Supplier News: Cambrex, Fujifilm Diosynth, Vetter & More
The latest from CDMOs, CMOs, and suppliers featuring Cambrex, Fujifilm Diosynth Biotechnologies, Vetter Quotient Sciences, Univar, Recipharm, BD, Corium Pharma Solutions, Ardena, Andelyn Biosciences, Aragen, Scorpion Biological Services, and Altasciences.
Chemicals/Chemical API Manufacturing
* Cambrex Investing $16.5 M To Expand Small-Molecule API Development, Mfg
* Ardena To Expand Drug-Substance Mfg Facility
* Quotient Sciences Completes Expansion of Drug-Substance Mfg Facility
* Univar Adds Four Pharma Ingredient Labs
* Fujifilm Diosynth Breaks Ground on Mfg Expansion for Advanced Therapies & Vaccines
* Andelyn Biosciences Opens Gene-Therapy Mfg Facility
* Scorpion Opens Biologic Mfg Facility
Formulation Development/Drug Product Manufacturing
* Vetter Commissions New $20-M Warehouse
* Corium Pharma Solutions Formed as New CDMO
* Aragen To Open New Formulation Mfg Facility in 2023
* Recipharm Investing in New Sterile Filling Line & Low-Volume Blow-Fill-Seal Filling
* Altasciences Expanding Bioanalytical Lab
* BD, Biocorp in Pact for Connectivity, Traceability for Injectable Drugs
Chemicals/Chemical API Manufacturing
Cambrex Investing $16.5 M To Expand Small-Molecule API Development, Mfg
Cambrex is investing $16.5 million in a new, 21,000-square-foot research and development facility in Minneapolis, Minnesota, to expand its capacity for small-molecule drug development and manufacturing and to expand its active pharmaceutical ingredient (API) manufacturing site in Charles City, Iowa.
The new facility in Minneapolis will specialize in analytical and chemical development for drug candidates and will operate as an extension of Cambrex’s facility in Charles City, where the company will simultaneously launch a multi-phase, 9,000-square-foot expansion and 21,000-square-foot renovation project. The expansion in Charles City will add a new quality control laboratory and administrative office space, which will bring 40 new jobs at the site. The renovations will enhance and modernize the existing quality control and research and development facilities.
The investment follows an earlier $50-million expansion in Charles City that was completed in the first quarter of 2022. The facility in Charles City is located on a 45-acre property and produces APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances.
Ardena To Expand Drug-Substance Mfg Facility
Ardena, a Ghent, Belgium-based CDMO of drug substances and drug products, has announced an expansion of drug-substance manufacturing capacity at its facility in Södertälje, Sweden as part of an EUR 35-million ($35.2-million) investment across its European operations.
The company is adding a new production line, a larger preparative high-performance liquid chromatography (HPLC) system, a new lyophilization unit, and additional large-scale synthesis equipment. Scheduled to be installed and qualified in the fourth quarter of 2022, the increased capacity will allow for a production speed four times higher than with the current preparative HPLC. A new tangential flow filtration/ultrafiltration will offer purification and concentration of APIs and chemical compounds using a continuous process design. Lyophilization up to 55 liters for improved concentration and isolation of pure materials will be operational in 2023. Synthesis equipment ranging from 50 liters to 2,300 liters will also be upgraded with more reactors. Overall, the facility will increase from a 1,500-square-meter building to a total footprint of over 4,000 square meters for labs and office space by the end of 2023.
Quotient Sciences Completes Expansion of Drug-Substance Mfg Facility
Quotient Sciences, a Nottingham, UK-based CDMO of drug substances and drug products, has completed a £6 million ($7 million) expansion of its drug-substance manufacturing facility in Alnwick, UK.
The expansion provides multi-purpose capacity of up to 15 GMP reactor streams with reactor volumes ranging from 5 liters up to 150 liters and deployment of batch or continuous flow chemistry technologies. The facility has been designed with a predictive-process control system to improve the transfer from small-scale process R&D into manufacture of multi-kilogram quantities of drug substance for clinical use.
Source: Quotient Sciences
Univar Adds Four Pharma Ingredient Labs
Univar Solutions, a global commodity and specialty chemicals and ingredients distributor, has added four pharmaceutical ingredient labs at its solution centers in Houston, Texas; Osasco – São Paulo, Brazil; Mexico City, Mexico; and Essen, Germany. The new facilities will provide technical services such as formulation and prototype development, performance and application testing, chemical and product performance analysis, and custom blending for various dosage forms, including oral solid dose, semi-solid, liquid, and topical.
Source: Univar Solutions
Fujifilm Diosynth Breaks Ground on Mfg Expansion for Advanced Therapies & Vaccines
Fujifilm Diosynth Biotechnologies, a biologics CDMO, has broken ground on a $300-million expansion of its biomanufacturing campus in College Station, Texas, to double its advanced therapy and vaccine-manufacturing capacity in the US.
The expansion will add a new cGMP production facility and add approximately 138,000 square feet to the existing 300,000-square-foot campus. The expansion provides space for multiple 500-L and 2,000-L bioreactors and associated purification equipment using single-use, disposable-device technology. The expansion is slated to be operational by 2024.
Andelyn Biosciences Opens Gene-Therapy Mfg Facility
Andelyn Biosciences, a Columbus, Ohio-based CDMO of cell and gene therapies, has opened a new 200,0000-square-foot GMP clinical and commercial gene-therapy manufacturing facility in Columbus, Ohio. The facility can support gene-therapy viral vector production using various modalities, including adherent and suspension platform capacity of up to 8 X 2,000 L.
Andelyn was formed in 2020 from its spin-out from Nationwide Children’s Hospital in Columbus as a for-profit CDMO. In August (August 2022), it opened its Plasmid Production Core, which provides plasmid manufacturing for research-grade production and for investigational new drug-enabling toxicology productions, along with adeno-associated virus vector cloning capabilities. It June 2022, it opened its Plasmid Development Center for research, process development, and analytical development.
Source: Andelyn Biosciences
Scorpion Biological Services Opens Biologics Mfg Facility
Scorpion Biological Services, a San Antonio, Texas-based biologics CDMO, has opened a new biologics manufacturing facility in San Antonio for clinical- and commercial-scale production.
Source: Scorpion Biological Services
Formulation Development/Drug Product Manufacturing
Corium Pharma Solutions Formed as New CDMO
Corium, a Boston-based commercial-stage bio/pharmaceutical company, and Gurnet Point Capital, the owner of Corium, report the acquisition of their manufacturing business and a $100-million equity investment by Webster Equity Partners. The manufacturing business, now named Corium Pharma Solutions, transacted with an investment by Webster for more than $400 million in value, and will operate as a stand-alone CDMO.
As a result, Corium has separated into two companies, Corium Pharma Solutions, a CDMO of drug and consumer products, and Corium, a bio/pharmaceutical company focused on neuroscience therapeutics. Gurnet Point and Webster will jointly own the CDMO, and each will have representatives on the boards for both Corium Pharma Solutions and Corium. Corium Pharma Solutions will remain focused on expanding its CDMO drug and consumer product capabilities while continuing its current partnerships and the manufacture and supply of Corium’s Adlarity (donepezil transdermal system) for treating mild, moderate, or severe dementia of the Alzheimer’s type.
Vetter Commissions New $20-M Warehouse
Vetter, a Ravensburg, Germany-headquartered CDMO of aseptic filling and packaging, has commissioned a new EUR 20-million ($20-million) warehouse for packaging materials. The new storage facility includes 7,700 square meters of logistics space consisting of 1,200 square meters for incoming and outgoing goods and 6,500 square meters of room-temperature storage with the capacity for more than 16,000 pallets and a shelf height of 14 meters. The high-bay warehouse is equipped with automated forklifts and six positions for trucks on a receiving area ramp connected to the transfer area. Four driverless shuttles connect the transfer area with the building’s shelves while four driverless forklifts operate between them.
Aragen To Open New Formulation Mfg Facility in 2023
Aragen Life Sciences, a Hyderabad, India-based CDMO of drug substances and drug products, reports that it plans to operationalize a new 12,000-square-foot formulation manufacturing facility at its site in Hyderabad, India by January 2023. The new plant will have capabilities for a range of dosage forms, including oral solids, liquids, topicals, and films, with technologies for granulation, film coating, spray drying, tableting, with expansion plans in place to add nano milling and hot-melt extrusion capabilities. The new plant will be able to accommodate batch sizes as low as 1,000 units to as high as 100,000 units. When complete and fully operational, the facility will support cGMP manufacturing and Phase I-III clinical supplies of tablets, capsules, liquids, semi-solids and films and offer purpose-built manufacturing suites to support wet granulation, roller compaction, fluid-bed coating, spray drying, micronization, nano-milling, tableting, capsule-filling, film coating, and packaging processes.
Source: Aragen Life Sciences
Recipharm Investing in New Sterile Filling Line & Low-Volume Blow-Fill-Seal Filling
Recipharm, a Stockholm, Sweden-based CDMO of drug substances, drug products and drug-delivery devices, is investing in a new high-speed filling line for pre-filled syringes and cartridges at its facility in Wasserburg, Germany. It is also invested in low-volume blow–fill–seal (BFS) filling capabilities at its facility in Kaysersberg, France.
The new high-speed filling line for pre-filled syringes and cartridges at its facility in Wasserburg is expected to be ready for technical trials by April 2023 with the first GMP batch run in May 2023.
Separately, the company is applying its Lab+ technology to enable a throughput speed of 2,000 doses per hour for BFS projects with smaller volumes at its facility in Kaysersberg, France. The new Lab+ technology supports proof-of-concept, feasibility batches (cGMP & non-cGMP) and clinical Phase I and Phase II batches and can be adapted for a range of different product types and dosage designs. The system can also be charged with formulation using both conventional stainless-steel vessels or single-use charge bags from 200 mL up to 20 L.
Altasciences Expanding Bioanalytical Lab
Altasciences, a Laval, Quebec-based CRO and CDMO of drug products, has begun an expansion of its laboratories in Columbia, Missouri, through the addition of a new 8,000-square-foot space that will mirror the company’s current bioanalytical laboratory in Laval, Québec. The expansion will supplement the service offering already available at Altasciences’ site in Seattle, Washington, to support preclinical and clinical studies conducted in the US. The expansion is expected to be completed in 2023.
BD, Biocorp in Pact for Connectivity, Traceability for Injectable Drugs
BD and Biocorp, an Issoire, France-based medical device and delivery systems manufacturer, have signed an agreement for the use of connected technology to track adherence for self-administered injectable drugs.
The two companies will integrate Biocorp’s Injay technology, a connected solution designed to monitor the use of prefillable syringes in clinical studies or routine care, to BD’s UltraSafe Plus Passive Needle Guard used with prefillable syringes.