Facility Design and Engineering

ISPE’s Facility of the Year Awards for 2020 go to bio/pharma companies in eight award categories, including two winners in the new Social Impact category.

As politicians focus on drug cost reduction, biopharmaceutical companies in the US are moving to states with lower taxes and relocating some facilities that had been offshore.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

Through the agreement, Bora will obtain ownership of the entire Mississauga site, including all facilities, under the proper regulatory clearances.

The new center expands the company’s R&D capabilities and will help it advance its portfolio of rare disease gene therapy programs.

Single-use and modular systems will meet demand for rapid implementation at different scales.

The expansion gives the company diversified capacity running cell production lines featuring Sartorius-brand 2000-L disposable bioreactors and now GE-brand 2000-L single-use bioreactors.

The 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.

CMOs and CDMOs expanded their services and facilities in 2019 and early 2020.

The new facility includes six classified environment rooms with space to expand.

The new 1800-m2 building houses more than 50 employees and features non-GMP laboratory space and a GMP analytical laboratory.

The new facility, to be operated under the newly formed CDMO, The Center for Breakthrough Medicines, will be located in King of Prussia, PA, and will increase manufacturing capacity for cell and gene therapies.

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

As the facility becomes fully operational, the company believes the potential risk of a shortage of the product due to increasing demand will be significantly reduced.

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

The facility is now equipped to handle commercial manufacturing of a sterile injectable product in a pre-filled syringe presentation.

The formation of the new gene therapy company stems from the progress and success of Nationwide Children’s Hospital’s clinical manufacturing and gene therapy work.

The Ireland-based company can now offer complete elemental impurities testing services.

By consolidating legacy buildings, Colorcon enhances environmental and production efficiencies at West Point, PA facility.

The expansion plans to build upon the company’s high potent drug manufacturing and development capabilities, including both clinical and commercial supply.

The expansion will enhance the company’s specialty drug product capabilities.

The new technical service center at the Memphis International Airport will service inbound and outbound traffic for the company’s CSafe RKN and CSafe RAP active container systems.

The new Technology Excellence Center, located in Boston, MA, will further the company’s presence in the United States biopharma drug development landscape.

The new 50,000-square-foot facility will create 200 new jobs and accelerate commercialization of gene and cell therapies.

Through the program, the company will introduce seven new manufacturing sites that will be completed and operational by the end of 2020.

Rentshler Biopharma has begun its expansion project in the United States by putting a single-use bioreactor into operation at the Milford facility in Massachusetts.

The new service will assist pharmaceutical companies with quality control and analytical requirements.

The new center will handle the delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.

The plant in Singen, Germany will be used for formulation, filling, and packaging of Takeda’s vaccine candidate.

The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.