Manufacturing

Integrated Single-Use Sterile and SIP Connector Provide Flexibility

Review regulatory requirements and the use of viral-challenge studies in drug development.

Aseptic Valve Range Increases Sterility

TAP Biosystems announced that Gallus BioPharmaceuticals is using its ambr15 micro bioreactor system to optimize process development and clone selection of novel antibody therapeutics and biosimilars.

Grace's ProVance disposable Protein A chromatography column is designed for downstream purification.

ThioBridge linker technology to attach different payloads to a range of antibodies

Biotechnology developer American CryoStem and Rutgers University partner on stem-cell platform technology development.

New identifiers and tracking requirements aim to block illegitimate products.

The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

A review of the past year's trends in biopharmaceutical approvals shows an above average approval rate.

Vetter launches new serialization process to support track-and-trace efforts.

Displays will include new products for anticounterfeiting, labeling, and compliance packaging and new equipment for filling, aggregating, and quality control.

New injection-delivery systems with multiple closure points pose challenges for container closure integrity testing.

For single-use systems, supply chain excellence requires a commitment to problem solving across organization boundaries.

Research uncovers trends and factors affecting the pre-packed disposable chromatography columns market for downstream bioprocessing.

Experts discuss the advances in single-use technology for downstream bioprocessing applications.

Adopting single-use systems has implications for manufacturing execution systems, process data-analytics tools, and scheduling

A novel approach to sterile drug product manufacturing uses a single-use assembly in a multi-product final filling suite with isolator technology.

An environmental study of single-use process technology for biopharmaceutical manufacturing offers a comprehensive examination of environmental impacts across the full process train using lifecycle assessment.

FDA clarifies recommendations for injectable drug products packaged in vials and ampules.

Walker Barrier Systems builds eight mobile clean rooms for the Texas A&M Center for Innovation in Advanced Development and Manufacturing.

Plastic pump chamber is a cost-effective alternative for biopharmaceutical applications.

ASI Life Sciences introduced the DHX Disposable Heat Exchanger and the imPULSE MDS mixing, docking, and shipping system for single-use biopharmaceutical processes.

HHS plan makes progress in ensuring availability of safe vaccines.

Precalibrated instruments deliver accurate readings and withstand rigorous use.

Research uncovers trends and factors affecting the pre-packed disposable chromatography columns market for downstream bioprocessing.

Experts discuss the advances in single-use technology for downstream bioprocessing applications.

Adopting single-use systems has implications for manufacturing execution systems (MES), process data-analytics tools, and scheduling. Enterprise resource planning and MES must be integrated using standards such as ISA-95. Master and electronic batch records must be designed to capture the details of single-use component assembly to enable traceability.

Researchers are using current understanding of the lyophilization process to predict performance on many levels during both process development and manufacturing.