Abzena, Alcami To Expand; Catalent Adds Drug Product Mfg, Packaging Ops
The latest from CDMOs, CMOs, and suppliers featuring Catalent, Abzena, Alcami, Cytiva, Fujifilm, Almac, Pall, and Hovione.
Chemicals/Chemical API Manufacturing
Almac Awarded $2.7-M R&D Grant for Biocatalysis/Enzyme Research
Almac Sciences, part of the Almac Group, a Craigavon, UK-based CDMO, has secured £2 million ($2.7 million) of support from Invest Northern Ireland (INI), Northern Ireland’s regional economic development agency to accelerate a program of biocatalysis/enzyme research.
Almac Sciences had previously established a biotechnology platform for enzyme chemistry and biology through two successfully completed rounds of R&D investment supported by INI. The new funding, awarded by INI and supported by the European Regional Development Fund, will further develop the program to establish in silico-informed metaGenomic Harvesting Technology (INSIGHT), a platform built from multi-disciplinary research of computational, metagenomics, biology and chemistry methodologies.
The project aims to improve the enzyme0discovery process to allow more robust enzymes to supersede multi-step chemical routes currently used to produce pharmaceutical intermediates and products. The project involves the development of an enzyme identification platform based around Almac’s existing metagenomic data mining using enzyme modelling / engineered lead diversity screening.
Cytiva Installs Modular Biomfg Unit at new Lonza site in China
Cytiva, the new name of GE Healthcare Life Sciences following Danaher’s $21.4-billion acquisition of GE Healthcare Life Sciences in April 2020, has successfully completed the installation of a modular biomanufacturing unit for Lonza at Lonza’s new manufacturing site in Guangzhou Biopark, China.
The 17,000-square-meter site includes 6,500 square meters of lab space and one KUBio, Cytiva’s cGMP modular manufacturing platform, modular facility.
This is Lonza’s first manufacturing site for biologics in China. Lonza will combine Cytiva’s KUBio modular facility and single-use equipment to support its GMP manufacturing integrated with its own platforms and expertise in development, including cell-line construction and process development.
The new 17,000-square-meter mammalian biologics development and manufacturing facility is the product of a three-way agreement between Lonza, Cytiva, and the Guangzhou Development District (GDD), which was signed in 2018, and under which Cytiva and the GDD built and Lonza bought and will operate the facility. The site is to become a strategic base in China for Lonza to provide CDMO services throughout Asia Pacific region.
Fujifilm Secures $76 M for New Biologics Mfg, Innovation Center
Fujifilm and the Massachusetts Center for Advanced Biological Innovation and Manufacturing (CABIM), an industry–academic R&D consortium, have secured $76 million in financing and signed a lease for a new 40,000 square-foot biologics manufacturing and innovation center in Watertown, Massachusetts.
The center will advance research and development in cell and gene therapy, gene editing, immunotherapy, and biotechnology. Fujifilm Diosynth Biotechnologies, a biologics CDMO subsidiary of Fujifilm Corporation, will provide contract process development and manufacturing services as part of its role in the new manufacturing and innovation center.
The facility will have eight cleanrooms, with a configuration that will produce both cell and viral vector products. The site will also offer quality control, lab, office, and convening space to facilitate collaboration between the region’s academia, industries and hospitals. The initial $76- million in funding will contribute to the build of the space, support 40 full-time employees, and will maintain the center’s daily operations. The center is scheduled to begin operations in early 2022.
Previously announced in November 2019, CABIM was established with an equal investment each from Fujifilm, Harvard University, the Massachusetts Institute of Technology, Cytiva (formerly named GE Healthcare Life Sciences), and Alexandria Real Estate Equities. The consortium will work with other collaborators, including Beth Israel Deaconess Medical Center, Boston Children’s Hospital, Brigham and Women’s Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, and MilliporeSigma.
The new center is the latest investment by the Fujifilm. Earlier this month (January 2020), the company announced a capital investment of more than $2 billion to build a large-scale cell culture manufacturing facility in the US. Also, earlier this month (January 2020), it announced a new, separate $40- million viral vector and advanced therapy facility in the greater-Boston area. The new facilities will be operated by Fujifilm Diosynth Biotechnologies.
Source: Fujifilm Corporation
Abzena Plans New Biologics Mfg Facility in the US
Abzena, a contract manufacturer of biologics and antibody drug conjugates, plans to add a biomanufacturing site in the US, the company’s sixth globally.
The new facility will be based in the US and will accommodate Phase III and commercial manufacturing. A phased approach to construction will initially allow four modular suites with each suite having up to two 2,000-L bioreactors, followed by the addition of two further 2,000-L suites. Additionally, the site will be equipped to handle existing and new advances in manufacturing such as continuous manufacturing and perfusion with manufacturing commencing in mid-2022.
Pall To Invest $114 M To Expand Production in the US, Europe
Pall Corporation, a provider of filtration, separation, and purification products and services, has announced it is investing $114 million to add additional production capacity at six existing manufacturing facilities in Europe and the US, as well as a new manufacturing facility in the US.
With these investments, Pall anticipates adding more than 1,100 jobs globally through the end of 2021.
Pall’s new manufacturing facility will be in the US and will focus primarily on single-use technology. Pall’s will expand other manufacturing facilities (Medemblik, Netherlands; Hoegaarden, Belgium; Bad Kreuznach, Germany; Ilfracombe, UK; Newquay, UK; Fajardo, Puerto Rico; and Pensacola, Florida) to produce and distribute single-use technology, media and breathing filters necessary to support the current global pandemic and future industry needs.
Source: Pall Corporation
Formulation Development/Drug-Product Manufacturing
Catalent To Acquire Drug Product Mfg, Packaging Ops from Acorda
Catalent has agreed to acquire the manufacturing and packaging operations of Acorda Therapeutics, an Ardsley, New York-based developer of therapies for neurological disorders.
Under agreement, Catalent will acquire Acorda Therapeutics’ 90,000-square-foot, facility in Chelsea, Massachusetts. The site operates spray drying capacity and will provide Catalent with commercial-scale capacity. The facility will act as a global center of excellence within the Catalent network for spray-dried dispersion and dry-powder encapsulation and packaging. On closing, Acorda Therapeutics’ current workforce at the facility will transition employment to Catalent. Completion of the transaction is subject to customary closing conditions and is expected to occur in the first quarter of 2021.
In addition, Catalent has entered into a long-term supply agreement with Acorda to continue commercial manufacture of Inbrija (levodopa inhalation powder), drug for treating Parkinson’s disease, from the Chelsea facility. Acorda will sell its Inbrija manufacturing operations to Catalent for $80 million.
The Chelsea site will complement and provide downstream capabilities to Catalent’s 180,000- square-foot inhalation development facility in Morrisville, Research Triangle Park, North Carolina, which includes development and manufacturing for metered dose inhalers, nasal sprays, and dry powder inhalers. The Morrisville site offers high-speed commercial-scale manufacturing as well as flexible fill lines for clinical-scale and small batch production.
Alcami Invests $2 M To Expand Oral Solid Development, Mfg
Alcami, a CDMO of active pharmaceutical ingredients (APIs) and drug products, has invested an additional $2 million to expand its oral solid development and manufacturing services in Wilmington, North Carolina.
The investment will add a Gerteis Mini-Pactor roller compactor and low-humidity suites to Alcami’s existing 140,000-square-foot campus in Wilmington, North Carolina. The expansion, which is on track to be completed in the first and second quarter of 2021, respectively, adds dry-granulation capabilities and increased flexibility to support moisture-sensitive processes.
Hovione Launches Screening Service for Spray-Dried Dispersions
Hovione has launched a proprietary screening service for spray dried dispersions. The company says the ASD-HIPROS platform is used to identify optimal and commercially viable amorphous solid dispersions formulation by spray drying (ASDs). ASD-HIPROS (the Hovione Intelligent PROprietary Screening) methodology is able to screen for a combination of polymers, drug loads, surfactants and solvents by using an computational tool followed by producing scale-independent representative samples of the most promising formulations, which are evaluated for performance and stability.
Irisys Gets US Gov’t Contract To Develop New Injectable Formulation
Irisys, a San Diego, California-based CDMO, has been awarded a contract valued at $850,000 by the National Center for Advancing Translational Sciences (NCATS), one of 27 institutes of the National Institutes of Health (NIH), to develop a new injectable formulation of drinabant, a cannabinoid receptor antagonist.
Opiant Pharmaceuticals, an NCATS collaborator, licensed drinabant from Sanofi and is developing it with the goal to treat individuals who have ingested large quantities of THC (the principal active constituent of cannabis) or synthetic cannabinoids, and are diagnosed with acute cannabinoid overdose (ACO). The project’s overall goal is to develop drinabant for parenteral administration to reverse the symptoms of ACO.