Supplier News:, Euroapi, Seqens, Mikart & More
The latest from CDMOs, CMOs, and suppliers featuring Euroapi, Seqens, Mikart, Vector BioMed, Sanner, and Jones Healthcare.
Chemicals/Chemical API Manufacturing
* Euroapi Resumes Prostaglandin Production at Budapest Site
* Seqens Opens R&D Center
Biologics Manufacturing
* Vector BioMed Debuts as New Viral Vector CDMO
Formulation Development/Drug Product Manufacturing
* Mikart Completes Mfg Suite for Liquids and Suspensions
Packaging
* Sanner Breaks Ground on Germany HQ & Production Site, China Mfg Facility
* Jones Healthcare Adds Capacity for Complex Folding Cartons
Chemicals/Chemical API Manufacturing
Euroapi Resumes Prostaglandin Production at Budapest Site
Euroapi, a Paris-headquartered CDMO of small-molecule active pharmaceutical ingredients and intermediates, spun off from Sanofi last year (2022), restarted prostaglandin production at its site in Budapest, Hungary, on January 19, 2023.
The company had temporarily suspended production in December 2022 following identifying certain GMP deficiencies related to production documentation during an internal assessment.
Euroapi says it has built and successfully implemented a remediation plan to allow it to progressively restart some prostaglandin production beginning this month (January 2023). The company expects the majority of prostaglandin production to be back on line by mid-April 2023.
No other activities at the Budapest site were impacted, including CDMO activities.
Source: Euroapi
Seqens Opens R&D Center
Seqens, a CDMO of active pharmaceutical ingredients (APIs) and intermediates, has opened Seqens Boston R&D Center, a 15,000-square-foot R&D Center of Excellence in Devens, Massachusetts. It will serve as one of the company’s global centers of excellence.
The facility, built with a $5-million investment, replaces an older, smaller R&D facility in Devens, and all current employees have moved to the new lab. Seqens plans to double the number of scientists there by 2026.
The Seqens Boston R&D Center is designed to expand project flow, enhance quality, and accelerates development of APIs and excipients, including lipids used for the manufacture of RNA vaccines for COVID. It will serve as the North American flagship center for Seqens’ global R&D network, which consists of 10 R&D centers across Europe and North America and 300-plus scientists.
In addition, the company is investing in flow chemistry and biocatalysis to speed development of custom polymers, lipids, and high potency APIs. To combat a shortage of the pain reliever paracetamol, known as acetaminophen in the US, Seqens is currently building a plant in France to produce over half of Europe’s paracetamol needs.
Source: Seqens
Biologics Manufacturing
Vector BioMed Debuts as New Viral Vector CDMO
Vector BioMed, a Gaithersburg, Maryland-based biomanufacturing company specializing in the manufacture of lentiviral vectors, has announced its launch and first financing round led by Viking Global Investors and Casdin Capital, two investment firms. The funds will support the company’s operations to provide rapid access to high-quality lentiviral vectors for preclinical development, clinical trials, and commercialization.
In conjunction with the funding and launch, co-founder Boro Dropulić, PhD, has been named CEO of Vector BioMed. He has more than 30 years of leadership and experience in the design, development, manufacturing, clinical translation, regulatory, clinical implementation, and commercialization of lentiviral vector technology. Among his career accomplishments, Dr. Dropulić led the team that first demonstrated the safety of lentiviral vectors in humans with his colleagues at the University of Pennsylvania. Later he founded Lentigen, which developed the lentiviral vector used to produce Kymriah, the first FDA-approved gene therapy product.
Source: Vector Biomed
Formulation Development/Drug Product Manufacturing
Mikart Completes Mfg Suite for Liquids and Suspensions
Mikart, an Atlanta, Georgia-based CDMO of drug products, has completed a new liquids and suspensions manufacturing suite at its site in Atlanta, Georgia.
The suite has a variety of temperature-controlled tanks that support a wide diversity of volumes ranging from 50 L to 4,000 L. The facility suite will be capable of manufacturing complex suspension products, including extended-release products. The investment further supports the company’s geriatric and pediatric product development and manufacturing capabilities.
Source: Mikart
Packaging
Sanner Breaks Ground on Germany HQ & Production Site, China Mfg Facility
The Sanner Group, a Bensheim, Germany-based provider of pharmaceutical packaging, has broken ground on a new production site and headquarters in Bensheim, Germany, and a second manufacturing facility in Kunshan, China, which is due to start production this summer (summer 2023)
The new German site will have 30,000-square-meters of production floor, doubling Sanner’s existing German capacity. New, highly automated equipment will further increase production capacity by \more than 100%. The new facility will have the following capabilities: (1) 300 square meters for a new technology and innovation center; (2) separate desiccant and injection molding areas; (3) a molding and assembly production floor; (4) an automated central material supply to feed all machines; (5) Class 7 and 8 cleanroom capacity; (6) ESD floors for electronic medical device components; and (7)a doubling of current warehouse capacity with a an automated stock-management system.
In China, Sanner will start production in a new facility in summer 2023, and the existing factory in Kunshan will continue to operate in parallel. The new site will have the following capabilities: (1) 4,000 additional square meters of production space; (2) Class D cleanrooms for GMP-compliant production of pharmaceutical and medical packaging; (3) warehouse, workshop, and office areas; and (4) automation and energy-saving systems for production processes.
Source: Sanner
Jones Healthcare Adds Capacity for Complex Folding Cartons
Jones Healthcare Group, a London, Ontario-based provider of packaging and medication dispensing products, has installed a new flatbed die-cutter to increase the company’s production efficiency and capacity for complex folding cartons. The company said that the machinery is part of a $30-million equipment investment. The 250-ton die-cutter increases efficiency through in-line blanking separation and dynamic stripping at high speeds, producing up to 8,000 sheets per hour.
Source: Jones Healthcare Group
