Manufacturing

The agency is releasing six new draft guidances to provide a regulatory framework for handling gene therapies.

Catalent Biologics will adopt Berkeley Lights’ Beacon optofluidic platform for its cell-line development workflow.

Findings from a survey show that some companies have not yet taken the necessary steps to ensure the continuity of medicine supply in the European Union after the United Kingdom’s departure.

Flexibility and process intensification are advantages of continuous biopharmaceutical manufacturing, but some challenges remain.

Report predicts PAT, NIRS, continuous bioprocessing, and a ‘technological arms race’ could improve biopharma manufacturing efficiencies.

The acquisition of Flex Concepts adds custom, single-use products to Entegris’ single-use bag product line.

Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.

Modern technologies, including Industry 4.0 and the Industrial Internet of Things, offer opportunities to increase biopharmaceutical manufacturing efficiency.

Increasing demand for biologics is driving the need for innovation in bioprocessing.

Late-stage and commercial biomanufacturing pose a challenge to cell-culture processing.

Biosimilars and biobetters face developmental challenges to achieving commercialization.

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

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.

Silicone is one of the polymeric materials that can be used for single-use components and assemblies in biopharmaceutical manufacturing.

Understanding differences in bioreactor lifecycle, design space, and product platforms is important for selecting a bioreactor type.

Robust materials management, supplier quality management, quality control, and business continuity planning are essential to ensure continuous supply of single-use bags.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

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

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.