Manufacturing Systems, Single-Use

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

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

Integrated Single-Use Sterile and SIP Connector Provide Flexibility

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

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.

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.

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.

ALpHA G Capsule Filter for Single-Use Systems

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

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.

A novel approach to sterile drug product manufacturing that uses a single-use assembly in a multi-product final filling suite with isolator technology offers benefits of efficiency and flexibility.

Studies show diminished cell growth properties associated with some biocontainer or bioreactor films.

Key considerations for implementing single-use components or platforms when moving from research to process development.

Single-use systems and other technologies drive process efficiencies, but there is room for improvement.

Data from BioPlan Associates' 10th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production suggest that the interest in disposable devices has begun to extend to biopharma operations beyond basic single-use bags and connectors.

The first part of CPhI's Annual Expert Industry Report examines ADCs, single-use technology, and regulatory failure.

Novasep's Sius single-use tangential flow filtration skid offers a 100% single-use TFF solution.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

Uwe Gottschalk, vice-president of purification technologies, Sartorius Stedim Biotech, discusses specific challenges in protein purification.

Choosing the right disposable components for your application.

Quality control for disposable-bags

Rita Peters, Editorial Director for Pharmaceutical Technology and BioPharm Inernational talks with Mani Krishnan, director of systems at EMD Millipore live at Interphex 2013 about single-use technology. In this interview they discuss areas of growth in single-use technology as well as reservations that some companies have to switching to single-use systems Krishnan identifies a few technology advances that are overcoming these objections as well as decision-making strategies for facilities considering a switch to a single-use system.