Lonza, BSP Pharmaceuticals Expand; Aptar Acquires Cohero HealthBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, BSP Pharmaceuticals, Aptar, Minaris Regenerative Medicine, and PerkinElmer.
Chemicals/Chemical API Manufacturing
Lonza Opens New ADC Drug-Linker Mfg Suite
Lonza has opened the first of two manufacturing suites for antibody-drug conjugate (ADC) drug-linker (payload) manufacturing at its site in Visp, Switzerland
This first manufacturing suite handles compounds with occupational exposure levels down to 1ng/m3 and is dedicated to the manufacturing platform for ADC drug linkers. The suite has been in operation since March of this year (2020). The company says a second suite will become available in early 2021 for similar high-potency active pharmaceutical ingredient and payload development and manufacturing programs.
Minaris To Invest $64.5 M To Expand Mfg for Cell, Gene Therapies
Minaris Regenerative Medicine, a CDMO of cell and gene therapies, plans to invest $64.5 million to expand its facilities in Europe and Asia. Minaris Regenerative Medicine is wholly owned by Showa Denko Materials, which recently changed its name from Hitachi Chemical. The regenerative medicines business of Hitachi Chemical adopted the name, Minaris Regenerative Medicine, for its CDMO business.
In Europe, a new facility will be built in the proximity of it existing site in Ottobrunn, Germany near Munich with an investment of $40.7 million. The facility will be dedicated to clinical and commercial manufacturing as well as development services for cell and gene therapies. With a total of 6,650 square meters, the facility will more than double Minaris’ existing capacity in Europe by providing additional cleanrooms, quality control laboratories, warehousing, cryo-storage, and office space. The new facility is expected to be operational in early 2023.
In Asia, a new facility, with an investment of $23.8 million, will be established adjacent to the company’s existing facility in Yokohama, Japan. An additional 4,000 square meters will double capacity for commercial manufacturing of regenerative medicines. The new facility is scheduled to start operations in October 2022.
The European and Asian expansions complement the opening of a new commercial facility in Allendale, New Jersey announced earlier this year (January 2020).
Source: Minaris Regenerative Medicine
Aptar Acquires Digital Health Company Cohero Health
Aptar, a provider of consumer dispensing, active packaging, and drug-delivery products and services, has acquired all of the operating assets and the proprietary portfolio of Cohero Health, a digital health company for respiratory disease management.
With this transaction, Aptar Pharma acquires Cohero Health’s turnkey digital health platform and device assets. Founded in 2013, New York-based Cohero Health develops digital tools and technologies to improve respiratory care and optimize medication utilization.
BSP Pharmaceuticals Issues Update on Expansions
BSP Pharmaceuticals, a Latina Scalo, Italy-based CDMO, has announced recent investments and expansions with the addition of two aseptic filling lines, an expansion of drug-substance and drug-product manufacturing for high-potent and cytotoxic compounds, and new capacity for non-cytotoxic products.
Following two separate inspections performed in February 2020 and September 2020, the Italian Medicines Agency (AIFA) has authorized two new aseptic filling lines. The two additional aseptic filling lines for liquid and lyophilized vials will increase capacity to a total of 22.0 million units per year.
Separately, in June 2020, the company approved capital investments to expand its existing capacity for drug-substance and drug-product manufacturing for high-potent and cytotoxic compounds. The investment will consist of an expansion of approximately 30,000 square feet with the construction of new areas where an additional filling line for liquid/lyo vials and two additional conjugation areas will be installed.
The new filling ling is planned to be in operational by the second half of 2021 and will add capacity to produce up to 6.5 million vials annually. The two conjugation suites will be available starting from the end of 2021, and each one will add capacity for more than 420 kg monoclonal antibody (mAb) per annum. This expansion will more than triple current capacity for drug-substance manufacturing to 1,254 Kg mAb and will offer the possibility to scale up batch sizes.
In another development, the company reported that its capacity expansion for non-cytotoxic products, which was started in 2018, will be fully completed by 2023. The project includes the installation of six filling lines for liquid and lyophilized injectable products plus the implementation of ancillary services, including dedicated utilities, additional warehousing, and new development laboratories. The first two lines will be in operational starting from mid-2021, and the other four will be released within the following two years. Starting capacity will be 12.7 million vials per annum and will be increased to 44.5 million by the end of 2023, when the full project will be completed.
The new facility will operate full contained technology and will be available for small- and large-molecules drug-product manufacturing of immuno-oncology drugs (mAbs, checkpoint inhibitors, synthetic vaccines), immunotherapy drugs, as well as other products.
Source: BSP Pharmaceuticals (aseptic filling lines), BSP Pharmaceuticals (high potent and cytotoxic compounds), and BSP Pharmaceuticals (non-cytotoxic products)
PerkinElmer To Acquire Horizon Discovery for $383 M
PerkinElmer has agreed to acquire Horizon Discovery Group, a Cambridge, UK-headquartered gene-editing technology company, for approximately $383 million.
Horizon is a provider of CRISPR and RNAi reagents, cell models, cell engineering, and base editing offerings to help scientists understand gene function, genetic disease drivers, and biotherapeutics delivery. Horizon has approximately 400 employees across multiple countries, including the UK, the US, and Japan. It reported 2019 revenues from continuing operations of $75.5 million.
With this investment, PerkinElmer will expand its portfolio of automated life-sciences discovery and applied genomics solutions to include gene-editing and gene-modulation tools. It will also provide tools for exploring cell engineering and customized cell lines for relevant biological models.
The transaction is expected to close in the first quarter of 2021, subject to customary closing conditions.