Supplier News: Axplora, Almac, Avantor, CordenPharma & More
The latest from CDMOs, CMOs, and suppliers featuring Axplora, Almac, Avantor, CordenPharma, Biovian, Societal CDMO, Curia, Touchlight, Kindeva, and H&T Presspart.
Chemicals/Chemical API Manufacturing
* Axplora Installs New Pilot Unit for Flow Chemistry
Biologics Manufacturing
* CDMO Biovian Oy Investing $55 M To Expand Mfg for Advanced Therapies
* Curia, Touchlight In Pact for DNA Raw Material
Formulation Development/Drug Product Manufacturing
* Societal CDMO To Expand Controlled Substance Mfg Capacity
* Kindeva, H&T Presspart Partner With the Chiesi Group for Dose-Counter and Dose-Indicator Production Line
General
* Almac Group Opens New Warehouse
* Avantor To Expand Innovation Center
* CordenPharma Launches Technology & Science Advisory Board
Chemicals/Chemical API Manufacturing
Axplora Installs New Pilot Unit for Flow Chemistry
Axplora, formerly Novasep-PharmaZell, a CDMO of small-molecule active pharmaceuticals ingredients (APIs), intermediates, and antibody drug conjugates (ADCs), has installed a new cGMP pilot unit for flow chemistry at its Leverkusen, Germany, site. The equipment allows Axplora to operate at a broad range of temperatures and pressures (-50° C up to 200° C and up to 40 bar), with reactor configurations adapted to the specific requirements of the process.
Source: Axplora
Biologics Manufacturing
CDMO Biovian Oy Investing $55 M To Expand Mfg for Advanced Therapies
Biovian Oy, a Turku, Finland-based CDMO of biologics, is investing more than EUR 50 million ($55 million) to expand its manufacturing facility in Turku, Finland.
The new facility will cover an area of 6,400 square meters for the development, manufacturing, and testing of advanced therapy medicinal products, such as adenoviral and adeno-associated viral (AAV) therapies. It will also feature dedicated Class A to D cleanroom areas for bulk drug substances as well as final drug product manufacture.
Together with Biovian’s existing manufacturing facility, the new premises will increase the total area up to 11,500 square meters. The expansion is expected to be completed in December 2024, with the new facility fully operational by 2025. The investment is expected to create 100 job opportunities in the region in addition to the company’s existing 200 employees.
Source: Biovian
Curia, Touchlight In Pact for DNA Raw Material
Curia, a CDMO of drug substances and drug products, and Touchlight, a provider of a synthetic DNA vector and enzymatic manufacturing process, have entered an agreement which will provide Curia access to Touchlight’s proprietary doggybone DNA (dbDNA) technology for producing plasmid DNA.
The agreement expands Curia’s mRNA manufacturing offerings with an additional differentiated source of DNA raw material. Under the agreement, Touchlight will directly manufacture dbDNA on behalf of Curia’s customers.
Source: Curia
Formulation Development/Drug Product Manufacturing
Societal CDMO To Expand Controlled Substance Mfg Capacity
Societal CDMO, a Gainesville, Georgia-based CDMO of drug products, has announced an expansion of its controlled-substance manufacturing to include psychedelic drug development. The company has received approval from the US Drug Enforcement Administration to add certain Schedule 1 psychedelic compounds to its controlled-substance manufacturing registration, allowing the company to manufacture cGMP clinical supplies.
Source: Societal CDMO
Kindeva, H&T Presspart Partner With the Chiesi Group for Dose-Counter and Dose-Indicator Production Line
Kindeva, a CDMO of drug-delivery services and autoinjectors, and H&T Presspart, a provider of respiratory drug-delivery systems, are partnering with Chiesi Group, a bio/pharmaceutical and healthcare group, for the installation of a production line for dose-counter and dose-indicator devices.
Under the agreement, H&T Presspart will manufacture Kindeva Drug Delivery’s dose counters under license for Chiesi Group for its pressurized metered-dose inhaler portfolio. H&T Presspart will expand the cleanroom facilities at its Marsberg, Germany, site to support the dose-counter production.
The partnership is a continuation of the agreement signed in 2014 between Kindeva Drug Delivery and H&T Presspart to accelerate the growth of Kindeva Drug Delivery’s dose-counter technology.
Source: H&T Presspart
General
Almac Group Opens New Warehouse
Almac Sciences, part of the Almac Group, a Craigavon, UK-based CDMO of active pharmaceutical ingredients (APIs) and drug products, has opened a new GMP warehouse and dispatch hub at its global headquarters in Craigavon, UK.
The new 19,500-square-foot facility consolidates the company’s existing warehouses and supply-chain offices and will provide support to all API manufacturing and laboratory activities, from development to commercialization.
The warehouse has capacity to store 500 pallets of solvent, 800 pallets of 15-25° C materials as well as a walk-in fridge and freezer, all of which are connected to an environmental monitoring system.
This new building forms part of the company’s multi-million-pound manufacturing investment program. The first stage of Almac’s GMP facility expansion was announced in December 2022 with an extension to its current GMP manufacturing facility. The next stage will create manufacturing centers of excellence to support small-molecule API production at up to 200–300 kg scale as well as increased capacity for peptide API production.
Source: Almac Group
Avantor To Expand Innovation Center
Avantor, a distributor and supplier of products and services to the bio/pharmaceutical industry, has announced plans to relocate and expand the company’s Bridgewater, New Jersey, Innovation Center. The expanded center will open in August 2024 at a nearby location in Bridgewater and will double the current size of available lab and pilot space.
Labs in the new center will include upstream and downstream process development, chemistry and material science, analytical and bioanalytical capabilities, viral vector workflows, and electronic materials. It will include larger pilot labs with additional capacity to produce excipients, resins, and bio/pharma reagents. The new site will support all modalities, including monoclonals, cell and gene therapies, and mRNA, and will feature a development and application area, including a viral vector laboratory.
Source: Avantor
CordenPharma Launches Technology & Science Advisory Board
CordenPharma has created a new Technology & Science Advisory board (TSAB) with eight experts from academia and industry, who will provide strategic guidance and scientific expertise to drive forward the company’s continued growth and innovation.
The eight scientific experts come from various disciplines, including chemistry, pharmacology, biotechnology, and regulatory affairs. Their collective expertise will provide insights into emerging trends, technologies, and regulatory advancements across all six CordenPharma technology platforms: (1) peptides; (2) oligonucleotides; (3) lipids and carbohydrates; (4) highly potent products and oncology; (5) injectables; and (6) small molecules.
The eight new board members include experts in the fields of drug development, peptides, oligonucleotides, lipids, injectables, lipid nanoparticles, RNA drug delivery, highly potent oral solid dose forms, flow chemistry, and small molecules. While the board will initially look at science-focused areas, they will also explore bioinformatics, including artificial intelligence and machine learning, in the future. A complete listing of the TSAB may be found here.
Source: CordenPharma
