Manufacturing

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.

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The agency publishes draft guidance on assessing the adhesion of transdermal delivery systems and topical patches.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

W.R. Grace & Co. will sell its chromatography product lines, which includes chromatography instruments, columns, and other related products.

Packaging technologies for serialization, parenteral products, and solid-dosage forms were displayed at INTERPHEX 2016.

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.

In this article, the authors look at the limitations of the validation for a single-use shipping system and provide a perspective on what shipping validation means.

This article examines the changes now taking place, and what the future might bring.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Intact enables aseptic filling in non-classified environments, maintains sterility throughout the process, and reduces costs, timelines, and contamination risks.

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

*Updated May 11, 2016Following JHL Biotech’s opening of a FlexFactory flexible manufacturing facility in Hsinchu, Taiwan in 2014, the company opened a second manufacturing location in Wuhan, China on May 10, 2016. According to the company, with the addition of the new Wuhan facility, JHL Biotech will now hold the largest volume of single-use cell-culture capacity in all of Asia.

The agency cited Apotheca Supply, a repackager and relabeler of pharmaceuticals for CGMP violations.

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.