Supplier News: Lonza, Dipharma, Carbogen Amcis & MoreBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Dipharma, Carbogen Amcis, Catalent, Icosagen, Aptar, and BioDuro-Sundia.
Chemicals/Chemical API Manufacturing
* Dipharma Expanding QC Labs, Kilo Lab
* Lonza Completes Expansion of Conjugation Facility
* Icosagen Investing $43-M into R&D & New Production Facility
Formulation Development/Drug Product Manufacturing
* Carbogen Amcis Opens New Sterile Mfg Facility
* Catalent Completes Expansion of Clinical Supply Facility
* Aptar Launches Metal-Free-Nasal-Spray-Pump
* BioDuro-Sundia Completes Lab Expansions in Three R&D Centers
Chemicals/Chemical API Manufacturing
Dipharma Expanding QC Labs, Kilo Lab
Dipharma Francis, a Milan, Italy-based CDMO of active pharmaceutical ingredients (APIs) and intermediates, has completed the second phase of an expansion of its Kalamazoo, Michigan site to provide additional cGMP, quality control laboratory, and warehouse space.
The third phase of the project is ongoing and will expand the company’s current kilo lab by adding a second cGMP line. The new line will be capable of running larger-scale reactions, up to 85 L while also expanding cryogenic reaction and solid-isolation capabilities. The third phase is expected to be completed by the second quarter of 2023.
Lonza Completes Expansion of Conjugation Facility
Lonza has completed an expansion of its bioconjugation facility in Visp, Switzerland. The expansion includes two manufacturing suites and supporting infrastructure, including development and manufacturing capacity for pre-clinical, clinical and commercial supply of bioconjugates and antibody-drug conjugates.
The new suites follow Lonza’s recent investments and asset extensions in Visp in mammalian capacity, microbial development, drug-product development and manufacturing, and high-potency active pharmaceutical ingredient payload-linker manufacturing capacity.
Icosagen Investing $43-M into R&D & New Production Facility
Icosagen, a Tartu, Estonia-based CDMO of biologics, has reached a EUR 18 million ($19.2 million) financing agreement with the European Investment Bank to further strengthen its drug-discovery, development, and production services. The funds are part of Icosagen’s EUR 40 million ($43 million) investment into increasing its contract research and development capabilities as well as into a new cGMP clinical-scale facility.
The construction of the new 1,600-square-meter production plant expands on Icosagen’s existing laboratories in Tartu, Estonia, and will be completed in September 2023. The plant is expected to become operational in 2024.
Formulation Development and Drug Product Manufacturing
Carbogen Amcis Opens New Sterile Mfg Facility
Carbogen Amcis, a CDMO of active pharmaceutical ingredients and drug products, has opened a new 9,500-square meter sterile injectable drug-product manufacturing facility in Saint-Beauzire, France. The new facility increases the company’s product development and manufacturing capacity for liquid and freeze-dried products for preclinical and clinical trials as well as small=scale commercial use. The facility will house 100 employees and add 50 new jobs in 2023.
Source: Carbogen Amcis
Catalent Completes Expansion of Clinical Supply Facility
Catalent has completed a $2.2-million expansion of its clinical supply facility in Singapore. The expansion increases the site’s footprint to 31,000 square feet to create space to install an additional 35 new freezers for ultra-low temperature (ULT) storage.
The investment has also increased the facility’s capabilities to support larger packaging campaigns through the addition of specialized secondary packaging capabilities for ULT products as well as the capacity to handle biopharmaceuticals and advanced modalities, such as mRNA-based vaccines and cell and gene therapies.
Aptar Launches Metal-Free-Nasal-Spray-Pump
Aptar Pharma, a provider of drug-delivery systems and services, has launched APF Futurity, its first metal-free, multidose nasal spray pump developed to deliver nasal saline and other comparable over-the-counter (OTC) formulations.
Designed for recyclability, APF Futurity is Aptar Pharma’s first highly recyclable nasal spray pump. It received a Class AA certification from cyclos-HTP for recycling streams in Europe.
Source: Aptar Pharma
BioDuro-Sundia Completes Lab Expansions in Three R&D Centers
BioDuro-Sundia, a Shanghai-based contract research, development and manufacturing organization, has recently completed expansions within three different R&D centers in China (Shanghai Waigaoqiao, Shanghai Zhangjiang, and Beijing) to add more than 100,000 square feet of laboratory space.
The expansion of the discovery biology department features enlarged HCS capability and the development of more than 180 new biochemical and cell assays. The pharmacology department added 15+ new disease models. The oncology department added 40+ CDX models and increased IVIS based real-time metastasis and drug-distribution analyses. The biologics department initiated a VHH library based on alpaca immunity, ADC, high-throughput antibody expression, affinity detection and physical and chemical characterization services. Lastly, the DMPK department added in-vivo and in-vitro detection services.