Manufacturing

This article highlights 15 years of changes in biopharmaceutical manufacturing.

The author reviews current approaches to sterile containment and compares several sealed transfer and barrier techniques, including isolators, restricted access barrier systems, and split butterfly valve technology.

EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

Traditional barriers between upstream and downstream bioprocessing are slowly starting to break down, as biopharma embraces more advanced analytics and process control.

Vendors are offering template-based models and direct data-filing services to help smaller companies meet imminent deadlines.

Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Vac-U-Max received “atmosphères explosibles” or equipment for potentially explosive atmospheres (ATEX) approval for three product ranges of compressed-air-powered vacuums.

The company’s next-generation ultraperformance liquid chromatography platform is designed to meet the evolving laboratory requirements for chromatographic performance.

Minakem’s facility in Belgium enhances capacity to scale production of highly potent ingredients for small to full GMP batches.

The company has completed the first phase of expansion at its headquarters in Freiburg, Germany, in anticipation of increasing demand as cell and gene therapies approach commercialization.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Automated robotic arms manipulate nested trays and containers inside closed aseptic filling systems.

The acquisition expands Micromeritics’ portfolio of products and solutions.

Intelligent manufacturing and environmental policies are key trends at P-MEC 2018.

Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.

The new industry-led Medicines Manufacturing Innovation Center (MMIC) will offer a unique service to develop and implement novel manufacturing techniques.

WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.

The India Expo Mart in Delhi will host CPhI and P-MEC India with expected attendance of 50,000.

Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.

ABB’s modeling software, Shop Floor Integration V2.0, allows engineers to validate the connection of existing pharmaceutical manufacturing equipment with Werum’s PAS-X manufacturing execution system in a simulation prior to running it live.

The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.

Flow imaging microscopy can be used to identify particulates and their sources.