Manufacturing

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

The International Society for Pharmaceutical Engineering (ISPE) Facility of the Year Awards (FOYA) program announced its 2016 Category Award winners for operational excellence, sustainability, process innovation, project execution, equipment innovation, and facility integration.

Hazardous reagents can simplify processes and provide higher yields and purities.

Catalent plans a $4.6 million investment to expand secondary packaging and storage in Asia.

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.

Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

Real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures are improving the shipment of sensitive pharmaceuticals.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Hermes Pharma has commercially implemented hot-melt coating (HMC) technology at its production facility.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

Baxter has voluntarily recalled lots of IV solutions due to potential container leakages and particulate matter.

Pharma companies reduce the impact of manufacturing on the environment with innovations in energy and waste treatment.

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

The Alfa Laval Safety Valve, a true spring-loaded safety valve, is designed to protect both equipment and people.

FuelCell Energy plans to install a 5.6 megawatt fuel cell power generation system for Pfizer to provide reliable and low carbon electricity and steam for its 160-acre R&D facility in Groton, CT.

The company has voluntarily recalled one lot of magnesium sulfate in water for injection because of incorrect labeling.

Takeda Pharmaceuticals announced the acquisition of a biopharmaceuticals manufacturing plant in Minnesota.

The Cell Therapy Catapult, University of Birmingham, and Cancer Research Technology collaborate on CAR-T cell immuno-oncology therapy development.

FDA discusses a new program that allows pharmaceutical companies to submit proposals for new manufacturing technology.

Jones Packaging and ThinFilm will collaborate on NFC OpenSense technology for pharmaceutical packaging.

Parenteral packaging of the future will include more automated lines, ready-to-fill packaging formats, and supply-chain transparency.

DAVID LEAHY/GETTY IMAGESThe pharmaceutical industry has an important role to play in implementing solutions to global envi

The 10-ppm criterion for the acceptable concentration of potential API in cleaning validation to minimize cross contamination into next product has been employed for many years. This article describes why the 10-ppm criterion, which was established based on analytical limitations and estimates of acceptability, is no longer necessary and why a risk-based approach should be universally adopted.

The revised USP Chapter 1207 gives best practices for obtaining reliable data in container closure integrity testing.

Amid corporate restructurings, regulatory initiatives, and aging R&D assets, will drug development accelerate or stall in 2016?

The Ross AMK Kneader Extruder combines the technologies of a double-arm mixer with an extrusion screw.