Manufacturing

Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

Senior Editor Agnes Shanley reviews key points pharma companies should address to meet global requirements for pharma supply chain safety. Hear how pharma companies can address the concerns such as drug counterfeiting, adulteration, and drug shortages.

The countdown has begun for one of the biggest trade shows for the process industry.

While biotech will revolutionize our industry through new products and new reaction pathways, process analytics is the link between process automation and the laboratory sector, and water plays a key role as a valuable resource all over the world.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Appropriate feeding equipment can be selected to meet the challenges of dosing powders that are sticky or do not flow well.

Pharmaceutical Technology spoke with Tim Kearns, pharmaceutical and medical devices manager at Videojet.

OXY-CAPT brings together properties of plastic and glass containers through the combination of oxygen absorption and cyclic olefin copolymer (COP) high barrier layers.

Medicago's new production facility will make plant-based vaccines and therapeutics.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Economic benefits, equipment availability, research results, and FDA support are driving progress in continuous processing.

Optical inspection equipment for packaging was displayed at INTERPHEX 2015.

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

Symbiosis Pharmaceutical Services is now offering a new bulk lyophilization (freeze drying) service in response to increasing demand in the manufacture of bulk intermediates and APIs by lyophilization.

Janssen pledges $6 million to Rutgers CSOPS for continuous manufacturing research.

Alexion will construct a biologics facility in Ireland that is its first outside the US.

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

This article looks at data gathered from several studies of a widely marketed chlorobutyl rubber formulation used for vial stoppers and prefilled syringes.

This study evaluates the impact of controlled nucleation on the ability to optimize a lyophilization cycle for a monoclonal antibody formulation.

Traditional sterility testing methods can take 14 days or longer to complete, so a growing number of pharmaceutical manufacturers and quality control

The use of disposables requires careful consideration and planning.

Total cost of ownership, including operating costs, must be considered when deciding between flexible and traditional cleanroom systems.