Supplier News: Hovione, Lonza, Arranta Bio & More
The latest from CDMOs, CMOs, and suppliers featuring Hovione, Lonza, Arranta Bio, Thermo Fisher Scientific, WuXi Advanced Therapies, Stevanato Group, UPS Healthcare, Lykan Bioscience, List Biotherapeutics, and the Center for Breakthrough Medicines.
Lonza Expanding Microbial Development Labs
Lonza has announced an investment in additional microbial development capacity at its facility in Visp, Switzerland. The expansion is slated to be operational by the end of 2021 and will be aligned with available manufacturing capacity, including support of new mid-scale assets, which are slated to come on line in 2022.
New development capacity will consolidate the microbial footprint at the Visp site and add new high throughput equipment and automation processes. The automation upgrades include three liquid-handling workstations and other equipment for upstream and downstream process development as well analytical method development. The expansion includes the installation of a dedicated pilot suite with a 50-L fermenter and corresponding downstream equipment, which will generate non-GMP product suitable for formulation and toxicology studies.
WuXi AppTec Opens Advanced Therapies Testing Facility
WuXi Advanced Therapies (WuXi ATU), a subsidiary of WuXi AppTec, has opened a new advanced therapies testing facility in Philadelphia, Pennsylvania.
The new facility includes 140,000 square feet of laboratories and triples the company’s testing capacity. The new facility is an expansion of WuXi ATU’s existing campus, which opened in 2020.
Source: WuXi Advanced Therapies
Arranta Bio Divests Clinical Mfg Facility to Inceptor Bio
Arranta Bio, a CDMO focused on live biotherapeutic products and the human microbiome, has completed the sale of its process development and clinical manufacturing facility in Gainesville, Florida, to Inceptor Bio, a Raleigh, North Carolina-based bio/pharmaceutical company.
Inceptor gained the 29,000-square-foot facility and a core operating team of over 160 employees to establish cell-therapy processes and clinical supply for Inceptor Bio’s oncology therapy candidates.
Additionally, Arranta is progressing the establishment of end-to-end mRNA capabilities and expects to begin laboratory-scale operations in January (January 2022) and to have starting materials, mRNA, lipid nanoparticle formulation, and a robotic sterile fill line installed in its facility in Watertown, Massachusetts by the end of the second quarter of 2022.
Arranta recently received permitting approval to progress the first build-out phase of laboratory and GMP capacity at a second commercial-ready site in Boxborough, Massachusetts, which is slated to be completed by mid-2022.
Source: Arranta Bio
Lykan To Expand Cell-Therapy Mfg Capacity
Lykan Bioscience, a Hopkinton, Massachusetts-based CDMO of cell-based therapies, has announced plans to expand its cell-therapy manufacturing facility in Hopkinton.
Seven ISO 7 cGMP suites will be added to the existing facility with capabilities for both autologous and allogeneic production bringing the total number of clinical and commercial cGMP manufacturing suites to 15. The expansion is expected to be commissioned and operational for partner programs by the fourth quarter of 2022.
The expansion also includes a 1,700-square-foot addition within the manufacturing facility for process and analytical development capabilities. This laboratory expansion is expected to be commissioned and operational for customer projects by the fourth quarter of 2021.
Source: Lykan Bioscience
List Biotherapeutics Invests $125 M in Microbiome Mfg Facility
List Biotherapeutics, whose parent company is South Korea-based Genome & Company, has invested more than $125 million to establish a new 110,000-square-foot CMO facility in Fishers, Indiana.
The company plans to hire 210 employees in Fishers in the areas of biologics manufacturing and quality and regulatory compliance after commissioning the facility by the end of 2023. The expansion includes new lab and office space.
The Fishers Life Science & Innovation Park, where the facility is located, was established in August 2021 and has seen more than $200 million in investments from life-science firms Stevanato Group and INCOG Pharma, with eight acres remaining for development.
Genome & Company recently completed an investment into List Labs, List Biotherapeutics’ sister company, and became a majority shareholder.
Source: List Biotherapeutics
CBM To Expand Cell-, Gene-Therapy Mfg
The Center for Breakthrough Medicines (CBM), an advanced therapy CDMO, has entered into exclusive negotiations with SK Inc., a Seoul, South Korea-based holding company, to secure funding for its CDMO business for end-to-end cell- and gene-therapy contract development and manufacturing.
Established in 2019, CBM offers preclinical through commercial manufacturing, including process development, plasmid DNA, viral-vector manufacturing, cell banking, cell processing, and testing and analytical development.
CBM says it will use the net proceeds of the undisclosed financing to support operations, research, build-out of labs and GMP suites, automation and infrastructure. The financing is expected to close in December 2021.
CBM will occupy nearly 700,000 square feet at The Discovery Labs campus located in King of Prussia, Pennsylvania.
Formulation Development/Drug-Product Manufacturing
Hovione Investing $170 M To Expand HPAPIs, Spray Drying
Hovione has announced plans to invest $170 million to expand its industrial facilities in Portugal, Ireland, and New Jersey.
In the US, Hovione will add a 2900-m2 building next to its current facility in East Windsor, New Jersey, for additional commercial spray-drying capacity, scheduled to be on line by 2023.
In Ireland, Hovione’s Cork site will be upgraded to enable the production of highly potent active pharmaceutical ingredients (HPAPI) and to facilitate onboarding of drug-substance manufacturing projects of all sizes. The site will also receive a new commercial-size spray dryer
In Portugal, Hovione says it is ready to start operations of its most recent facility with an increase in chemical synthesis capacity for HPAPIs. The building is also prepared to receive a new commercial spray dryer to respond to future needs.
The expansion will add more than 300 new jobs globally.
Bayer, Syntegon in Continuous Mfg Pact
Bayer and Syntegon, a process and packaging equipment and technology provider, have entered into a strategic partnership for the development of new continuous manufacturing processes for oral solid dosage forms.
The cooperation is based on the Syntegon’s Xelum platform, which uses fluid-bed granulation, developed by Syntegon’s subsidiary, Hüttlin.
Stevanato Group Expands Corporate HQ, Mfg
Stevanato Group, a provider of drug-containment, drug-delivery and diagnostic products and services, has expanded its corporate headquarters with the construction of a new facility in Piombino Dese, Italy.
The new 6,750-square-meter facility will support the optimization of Stevanato Group’s industrial footprint, with about 2,500 square meters dedicated to increasing the production of high-value products. In addition to hosting offices, the Italian analytical services site, and R&D space, it will also include new glass syringe forming lines for advancing the production of EZ-Fill syringes and vials.
Construction of the new building began in September 2021. The company expects to install and validate new lines in the second quarter of 2022, and for industrial production to begin between late second quarter and early third quarter of 2022.
Source: Stevanato Group
Thermo Fisher Selects Location for Pipette-Tip Mfg Facility
Thermo Fisher Scientific has selected Mebane, North Carolina as the site for its new pipette-tip manufacturing facility.
The site is part of a recently announced co-investment with the US government under a $192.5- million contract with the US Department of Health and Human Services to ensure domestic supply of laboratory pipette tips.
Thermo Fisher currently employs approximately 4,000 colleagues across seven sites in North Carolina, including a center of excellence for laboratory equipment in Asheville, three life sciences and chemical manufacturing sites in Durham, pharmaceutical manufacturing sites in Greenville and High Point, and a Raleigh distribution center. The Mebane site is expected to create 150-200 new jobs in manufacturing, engineering and business operations.
Source: Thermo Fisher Scientific
UPS Healthcare Opens New Cold-Chain, Packaging Center
UPS Healthcare has opened a new cold-chain and packaging center in Louisville, Kentucky,
The facility is the company’s first US-based logistics facility to offer reusable cold-chain packaging options.
Source: UPS Healthcare