Manufacturing Systems, Single-Use

Suppliers indicate prices for single-use equipment are likely to increase.

The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

Manufacturers are producing new drugs and vaccines and clinical supplies faster and more efficiently through the development of standards and common practices for single-use technology systems.

Products on display include the newest addition to the Mobius line of single-use bioreactors; Cellvento CHO cell culture media for optimized production of specific cell lines; and new high-volume AFS water purification systems.

The use of disposables requires careful consideration and planning.

Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.

The single-use clarification system eliminates centrigues; harvesting can be performed in one step; and process robustness and predictability are ensured.

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.

Whether outsourcing or developing cell therapies in-house, success demands a focus on quality, cost of goods, and sustainability from the start.

Single-use components aid efficiency in automated personalized therapy manufacturing.

Dual sourcing is one of many possible solutions to securing the supply chain.

Application of single-use technology in a parenteral facility for syringe filling.

Consider these best practices when deciding to implement single-use components.

After realizing benefits from the adoption of a single-use filling line for one specific product, Patheon took the leap and installed a single-use filling line in a new facility.

There is no harmonized guidance on pre-use integrity testing of sterilizing filters, prompting discussion among users as to whether such testing is necessary.

Recycling is becoming a viable option for disposal of single-use systems.

This column will address some of the questions on how single use systems are sterilized by gamma irradiation and what documentation may be requested by regulators.

Jerold Martin, senior vice president global technical affairs, at Pall Life Sciences, explains the importance and impact of single-use systems in sterile environments.

June and July saw three major US conferences on implementing single-use technologies: the IBC Single-use Applications meeting, the PDA Single-use Workshop and the Bio-Process Systems Alliance (BPSA) International Single-use Summit (ISUS). Jerold Martin highlights some of the key topics discussed at these meetings.

Recently, there have been many innovations in the latest techniques and technologies in API purification. In particular, the trend to single-use systems has had a significant impact on processes.

Strategies to minimise particle levels in the finished product when using single-use technologies downstream of final filters.

The authors compare three systems of single-screw extrusion using binary formulations for their suitability for producing pellets of various formulations and under various spheronization conditions.

Regions around the world are starting to follow the US trend in disposables and are working to solve common challenges.

Results from our annual survey. This article contains online bonus material and is part of a special issue on Bioprocessing and Sterile Manufacturing.

Over the past 10 years or so, we've seen single-use technologies explode from production-scale filter capsules, tubing and simple biocontainers to encompass sterile connectors, membrane chromatography adsorbers, bioreactors, mixers, and integrated platform systems with increasing levels of sensors and automated controls.

The willingness of the industry to use single-use bioreactors is currently influenced by the criticality of the step, the value of the product and the time for product development and production.

The development of quality agreements has long been recognised as a critical activity to ensure a product's quality meets regulatory requirements.