Manufacturing

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

Glatt Ingenieurtechnik has added compact continuous agglomeration equipment and new control systems to its "modular plant engineering" portfolio.

Optima will also display the freeze dryer CS and the sterility test isolator STISO at the show.

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

The sterility test isolator (STISO) for testing aseptically filled drug products and for testing toxic aseptic drugs (STISOtox) from Metall+Plastic, a subsidiary of Optima, are modular and ergonomically designed.

GEA and Perceptive Engineering will collaborate to promote and deploy multivariate monitoring and advanced process control (APC) solutions for batch and continuous pharmaceutical process units.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.

The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.

The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.

Pharmaceutical machine concepts for large and small factories of the future need to be readily available, flexible when it comes to processing variation, and modular in design.

Netzsch will present a new compact grinding/separating system, LabCompactPlus, for chemical, pharmaceutical, and cosmetic laboratories at Achema 2018.

CoorsTek will highlight two new ceramic membrane filter technologies at the show-the multi-tube system, which consists of four single ceramic tubes connected together into a single ceramic part, and the hollow fiber system, which consists of ceramic tubes assembled into a high-density module.

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.

Innovations in fill/finish equipment and in solid-dosage moisture-control packaging technologies were on display at INTERPHEX 2018.

As more continuous processes move toward commercialization, users and equipment vendors are working to speed changeovers and address other needs.

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Aerobic bioprocesses are highly dependent upon the oxygen transfer rate (OTR) from sparged to dissolved gas. The relatively low solubility of oxygen, however, makes the choice of mixer impeller configuration a critical design factor for the bioreactor vessel. This article describes a series of experiments and computational fluid dynamics (CFD) simulations to detail the effect of mixer configuration on the efficiency and effectiveness of a bioreactor vessel with respect to blend time and mass transfer.

Advanced data analytics tools are used by industry to find the golden nuggets in historical data, to aid in process development, to fine-tune production, and to achieve long-term improvements in product quality and throughput.

Choosing the right contamination control platform requires considerable research into what a product needs for an effective process design.

Ready-to-use components eliminate the need for component preparation by the drug product manufacturer, enabling them to streamline their processes and focus on their core competencies, such as drug product development and manufacturing.

ASTM’s E-55.05 committee aims to turn best practices into industry standards in order to eliminate variability and allow a 70-year-old process to leverage 21st century tools, technologies, and practices.

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials--and the respective limitations--aids in selecting the most appropriate method for testing.

Environmental monitoring, which operates below the limit of detection, is little more than a rote exercise that provides limited real value. So why does it figure so prominently in current regulatory requirements for aseptic manufacturing?

Recent technological advances help streamline the fill/finish manufacturing process.

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes.