Equipment

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

EMD Millipore will provide process development services for Precision Biologics’ preclinical monoclonal antibody.

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

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

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

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

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

Innovative polyethylene film sets new benchmark

What challenges do biopharmaceutical manufacturers face when deciding to move from a fed batch process to a continuous process?

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

Catalent's Advasept platform uses blow-fill-seal technology to aseptically manufacture, fill, and seal a polymeric primary container for injectable drugs.

Both upstream and downstream processes can benefit from continuous manufacturing advantages.

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.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

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.

Budgets for biopharmaceutical activities are gaining in select functional areas except outsourcing.

Critical issues that should be considered when scaling up a hot-melt extrusion process.

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

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.

Contamination is almost always related to human error and there is a clear drive to reduce human implications in aseptic operations. This can be achieved in multiple ways.

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.

The future, and increasingly the present, for aseptic operations is isolated robotics. Companies that wish to gain competitive advantages in their operations are stepping up and taking notice.

In a 2004 guidance, FDA says that the "use of redundant sterilizing filters should be considered in many cases." But not all manufacturers agree on what redundant filtration is.

Powder Systems Ltd's (PSL's) new GFD™ isolator combines the latest innovation to provide a high containment lab scale filtration and drying solution with the same reliability and benefits as PSL high containment production size filter dryers.

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.