Alcami Sells Early-Stage API Facility; Covance Launches Cell/Gene Therapy ServicesBy
The latest news from CDMOs, CMOs, and suppliers featuring news from Alcami, Covance, WuXi Advanced Therapies, Comar, and Argonaut.
Chemicals/Chemical API Manufacturing
Alcami Sells API Mfg Facility in Netherlands to MercachemSyncom
Alcami, CDMO of active pharmaceutical ingredients (APIs) and drug products, has sold its preclinical and early-stage API facility in Weert, Netherlands to MercachemSyncom, a mid-sized European integrated drug-discovery and development contract research organization. Terms were not disclosed.
The sale follows other recent strategic steps Alcami has taken to enhance the productivity of its network. In December 2019, the company announced a 6,000-square-foot expansion at its facility in Charleston, South Carolina, which will augment the capacity of Alcami’s sterile drug- product development and manufacturing operations. The $17-million investment is expected to create 30 new jobs in Charleston and be completed in 2021.
WuXi Advanced Therapies Launches AAV Vector Production Platform Services
WuXi Advanced Therapies, part of WuXi AppTec and CDMO for advanced therapies, has expanded its service capabilities by offering an adeno-associated virus (AAV) Vector Suspension Platform for cell and gene therapy development, manufacturing and release.
The service will provide an integrated platform for AAV vector production that includes: in-stock raw materials with established batch records; regulatory and technical expertise; process and analytical development; full in-process and release testing; quality control and quality assurance oversight; and facilities with capacity for scalability that ranges up to 1,000 L.
Source: WuXi Advanced Therapies
Covance Launches Cell and Gene Therapy Development Services
Covance, a contract research organization and part of LabCorp, has introduced a suite of cell and gene therapy development solutions.
Covance provides services for preclinical, clinical and post-approval phases of development, which includes biomarker and companion diagnostic development, study management, regulatory, and commercialization support capabilities.
Formulation Development/Drug-Product Manufacturing
Argonaut Launches Aseptic Vial-Filling Services
Argonaut Manufacturing Services, a CDMO of development and manufacturing services, has launched aseptic vial-filling services. With the announcement of the launch on January 7, 2020, Argonaut will begin serving clinical-phase customers in the first quarter of 2020.
Argonaut says the services were designed to maximize yield of biologics and other high-value drug substances.
Source: Argonaut Manufacturing Services
Phillips-Medisize Expands Clinical Mfg for Drug-Delivery Devices
Phillips-Medisize, a provider of drug-delivery devices, is expanding its current global innovation and development site in Struer, Denmark with a dedicated manufacturing development and clinical build unit, which is scheduled to open in the second quarter of 2020.
The facility will be equipped to serve clients with a setup for cleanroom assembly and molding (e.g. for clinical trials). Approximately 500 square meters of floor space from the existing 8,400 square meters building will be repurposed for the cleanroom. The facility is designed to support late-stage development of medium- and high-volume products and processes, under GMP and using new equipment.
Comar To Expand Capacity in Dropper Assembly Product Line
Comar, a plastic packaging, device and component supplier, is expanding capacity for its dropper assembly product line.
The company says the expansion includes additional injection molding machines, glass pipette forming machines, and additional molds and assembly equipment. Many of these investments will be completed in the first quarter of 2020, and by 2021, the company says it expects full implementation by increasing capacity by up to 60%.
In addition to its in-house capacity expansion, Comar says it is working with component suppliers to ensure right-sized capacity and to support more collaborative supply chain to shorten lead times.