Supplier News: Euroapi, Curia, Aptar, Avantor & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Euroapi, Curia, Avantor, Aptar Pharma, Lonza, Thermo Fisher Scientific, Aphena, Ancillare, Stevanato, VGXI, and Logistics4Pharma.
Chemicals/Chemical API Manufacturing
* Euroapi Expanding Peptide & Oligonucleotide Capacity
* Plasmid DNA CDMO VGXI Opens New HQ, Mfg Facility
Formulation Development/Drug Product Manufacturing
* Lonza Launches Capsule for Acid-Sensitive APIs
* Curia Breaks Ground on Fill–Finish Expansion
* Aptar Pharma Completes Phase One of $180-M Expansion
* Aphena Completes $20-M Packaging Expansion
* Stevanato, Gerresheimer Partner for Ready-to-Use Vial Platform
* Thermo Fisher To Invest $59 M To Expand Clinical Research Lab
* Avantor Opens New Distribution Center in Ireland
* Ancillare Appoints New President
* Logistics4Pharma Expands Warehouse Services
Chemicals/Chemical API Manufacturing
Euroapi Expanding Peptide & Oligonucleotide Capacity
Euroapi, a Paris-based CDMO of small-molecule active pharmaceutical ingredients and intermediates, spun off from Sanofi earlier this year (2022), has announced an EUR 18 million ($17.8 million) investment for the installation of manufacturing equipment at its site in Frankfurt, Germany, to increase production capacity for peptides and oligonucleotides.
The investment will debottleneck current capacity with the goal of increase the company’s peptide and oligonucleotide output to 500 kilograms per year by 2025. The investment will be made in several stages, and capacity could also be further enhanced in the future with additional limited investment. Euroapi is currently working on 14 CDMO large-molecule projects, including peptides, oligonucleotides and lipids, as part of a portfolio of 64 projects, as of June 30, 2022.
Plasmid DNA CDMO VGXI Opens New HQ, Mfg Facility
VGXI, a Conroe, Texas-based CDMO of nucleic acid-based biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, has opened a new headquarters and manufacturing facility in Conroe, Texas. The new facility is 120,000 square feet, and the company is now booking 2023 GMP manufacturing slots at fermentation scales from 10 L to 1500 L across multiple independent manufacturing trains. Dedicated areas are also available for personalized immunotherapy indications and GMP mRNA production.
Formulation Development/Drug Product Manufacturing
Curia Breaks Ground on Fill–Finish Expansion
Curia has broken ground to expand its site in Albuquerque, New Mexico, to add additional space for a high-speed fill–finish vial line that will provide Biosafety Level 2 containment. The expansion also includes two lyophilizers and a flexible filling line for vials, syringes, and cartridges to support smaller-batch advanced therapies. The flexible filling line and high-speed fill-finish vial line are planned to be operational in 2025.
The expansion is part of an agreement with the US government to support the domestic production of injectable medicines. The agreement is with three federal entities: (1) the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response at the US Department of Health and Human Services; (2) the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense; and (3) the US Army Contracting Command’s Joint COVID Response Division. The State of New Mexico is also supporting the expansion through assistance from the Local Economic Development Act job creation fund. Curia is also eligible for state assistance for employee job training from New Mexico’s Job Training Incentive Program.
Lonza Launches Capsule for Acid-Sensitive APIs
Lonza has launched a capsule, Capsugel Enprotect, for intestinal (enteric) drug delivery of acid-sensitive active pharmaceutical ingredients. The capsule does not disintegrate during stomach transit and only releases its contents in the intestine and can be use with small molecules, peptides, proteins, and RNA-based therapeutics.
Aptar Pharma Completes Phase One of $180-M Expansion
Aptar Pharma, a provider of drug-delivery systems and services, has completed the first phase of a $180-milllion expansion to increase capacity of injection component units. The expansion project began in 2020 to boost capacity across all product lines, and when fully completed, will enable production of over 10 billion injectable component units annually. The expansion involves increased manufacturing capacity for Aptar Pharma’s PremiumCoat ETFE film-coated components and its PremiumFill elastomer components and vial stoppers.
The expansion program includes the addition of 23,000+ m² of manufacturing space at the company’s sites in France and the US. The first phase of the capacity expansion is already operational in Granville, France, and includes new ISO7 cleanrooms and advanced robotics. An additional plant in Granville, France, will be operational in early 2024. US-based manufacturing capabilities will also be operational as of 2024. Further manufacturing expansion phases in both the US and France are also included in the program.
Source: Aptar Pharma
Aphena Completes $20-M Packaging Expansion
Aphena Pharma Solutions, a Cookeville, Tennessee-based provider of contract packaging services, has completed a $20-million expansion and renovation of its Cookeville, Tennessee, facility to increase solid-dose packaging capacity. The expansion added a new 500,000-square-foot facility with the addition four additional high-speed bottling lines and two additional high-speed blister lines for solid-dosage products.
Source: Aphena Pharma Solutions
Stevanato, Gerresheimer Partner Ready-to-Use Vial Platform
Stevanato Group, a Padua, Italy-based provider of drug-containment, drug-delivery, and diagnostic products and services, and Gerresheimer, a provider of drug packaging and drug-delivery systems, have partnered for a new ready-to-use (RTU) vial platform, EZ-fill Smart, which builds on Stevanato’s proprietary RTU vials, EZ-fill.
The EZ-fill Smart platform uses increased automation throughout manufacturing, features no glass-to-glass and no glass-to-metal contact to improve quality and integrity of the vials throughout the product life cycle, and uses an alternative sterilization method than the traditional method of sterilization using ethylene oxide.
EZ-fill Smart with nest & tub configuration, including process and product optimization, is expected to be available for commercial use during the first half of 2024. By mid-2023, the new platform is expected to be available to customers for initial validation. EZ-fill Smart with tray configuration for high volumes is expected to be available during the first half of 2024.
Separately, Stevanato has formed a non-exclusive distribution agreement with DWK Life Sciences, a Wertheim, Germany-based manufacturer of laboratory glassware and pharmaceutical primary packaging materials, for Stevanato’s EZ-fill, proprietary RTU pre-sterilized vials, particularly EZ-fill vials in nest & tub and trays and cartridges in nest & tub.
Thermo Fisher To Invest $59 M To Expand Clinical Research Lab
Thermo Fisher Scientific, through its PPD clinical research business, has announced a $59-million investment to expand its laboratory operations in Highland Heights, Kentucky.
The current 71,600-square-foot facility, which includes central lab and biomarker operations, will be expanded to 114,000 square feet to add sample-management and testing capacity to support new therapeutics, including vaccines and cell and gene therapies. The expansion is expected to be completed in stages by the end of 2024 and will add 200 new jobs over the next five years. The current operation employs nearly 650 Ph.D.-level scientists, analytical laboratory staff, and other scientific and support professionals.
Source: Thermo Fisher Scientific
Avantor Opens New Distribution Center in Ireland
Avantor, a distributor and supplier of products and services to the bio/pharmaceutical industry, has opened a new 69,000-square-foot distribution center in Dublin, Ireland. The new facility provides cGMP warehousing, onsite cleanrooms, batch-to-batch traceability, custom palletization, inbound and outbound product quality inspections, and vendor-managed inventory services. The distribution center is Avantor’s second in Ireland, adding to its current footprint of 76,000 square feet. The facility will also create 40 new jobs, adding to the 200 employees the company currently employs in Ireland. The site is part of a global footprint that includes more than 200 manufacturing, distribution and sales centers in over 30 countries.
Ancillare Appoints New President
Ancillare, a Horsham, Pennysylvania-based provider of clinical trial material supply-chain services, has appointed Jason Monteleone as its new President. He most recently served as Chief Business and Strategy Officer at dMed-Clinipace, a global mid-sized CRO and currently serves as a Board Observer for the Drug Information Association. Overall, Monteleone has more than 25 years of experience in the healthcare, medical device, and life-sciences industries.
Logistics4Pharma Expands Warehouse Services
Logistics4Pharma, a pharmaceutical cold-chain packaging, storage, warehousing, and logistics specialist, reports that its facility near the Frankfurt Airport in Germany has been GDP-bonded for GDP warehouse services. The services offered by the facility include: a range of controlled temperatures from -80 degrees Celsius, to +25 degrees Celsius; passive and active packaging; temperature-controlled logistics by air, land, and sea across the same range of temperatures; customs clearance services; and cross-docking services and customized kit assembly services for medical devices suppliers and for clinical trials.