Manufacturing

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

The agency prepares a plan to implement new packaging safety features.

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

AMETEK announced the acquisition of Brookfield Engineering Laboratories, a Massachusetts based manufacturer of viscometers and rheometers.

LabConnect built a biorepository facility in Tennessee.

Common defects in tablet film coating can be minimized by effective design of the tablet core and the coating process.

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.