AGC Biologics SpA

WALNUT CREEK, Calif., Oct. 07, 2024 (GLOBE NEWSWIRE) -- Dark Horse Consulting Group (“DHC”), the leading global consultancy to the cell and gene therapy (“CGT”) industry, today unveils the Initiative for Certification of Manufacturing Capabilities (“ICMC™”), a groundbreaking offering designed to close a critical gap in the CGT CDMO market. ICMC was conceptualized as a way to meet the growing demand for transparency and consistency in the rapidly expanding CGT CDMO landscape. Currently, new service providers are entering a market where their claims of providing compliant and scalable manufacturing services are not proactively verified by the relevant regulatory bodies. As such, the CDMO market is experiencing fragmentation and the perception of a diminished outsourcing value. With an industry-leading track record in supporting both CGT therapeutic developers and manufacturing organizations, DHC is uniquely positioned to deliver credible and unbiased evaluations in order to help drug developers make informed decisions in selecting their manufacturing partner. DHC maintains a global database of CGT CDMOs and in the past 4 years has performed more than 50 CGT CDMO selection projects, more than 40 audits, and over 60 remediation projects. The ICMC program offers the opportunity for CDMOs to opt-in to independent, third-party evaluations across nine capability systems following published criteria, ensuring a fair, objective, and comprehensive certification into the Certified Member Directory. This Directory is publicly available, providing developers with a trusted resource for initiating the selection of credible manufacturing partners. “With ICMC, we are setting a new benchmark for transparency and trust in the CDMO marketplace,” said Anthony Davies, DHC Founder and CEO. “Sponsors often struggle to find credible, unbiased information when choosing a CDMO. ICMC is designed to help by providing a list of vendors with verified capabilities as a starting point for sponsors’ CDMO selection process.” Key benefits of the ICMC program include: Credibility: ICMC Certification builds trust between therapeutic developers and prospective CDMO partnersDifferentiation: ICMC Certification highlights the extent of capabilities that exist within the member CDMOsVisibility: The ICMC Certified Member Directory enables identification of credible manufacturing partners Several early adopter partners—including ElevateBio, AGC Biologics, and Andelyn Biosciences—have already joined the program and the certification process has commenced. Discussions are ongoing with a number of additional prospective members. About Dark Horse Consulting Group Dark Horse Consulting Group, a global company with offices in the U.S., U.K., and Singapore, was founded in 2014 with the purpose of accelerating cell and gene therapies through unmatched consulting expertise. DHC’s collective knowledge spans product and process development, analytical development, device development, facilities, manufacturing & compliance, quality assurance, project & program management, regulatory affairs, nonclinical development, clinical regulatory, quantitative modeling, market expertise, and diligence & business strategy. DHC offers an unmatched understanding of the challenges faced by cell and gene therapy developers and applies best practices from this and other industries to address a diverse range of client needs. A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c1977410-6ac8-402c-a8a5-0f68549fe5b9

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. AGC Biologics said it is laying off a total of 95 staffers, which will be effective from November. The manufacturing company is cutting 80 workers in Colorado, 63 of whom are in Longmont and 17 are in Boulder. Another 10 staffers will be cut in Bothell, WA. The company’s Longmont factory will remain “partially open,” according to a WARN notice published last week. Lonza has become the third publicly announced manufacturer to make Vertex Pharmaceuticals’ Casgevy, according to a Tuesday release. Lonza will make commercial Casgevy at its facility in Geleen, the Netherlands, with plans to also make it in Portsmouth, NH, in 2025. RoslinCT and Charles River Laboratories are the other two companies previously tapped by Vertex to make the gene therapy. Eurofins CDMO Alphora is building a new 50,000 square foot facility to manufacture monoclonal antibodies and protein-based therapies, the company said Tuesday. The new site at Eurofins’ Sheridan Research Park campus in Ontario will open in April 2026. The Canadian government has contributed $64.1 million to help Eurofins build the factory. Bavarian Nordic has secured $63 million from the Biomedical Advanced Research and Development Authority to manufacture its smallpox and mpox vaccine Jynneos. The vaccines will be manufactured next year for rollout in 2026, according to a Tuesday announcement. Thermo Fisher Scientific is expanding its factories in Cincinnati, OH, and Bend, OR, to boost its oral solid dose manufacturing capacity. The facility in Bend will double its footprint and house R&D manufacturing and testing for oral solid doses, the company said Thursday. Legend Biotech will evaluate Multiply Labs’ robotic technology in its potential to manufacture cell therapies, the companies announced Tuesday. Capricor Therapeutics has established internal commercial manufacturing for its Duchenne muscular dystrophy cardiomyopathy asset named deramiocel. The company is planning to submit a biologics license application to the FDA in October, the company said Tuesday. Private equity firm Blue Wolf Capital Partners has completed its acquisition of seven manufacturing facilities in Europe from the CDMO Recipharm, according to a Wednesday release. The acquisition was first announced in April. Ophthalmic pharma company Harrow is expanding its headquarters in Nashville and will hire an additional 150 people, the company said Wednesday. Lonza has extended its collaboration with Acumen Pharmaceuticals to manufacture the Phase 2 asset sabirnetug, which is being investigated for Alzheimer’s disease, the companies said Thursday. Acumen originally tapped Lonza to make sabirnetug in April. CDMO SK pharmteco and supply chain logistics company Cryoport announced a new partnership Wednesday. Cryoport will handle SK pharmteco’s supply chains for small molecules and cell and gene therapies, including shipping and collecting materials.

An AGC spokesperson stressed that the decision to idle the Longmont plant does not mean the facility is being sold off. Instead, AGC is pausing most operations as it rethinks its strategy in the small Colorado town and keeps a “close eye on the nascent cell & gene therapy market.” As CDMOs across the industry continue to face pressure from a fluctuating biopharma business environment, AGC Biologics is charting another round of staff cuts and pumping the brakes at one of its chief U.S. facilities.As part of the new restructuring push, AGC will lay off 68 employees at its cell and gene therapy plant in Longmont, Colorado, 17 employees at its commercial mammalian plant in Boulder, Colorado, and 10 employees in Bothell, Washington, according to a Worker Adjustment and Retraining Notification (WARN) alert.The job cuts, which largely affect manufacturing workers, are set to go into effect Nov. 22, according to the notice.AGC confirmed the move over email, pointing to the biopharma industry's spending cuts that have weighed heavily on CDMOs and other manufacturers.“With that, AGC Biologics has evaluated our resources and made the difficult decision to idle most operations at one of our global sites, the AGC Biologics cell and gene therapy plant in Longmont and restructure some U.S. and global support functions,” a company spokesperson explained. The decision does not mean the Longmont facility is being sold off, the spokesperson said. Instead, AGC is pausing most operations as it rethinks its strategy in the small Colorado town and keeps a “close eye on the nascent cell & gene therapy market.”While most production functions are temporarily winding down, the Longmont warehouse, quality control labs and “some office space” will remain operational, the spokesperson added.AGC established its presence in Longmont—some 16 miles from the company’s mammalian facility in Boulder—with the purchase of a Novartis Gene Therapies plant in the summer of 2021.The 622,000-square-foot facility is the largest commercial cell and gene therapy manufacturing plant in AGC’s network and currently employs more than 150 people, according to the company’s website.Jobs getting the chop in Longmont include manufacturing supervisors, managers and associates as well as workers in quality control, engineering and more, the WARN alert states.AGC’s spokesperson said the company doesn’t make layoff decisions lightly and will support both employees and customers through the change. Staffers affected by the cuts will receive comprehensive severance packages, the spokesperson added. The latest round of cuts follows AGC’s decision to lay off just under 4% of its global workforce back in May.Citing “changing economies” and “other external factors” affecting AGC Biologics and many of its manufacturing partners, the CDMO's spokesperson told Fierce at the time that the company had reached an inflection point and needed to adjust business priorities and “right size and rebalance the resources of our organization.”