacturer Actylis has opened a new 30,000-square-foot facility in the city of Eugene, OR. Actylis CEO Gilles Cottier said in a statement the new site will allow the company to manufacture APIs and intermediates for clinical trials — and on a commercial scale. “We designed this facility specifically to enable us to develop and produce innovative APIs for our customers. Our intimate knowledge of their needs, our consultative approach, and our focus on innovation offer unparalleled choice and flexibility,” Cottier added. Site director Christine Bellmor also stated in the release that the new facility has seven manufacturing suites, as well as different reactors to allow for a variety of products to be made. “Commissioning and qualifications for clinical GMP were completed at the end of January this year and we already have our first projects completed and more are underway. The new facility is a 10-minute drive from our R&D facility which is critical for scaling and developing new processes for the plant,” Bellmor said. The manufacturer Emergent hit some bumps in the road in its end-of-year financial results. In Q4, Emergent had $330.7 million in revenue, down from $723.2 million in the previous quarter. The manufacturer also reported a net loss of $88 million in the quarter and $224 million for the fiscal year. It also saw a decrease in sales of its nasal naloxone and anthrax vaccines. For its CDMO business, revenues for the quarter decreased by $33.5 million compared with Q4 of 2021. Emergent said in its earnings release that it received no revenue from its AstraZeneca or Janssen contracts after those contracts were severed in 2021 and 2022. The drop also related to less production at its Camden facility in Maryland. Emergent emphasized that it is investing in boosting compliance and quality at the site, which reduced its ability to manufacture there. However, Emergent did see some revenue earned at its facility in Winnipeg, Canada. “Our 2022 performance reflects the transition the company is undergoing and, together with our 2023 forecast, stands as a baseline from which we will grow post-pandemic. Moving forward, our strategy will continue to put patients and customers first and support governments and their public health preparedness and response capabilities while returning Emergent to sustainable long-term growth and profitability,” CEO and president Robert Kramer said in the release. The oligonucleotide producer Oglio Factory has opened the doors to a new manufacturing site and HQ in Holliston, MA. The 13,000-square-foot site will have offices and labs, and will boost its manufacturing capacity by 12x, according to a release from Oglio Factory. The company also recently received growth capital from Research Corporation Technologies and BroadOak Capital Partners. “This additional capacity along with the speed and efficiency of our synthesis process will enable us to scale with our customer’s needs and market demands,” said Oglio Factory CEO Chris Boggess in a statement. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) has managed to rake in $1.7 million in planned activities through its Global Health Fund project. The planned activity, according to a release , will have NIIMBL working on three new projects related to developing vaccines related to mRNA and viral vector technology. The projects were chosen by NIIMBL and the Bill and Melinda Gates Foundation. The Global Health Fund also has funding contributed by the foundation as well. The fund has the objective of developing new technologies for vaccines and biologics manufacturing. “NIIMBL is looking forward to adding these key projects to our GHF portfolio. These projects will allow us to further advance innovation in vaccine manufacturing, particularly around potency assays that are important for the characterization of key quality aspects of vaccines,” NIIMBL Associate Institute Director Chris Roberts said. R&D outfit Yinjia Bioscience and the CDMO Porton Advanced Solutions have developed a partnership to develop raw materials for cell and gene therapy production. According to a release , the partnership will also test products for quality and evaluate ways to accelerate the development and eventual commercialization of cell and gene therapies. The deal itself will see Yinjia provide Porton with the raw materials and testing products. Porton’s role will be to build out its technology and capabilities for making cell and gene therapies for its clients. “We are glad to establish a strategic partnership with Yinjia Biosciences,” Porton CEO Wang Yangzhou said in a statement, adding that the partnership “will strengthen Porton Advanced’s CGT CDMO and accelerate the development of innovative CGT therapeutics to deliver life-changing benefits to patients.” Two CDMOs that came together last year are looking to build out more manufacturing suites. Both RoslinCT and Lykan Bioscience will add six new cGMP processing suites to a facility in Hopkinton, MA. The move is being made due to industry demand, the companies said in a statement. Once completed, the expansion will bring the capacity to 22 total cGMP suites between the companies, with 14 in Massachusetts and eight in Edinburgh, UK. The new suites will be designed to meet US and EU regulatory requirements. The expansion also included an automated processing room for making both allogenic and autologous products. Lykan CEO Patrick Lucy added in a release that the expansion will increase the company’s capacity by 75%. “This expansion builds on RoslinCT and Lykan’s expertise and marks another significant milestone in our collaboration. The additional capacity at Lykan’s facility in Hopkinton will allow us to continue delivering cutting-edge products, enabling our clients to offer life-changing therapies to patients around the world and meet the increasing demand for innovative therapies,” Rosin CEO Peter Coleman said in a statement. GenScript will be expanding its facility in Singapore to provide wider gene synthesis services. The company will be adding 976 square meters, or over 10,000 square feet, to bring its total production space to 3,500 square meters, or over 37,000 square feet. The expansion will also bring the headcount to over 150, with the facility also producing recombinant proteins. The facility will have the capability of synthesizing more than 400 genes per day — while also aiming to reduce turnaround times for projects. Ultimately, the expansion will look to support research in cell and gene therapies and vaccine development. “As we continue to expand our global footprint, we remain dedicated to providing the highest quality products and services to our customers, wherever they may be located,” Ray Chen, president of GenScript’s Life Science Group, said in a release . Shanghai ChemPartner has named Lilly Xu as the president of CDMO Shanghai ChemPartner. Xu has been with the company since 2017 and has led the drug discovery services as the SVP and head of DMPK and exploratory toxicology. Before joining the company, Xu held positions at companies such as Amgen and Sanofi, in the US. At Sanofi’s US branch, she was the head of the center for predictive ADMET. “I am excited to take on this new leadership role at ChemPartner and work closely with our highly experienced executive team to achieve our company’s vision and goals. My drug discovery and development operation experience combined with the team’s expertise provides ChemPartner’s global clients the skills and proficiency they want and need,” she said in a release .
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