SK Pharmteco, Inc.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Daiichi Sankyo is investing RMB 1.1 billion ($151.4 million) to build a new ADC facility in Shanghai for its oncology drug products, the company said in a Nov. 29 release. BioMarin Pharmaceutical has budgeted €60 million ($63 million) to expand its facility in Cork, Ireland, to add a new laboratory spanning four floors, the company said Monday. The site already has manufacturing capabilities in drug substance production through to packaging. Vertex has signed a memorandum of understanding with Saudi Arabia’s Ministry of Industry and Mineral Resources to localize gene therapy manufacturing, according to a Wednesday release. The agreement is expected to attract SAR 1 billion ($266 million) to the country over the next five years. EuroAPI’s CEO Ludwig de Mot has resigned . Replacing him effective immediately is chief operating officer David Seignolle, the company said Monday. Viviane Monges, director and chair of the board, has also stepped down and will be replaced by Emmanuel Blin, who joined the board in 2022. The leadership reshuffle comes amid EuroAPI’s broader restructuring . SK pharmteco is bringing together its businesses under one brand, it said Wednesday. SK biotek, SK biotek Ireland, Center for Breakthrough Medicines, Yposkesi, AMPAC Fine Chemicals and AMPAC Analytical will now all be known as SK pharmteco but will still operate individually. NorthStar Medical Radioisotopes is supplying actinium-225 to Ariceum Therapeutics for its investigational cancer asset satoreotide, according to a Wednesday release. Just last week, Ariceum also secured a supply contract for actinium-225 and lutetium-177 with isotope maker Eckert & Ziegler. Nusano will supply the radioisotope lutetium-177 to the Australian radiopharma company GlyTherix, according to a Monday release. Nusano will also supply actinium-225 once its production begins in 2026, as well as other isotopes including zirconium-89, lead-212 and terbium-161. Endo has secured FDA approval to manufacture the vasopressin injection Vasostrict at its new factory in Indore, India, the company said Monday. Production will begin in 2026.

Canadian CDMO OmniaBio, which is focused on cell and gene therapies, unveiled a new manufacturing facility near Toronto. OmniaBio, a CDMO focused on cell and gene therapies, debuted a new manufacturing facility it claims to be the largest of its kind in Canada.The 120,000-square-foot site, which is located just outside of Toronto in Hamilton, Ontario, was designed to meet the specialized needs of cold chain logistics as well as the production of cell and gene therapies with the aid of artificial intelligence, the company said in an Oct. 17 press release.The cost of the project wasn’t disclosed.The company, which was formed in 2022 and is a subsidiary of Canada’s Centre for Commercialization of Regenerative Medicine, said its AI-enabled manufacturing site will first focus on cellular immunotherapies and iPSC-based therapies.“This new facility puts us in a unique position as a specialist commercial CGT manufacturing leader tackling the toughest disease challenges head-on by combining an experienced team with advanced tools and solutions,” Mitchel Sivilotti, OmniaBio’s president and CEO, said in the release. The site’s first customer is South Korea’s Medipost, which plans to have OmniaBio manufacture its osteoarthritis drug Cartistem for North American patients. Cartistem is an allogeneic umbilical cord blood-derived mesenchymal stem cell product used to treat knee cartilage defects caused by degeneration.OmniaBio's expansion comes amid a wave of growth in the CDMO arena in the past couple of years. Just last week, Symbiosis Pharmaceutical Services and Afton Scientific announced plans to expand their sterile injectables manufacturing capacities to meet increasing demand.Other CDMOs that have announced recent production expansions include Exela Pharma Sciences, Piramal Pharma Solutions and SK pharmteco.

One of Recipharm’s main aims is the expansion of its oral solid dosage and sterile fill & finish services in sites in Europe, the U.S., Israel and India, with the aim to cover all phases of drug development from active pharmaceutical ingredient synthesis to commercial manufacturing. Recipharm began its life in 1995 as Recip and became Recipharm in 2001, numbering among the biggest CDMOs in the world in terms of revenue. In 2021, the Swedish private equity firm EQT took over Recipharm and delisted it from the Stockholm Stock Exchange. One of Recipharm’s global sites to see expansion is its small molecule center of excellence in Bengaluru, India, which has a new lab for sterile product development in addition to new labs devoted to extractables and leachables, nitrosamines and elemental impurities. This site and another in Zwickau, Germany, are also seeing advanced material characterisation equipment, a pilot-scale capsule filler, and more. Bengaluru also has a newly established development lab for sterile formulations for small molecules, while Wasserburg has a Good Manufacturing Practices (GMP) line for vials and pre-filled syringes. While much of the focus is on small molecules, Recipharm’s large molecules capacity is set to benefit from the expansion plans, including with its liquid vials, pre-filled syringes, blow-fill-seal and lyophilised products services. Recipharm’s investment “bolsters its services for early- and late-stage product development, including clinical study supply at small and pilot scales and wide range of commercial technologies,” said the company in a public release ​. googletag.cmd.push(function () { googletag.display('text-ad1'); }); The latest investments come just after Recipharm sold seven of its sites in Europe to the U.S. private equity firm Blue Wolf Capital Partners in April 2024. The company made the move as it shifted its focus ​ to oral solid dosage activity on new chemical entities, medium to high potency and on-patent drugs. In the same month, Recipharm also completed the spin-out of Bespak, an organization focused on manufacturing inhaled and nasal drugs and delivery devices. Rising prevalences of cancer and increasing outsourcing demand from growing pricing and regulatory pressures are driving ​ the global market for small molecule CDMOs, which was worth around $67.93 billion in 2023​ and is projected to soar by 7.1% per year to $108.46 billion by 2030. Another CDMO in the midst of expansion is SK pharmteco, which recently unveiled ​ a $260 million investment in its small molecule and peptide manufacturing muscle in South Korea.