Olon, Cambrex, Lonza, IDT Biologika, Catalent, and LSNE ExpandBy
The latest news from CDMOs, CMOs, and suppliers featuring news from Olon, Cambrex, Catalent, Lonza, IDT Biologika, and LSNE.
Chemicals/Chemical API Manufacturing
Olon Expands Microbial GMP Manufacturing Site in Italy
Olon, an active pharmaceutical ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, has started construction of a new good manufacturing practice (GMP) facility at its microbial CDMO facility in Capua, Italy.
The construction of the new GMP facility is associated with a long-term strategic partnership with a large pharmaceutical company. The engineering project is designed to support the manufacture of multiple products up to commercial scale.
Olon has 11 manufacturing facilities spread over Europe (Italy and Spain), US (Concord, Ohio), and India (Mahad) as well as branch offices in Hamburg, Germany; Florham Park, New Jersey; and Shanghai, China.
Cambrex to Expand Edinburgh Solid-Form Screening Facility
Cambrex, a contract manufacturer of small-molecule active pharmaceutical ingredients and drug products, is expanding its solid-form screening and crystallization process-development facility in Edinburgh, Scotland, doubling the facility’s footprint to 15,000 square feet.
The Edinburgh site currently has 50 employees, and the expansion will add additional laboratory space to enable recruitment of up to 40 more scientists with the potential for further growth, according to Cambrex.
Construction is expected to begin in late August 2019 with a target completion date of the end of 2019. <p?
Cambrex’ Edinburgh site provides solid-form development services for drug substances and drug products. These services include solid-state investigations such as salt, co-crystal and polymorph screening, in addition to crystallization process-development and GMP analytical services.
The expanded laboratory space will allow for the installation of additional instruments and reactors for larger-scale crystallization studies and solid-form screening capabilities. The company says that plans are in place for the installation of new ultra-performance liquid chromatography and gas chromatography instruments, as well as additional process analytical technology tools.
The Edinburgh site became part of Cambrex’s global network of development and manufacturing facilities after its $252-million acquisition of Avista Pharma Solutions earlier this year (January 2019).
Lonza, Vineti Partner in Cell and Gene Therapies
Lonza and Vineti, a company offering a commercial, configurable cloud-based platform for patient access to cell and gene therapies, have formed a partnership in which they will be preferred partners, respectively for patient-tissue tracking and contract development and manufacturing services in cell and gene therapies .
The partnership comprises an integrated offering, including logistics, scheduling, distribution, chain of condition, chain of custody, chain of identity, and Lonza’s proprietary solutions such as MODA-ES. MODA-ES, an electronic batch-record execution platform that offers specific functionalities for cell and gene therapies manufacturing.
The Vineti supply chain orchestration (SCO) platform is an independent solution to serve commercial cell and gene-therapy products to keep a real-time end-to-end connection between Lonza and the points of care that prescribe their therapies.
The companies say that the Lonza–Vineti solution will provide biopharmaceutical developers with a pre-integrated SCO and manufacturing system that will offer digital, optimized end-to-end traceability and control.
Catalent Closes Deal to Lease Two Novavax’s Development and Mfg Sites
Catalent and Novavax, a biopharmaceutical company developing vaccines, have closed their previously announced arrangement under which Catalent’s Biologics’ Paragon Gene Therapy unit, which provides viral vector development and manufacturing partner will assume the leases to two Novavax product- development and manufacturing facilities. The companies had announced the deal in June 2019.
Paragon has now purchased Novavax manufacturing equipment and related assets for approximately $18 million, assumed the property leases to two Novavax product-development and manufacturing facilities and hired over 100 Novavax’s manufacturing and quality employees.
Novavax entered into a services arrangement with Paragon under which Paragon will provide ongoing process and analytical development and has the opportunity to manufacture GMP materials for clinical trial supplies for Novavax’s NanoFlu, quadrivalent influenza nanoparticle vaccine, and ResVax, a fusion protein recombinant nanoparticle vaccine for respiratory syncytial virus, among other projects.
Catalent says projected cost savings from the personnel and lease transfers and the cash infusion from the asset purchases will allow Novavax to conduct a Phase III clinical trial for NanoFlu that is scheduled to be initiated in the third quarter of 2019.
IDT Biologika Opens New Vaccine-Production Facility
IDT Biologika, a contract manufacturer of vaccines and biopharmaceuticals, has opened a new multifunctional production facility in Dessau-Rosslau, Germany to provide the company with additional capacity.
IDT laid the foundation stone for the new building in 2018.
Source: IDT Biologika
Formulation Development/Drug Product Manufacturing
LSNE Expands Controlled-Temperature Storage Capacity
Lyophilization Services of New England (LSNE), a contract development and manufacturing organization, has announced the expansion of GMP storage capabilities at its facility in Bedford, New Hampshire.
The new space is intended to accommodate clients’ increased needs for validated storage capacity. The expansion provides for short and long-term cGMP storage of controlled-room temperature, refrigerated, and frozen (-20 Celsius degrees and -80 Celsius degrees) temperature-sensitive products.
LSNE says this capability compliments the adjacent quality-control laboratory to support LSNE’s growing analytical and microbiology testing services and integrated storage options.
In addition to the validated storage capabilities, the expansion added larger ICH stability chambers for all standard storage conditions, including -20 Celsius degrees, 2-8 Celsius degrees, 25 Celsius degrees/ 60% relative humidity (RH), 30 Celsius degrees /65% RH, and 40 Celsius degrees /75% RH.