Facility Design and Engineering

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

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.

GE Healthcare Life Sciences’ new facility for cell and gene processing supplies will be open in 2022.

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.

The new site can manufacture oligonucleotide APIs at large scale.

Predictive and prescriptive maintenance improve pharmaceutical manufacturing equipment effectiveness.

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

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

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

Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.

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

The new site will be used for the storage of contingency stocks of European Pharmacopoeia reference standards for distribution worldwide in case of major incidents at its main site in Strasbourg, France.

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 goal of Design for Reliability (DfR) is to eliminate defects at the design stage; PharmTech interviews Jacobs about DfR for pharma equipment.

Through a partnership with the Sobti family, the CDMO will expand is injectable dosage form capabilities.

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.

GE Healthcare Life Sciences will supply Akeso Pharmaceuticals with the FlexFactory platform to accelerate production of antibody drugs in the Guangzhou region.