Manufacturing roundup: Life sciences development planned for Texas; Eli Lilly to supply insulin ingredient to Bangladesh

16 Feb 2023
endpts.com
Phase 2
New life science and production facilities may be coming to a Dallas, TX suburb. Investment company NexPoint has announced plans for a 200-acre life science development in Plano, TX. Dubbed the TxS District, meaning Technology x Science, the site will include four million square feet of lab, office and manufacturing space. According to a spokesperson, in an email to Endpoints News, the site is planning to begin construction later in the year and will take around six to seven years to complete. The spokesperson also said that the project has a “multibillion-dollar proposed budget,” and NexPoint is working with the city of Plano on the plans. And, according to the release, NexPoint had purchased the site for the main campus back in 2018 and has been buying additional acreage since then. As for the manufacturing space, the spokesperson told Endpoints that several production facilities and a cold storage facility are in the current proposal. The production sites are also more geared towards the development and production of cell and gene therapies. The release states that around 970,000 square feet will be converted into lab and office space, while 120,000 feet will be used for amenities. The site also plans to include a public park and an amphitheater. Pharma giant Eli Lilly will be selling its active pharmaceutical ingredient (API) for insulin at a reduced cost. The sale, which will be going to International Agencies (Bangladesh), is part of an effort to increase access to and boost the affordability of insulin for people living with diabetes in Bangladesh by 2030. IABL’s role, according to a release, will be to formulate and finish the insulin vials under its own trademark and brand by 2025. The insulin produced by them will only be for the Bangladeshi market as well. Lilly has been stepping up efforts to make affordable insulin more available. In December of last year, it partnered with Egypt-based Eva Pharma to not only supply it with Lilly’s API for insulin but to provide a technology transfer to the company for Eva to fill and finish the product and make it available for the African market. “Lilly is committed to addressing the critical gaps in access to essential medicines for people living with diabetes in low- and middle-income countries. Through collaborations like this one with IABL, we are working to reduce barriers to access and ensure ongoing production and uninterrupted supply of insulin so that a greater number of patients can live healthier lives,” said Ilya Yuffa, president of Lilly International, in a release . The biotech VBL Therapeutics will be looking to get some extra cash by selling off its manufacturing facility in Modi’in, Israel. The sale of the facility, other assets and equipment will net the company $7.1 million in cash. The sale of the facility is estimated to close around March 9 of this year. The buyer for the facility has not been disclosed. “As part of our previously announced strategic process, we have been seeking ways to unlock value from our assets and the monetization of our state-of-the-art facility was one of our key priorities to maximize shareholder value,” said Dror Harats, CEO of VBL, in a statement . The Indian manufacturer Global Pharma Healthcare has been given an import alert from the FDA. The alert comes when an inspection of manufacturers is being performed, and the FDA determines that the company is not operating with good manufacturing practices. This alert can lead to the detention of drug products in the US. For Global Pharma Healthcare, 10 products that were manufactured at its facility in Thiruporur, India, were placed under alert, which includes antibiotics and unnamed drug products meant for humans and animals. The company is also facing a voluntary recall of its artificial tears eye drops due to the possibility of contamination. According to the FDA report on the recall, there have so far been 55 reports of adverse events that include infection, loss of vision and a death from a bloodstream infection. The drops were distributed by EzriCare and Delsam Pharma. The Indian manufacturer Piramal Pharma has started API production at new suites at its manufacturing facility in Riverview, MI. According to the CDMO, construction on the expansion started in 2021, for $38 million. The facility now has around 25,000 square feet of space and has now has more production and warehousing space. Piramal plans to add more reactor bays in Phase 2 of the expansion, dubbed project PRIME. Piramal also capped off an expansion at its API facility in Aurora, Ontario, Canada, that saw 10,000 square feet of manufacturing space added to the tune of CAD 30 million ($22.3 million). “Getting Project PRIME Phase 1 online is an important milestone for Piramal Pharma Solutions and the Riverview site team. It brings additional capacity to our North American offering, which we believe satisfies the market’s current high demand for APIs. It also addresses the industry trend for onshoring of drug substance production,” said Piramal CEO Peter DeYoung, in a release . Manufacturing giant Lonza will be looking to one of biotech’s beating hearts for an expansion. According to a release sent to Endpoints , Lonza will be putting a new lab for its early development services in Cambridge, MA. The 17,000-square-foot facility is slated to begin operations in May of this year. Its early development services aim to assist customers in the starting stages of development, assessing issues with candidates before they head to trial. The early development services arm already has a lab in the UK. The manufacturer also finished the expansion it its bioconjugation facility in Visp, Switzerland. That expansion includes two new manufacturing suites, among other infrastructure. “Combined with our offerings across drug substance and drug product manufacturing in small molecules and biologics, our bioconjugation services can support projects from early phase through to late-stage and commercial programs,” said Stefan Egli, the head of bioconjugation at Lonza, in a release sent to Endpoints . Catalent has capped off a $2.2 million expansion to its clinical supply facility in Singapore. The facility, now at 31,000 square feet, now has the space to install 35 new freezers for ultra-low temperature storage as well as more room for packaging products. The new ultra-low capabilities will allow for the facility to handle mRNA-based vaccines as well as cell and gene therapies. “The Singapore site was the first Catalent clinical supply facility in the Asia-Pacific region, and now serves as a strategic supply hub, shipping clinical materials with high reliability and speed to over 20 countries,” said Tracey Clare, general manager of APAC operations for Catalent, in a release . The cell therapy CDMO Theragent has inked a contract with AI software company Insight68. The deal will digitize all paper records, which can also be tracked in real-time and plans to digitalize and streamline Theragent’s cell therapy manufacturing process. The addition of the AI software will not only cut down on paper usage, according to a release sent to Endpoints but also allow the manufacturer to scale production and organize schedules for customers’ clinical trials and will automate other operations such as ordering and planning. “Theragent and Insight68’s exclusive agreement will give Theragent a profound ability to eliminate manufacturing inefficiencies and provide vein-to-vein transparency to our clients, unlike other cell and gene therapy CDMOs,” said Jeff Masten, COO of Theragent, in a release . No financial information or timelines for when the software will be installed have been disclosed. The Australian CDMO AcuraBio will be augmenting its services to include manufacturing plasmid DNA. AcuraBio’s plasmid service will use technology from Cytiva and expects to produce more plasmids using the tech. However, the wider details of production were not disclosed. In a release, AcuraBio CEO Guillaume Herry said that the access and production of plasmid DNA are in the middle of a bottleneck and that this move will bring more plasmid DNA quicker to customers in the mRNA and viral vector market. “The adoption of Cytiva’s FlexFactory configurable manufacturing train, within AcuraBio’s assets, will enable AcuraBio to advance and better serve their customers based with efficient and flexible cGMP manufacturing services that address the increasing demand for high-quality therapeutics within the Australia and New Zealand region and beyond,” said Jon Ince, Cytiva’s general manager for commercial in Australia and New Zealand, in a release . Maryland-based Regenxbio has lifted the veil on a Phase II bridging study. The data, which will be presented in full at a conference later this year, evaluated its candidate RGX-314 in 60 patients with wet AMD. The primary endpoint is protein concentration in the eye at month six. So far, Regenxbio has reported that the candidate is well tolerated in 46 patients, with five adverse effects reported but not related to RGX-314. “The interim results observed in the Phase II bridging study show a similar clinical profile between our manufacturing processes. We believe our approach, focused on early product quality and process control, allows us to efficiently transition from clinical trials to commercial readiness,” said Regenxbio COO Curran Simpson in a release . The candidate is being developed in partnership with AbbVie and is designed to produce vectors that can be used in a variety of therapeutics. Altasciences is adding to its team on two continents. Peter Varney will join Altasciences as the pharma development and strategy advisor. Varney has 40 years of experience in the commercial development and relationship management space. Hazel Clay will be brought on as a drug development advisor. Clay brings 30 years of development experience and both employees will be based at Altascience’s office in Harrogate, UK. The manufacturer has also brought on Lisa Biegel as the senior scientific director of preclinical services, who will be working out of its facility in Columbia, MO. According to the Altasciences release, Biegel will provide oversight and scientific input to the reporting and study direction teams at the facility. Annette Kenser will also be joining the company as the senior director of quality assurance and preclinical research focusing on quality and making improvements where necessary. Editors Note: A previous version of this story had incorrectly labeled Curran Simpson as CEO of Regenxbio.
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