Facility Design and Engineering

Lonza plans to invest approximately CHF 850 million (US$936 million) to build new state-of-the-art mammalian manufacturing facilities at its Visp, Switzerland, and Portsmouth, NH, sites.

Catalent has acquired Promethera Biosciences’ cell therapy manufacturing subsidiary, which includes a 32,400 ft2 facility in Gosselies, Belgium.

Moderna will double the space at its Moderna Technology Center in Norwood, MA, to transform it from a production and lab space into an industrial technology center.

AMRI will increase R&D and manufacturing capabilities for orphan and rare disease products.

Under the terms of the contract, Meissner will expand its Camarillo, Calif., manufacturing site by adding additional cleanroom manufacturing space, executing advanced inventory management systems, and adding support areas to supplement capacity.

ADMA will now have the ability to produce Bivigam at an expanded capacity with the same manufacturing scale, while using the same equipment, release testing assays, disposables, and labor force.

AkesoBio’s expanded manufacturing capacity, enabled by the addition of another Cytiva FlexFactory platform, will be used to meet current and future market needs in China as well as worldwide.

In addition to the traditional FOYA category awards, ISPE recognized two facilities for operational agility during the COVID-19 pandemic.

Lonza’s new complex will occupy 2000 m2 of the facility with six levels of manufacturing space and will provide room for future small-molecule technologies expansion.

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

The new facility, which will be Evotec’s first in Europe, will aim to offer capacity, flexibility, and quality for biotherapeutic development and manufacturing while utilizing technology that employs small, automated, highly intensified, and continuous bioprocessing operations inside autonomous cleanrooms.

CordenPharma’s expansion will include the addition of new production lines which will be merged into the lipid manufacturing process in April 2021.

Sartorius has expanded in the United Kingdom with the relocation to a new facility in Havant, Hampshire, for downstream processing equipment.

The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

The new Abzena facility will initially include four modular suites with up to two 2000-L bioreactors, followed by the addition of two more 2000 L suites.

Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.

In collaboration with the Singapore Economic Development Board, the new site will supply the Asian region and will include multiple fully digitalized modules for the production of three to four vaccines simultaneously

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

The transaction is set to close during the first half of 2021 and is expected to enhance drug substance and drug product capabilities for WuXi.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.

The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.

The expansion will allow Ashland to focus on clinical study projects and commercialization activities.

Currently, the facility manufactures products for oral diabetes treatment and will be expanded to increase capacity for these products.

The site will house development and GMP production capacities for cell and gene therapies, next-generation vaccines, and biopharmaceuticals, to support clients from early clinical trials through commercialization.

The expansion, to be completed in April 2021 aims to increase the CDMO’s viral-vector production capacity in Spain.