Downstream Processing

The European Medicines Agency has added granularity to its biosimilars approval pathway by releasing a guideline on mAbs.

NIBRT's Ian Nelligan on what to expect when starting a downstream process.

Michiel E. Ultee of Laureate Biopharmaceutical Services gives an update on 1988 article regarding virus testing and how the advance of monoclonal antibodies has changed processes.

The authors describe a validation master plan for closed-vial filling technology.

Steven S. Kuwahara, PhD, principal consultant at GXP BioTechnology LLC, gives an update on "Engineering the Cell-System Interface."

Industry wants more innovation, but can suppliers meet customers' needs?

Panayiotis P. Constantinides of Biopharmaceutical & Drug Delivery Consulting on growth of nanoparticle delivery systems.

A review of key industry shifts and promises for the future.

Industry experts discuss significant achievements. Plus: What's in store for the future.

This article discusses potential opportunities to improve the patient experience through formulation and delivery device technologies.

MAb polishing using salt tolerant interaction membrane chromatography.

Industry experts discuss the benefits and challenges of self-administration of injectable therapies.

A technical rountable featuring Sartorius Stedim Biotech, Pall Life Sciences, 3M Purification, Asahi Kasei Bioprocess, and Bio-Rad Laboratories.

The authors describe a new assembly for bulk and final drug product filling operations.

Demonstration of large-scale stem-cell scale-up.

Recombinant albumin can stabilize a drug product and assist in API release.

Key business considerations when developing biosimilar products virtually.

The authors compare the exposure risk from viable particles from the air supply in four well-established aseptic filling technologies.

Has an approval in oncology reignited interest in the recruitment of the immune system in the fight against disease?

This month, we rewind to "Separations Technology Outlook, Part II: Improved Recovery and Greater Purity."

Approaches for risk assessment of extractables and leachables.

The authors describe a novel means to control ice nucleation using a sterile cryogenic ice fog.

Can a nanofiltration process be leveraged for removal of prions?

Readers react to the economic turmoil of the past year and look longingly forward to 2012.

With careful analysis to mitigate risk, disposable technology and process closure can enable adaptable designs and reduced costs.