Manufacturing

The agency cited the company for sterile manufacturing violations.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

Computerized systems can solve some of the data integrity problems with conventional paper-based systems.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.

Pharmaceutical Technology sat down with Charles N. Kettler, PhD, director of Natoli Scientific, to discuss the Natoli Institute for Industrial Pharmacy at Long Island University.

Customized puresu single-use fluid path assemblies from Watson-Marlow Fluid Technology Group incorporate tubing and BioPure components and are supplied ready to use.

There are technical hurdles to clear in developing serialization and track-and- trace programs, but it’s the human ones that are proving most difficult to surmount.

Effective harvesting and purification processes play an essential role in ensuring that biopharmaceutical manufacturing processes provide biologic drug substances with uniform and consistent properties.

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.

Uncertainty about the demand for a biologic medication can be partly mollified with some well-planned capacity outsourcing, contends a new report by ORC International sponsored by Patheon.

Preheating pinch valves prevents drift in the volume of liquid dispensed.

FDA and bio/pharma companies get serious about continuous manufacturing to ensure product quality.

Industry experts discuss common considerations and recent technological advancements in blow-fill-seal technology.

Process analytical technology paved the way for continuous manufacturing.

Different types of modular systems have advantages and disadvantages.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

Experts discuss the key considerations in the development of an autoinjector.

This article presents recommendations based on a program that was set up to qualify members of a large, diverse team at one oral solid-dosage-form manufacturing facility.

As the battle for ownership over the use of CRISPR to edit DNA heats up, some of the CRISPR pioneers refocus their efforts to demonstrate the technology’s applications for editing RNA.

The company expanded its topicals capacity with an investment in the Becomix RW30 model homogenizer.

Live Track focus tracking technology on the Renishaw inVia Qontor Raman microscope enables the analysis of samples with uneven, curved, or rough surfaces.

Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia .

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

The Thermo Scientific TruScan RM Analyzer features a chemometrics package that allows users to build customized models for both qualitative and quantitative sample predictions.

The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.

Xellia, a generic anti-infective drug manufacturing company, is constructing a laboratory services building at its manufacturing site in Budapest, Hungary.