Manufacturing

The European Pharmacopoeia Commission re-evaluates its policy on the development of monographs for finished drug products.

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Suppliers see challenges to the adoption of single-use technologies for downstream processing as opportunities.

New formulations and expanded vaccine production are encouraged.

Progress is being made in the development of harmonized best practices for single-use systems.

New approaches to vaccine production are targeting rapid supply for pandemic situations and broadly effective therapeutic treatments.

Clinical Syringe Packages Increase Productivity

New human and plant-based expressions systems can enable faster product development and improve quality at potentially lower costs.

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.