Manufacturing

Soft sensors are powerful tools that can be used along with spectroscopic instruments in on-line measurement.

Continuous manufacturing will not work for all pharmaceuticals, but the right infrastructure, senior management support, and planning from the earliest stages of drug development could eventually allow up to 80-90% of small-molecule APIs to be made continuously, says Paul Sharratt, head of process science and modeling at Singapore’s Institute of Chemical and Engineering Sciences.

A venture between GEA and Siemens aims to familiarize more pharmaceutical companies with more modern control and continuous processing.

This novel technology was developed in response to challenges involved in conventional manufacturing of multilayer tablets, including in-line control of the tablet weight, the tendency to delamination, direct contact between the two tablet layers, and cross contamination.

Process analytical technology, based on monitoring particle size distribution and tracking coating thickness measurements in real time, can be used to predict the dissolution of polymer-coated multiparticulates.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.

Conferences focused on continuous solid-dosage manufacturing aim to spread the word about technical capabilities and alleviate perceptions of regulatory uncertainty.

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

Fisher BioServices will expand its CryoHub solution by co-locating it with the Cell and Gene Therapy Catapult manufacturing center for seamless supply chain management and to accelerate cell and gene therapy production.

Richard D. Braatz, PhD, will discuss using mathematical models to design a continuous drug manufacturing plant and the differences between batch and continuous operations for biologics.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

The company announced that it would now be offering a portfolio of fresh and cryopreserved human and animal hepatocytes for ADME-Tox testing.

An influx of millennial workers may have an impact on whether pharma manufacturers choose to implement IIoT technology.

FDA sent a warning letter to Lumis Global Pharmaceuticals Co. Ltd. detailing CGMP deficiencies regarding API repackaging, labeling, and misbranding.

INTERPHEX 2017 exhibitors focus on shelf life, traceability, and quality control.

An enterprise quality management software system can minimize human error and help pharmaceutical manufacturers maintain standard operating procedures to prevent deviations from GMP resulting from not having or following written procedures.

Transparency between pharmaceutical companies and suppliers and risk assessment efforts are vital to effective supply chain practices.

Known as the Fast Series, the company’s new line of preconfigured track-and-trace products are designed to help pharmaceutical companies comply with serialization requirements fast.

Schreiner MediPharm’s multi-functional booklet-label combines several digital security features with an integrated first-opening seal.

QF20kSU single-use pumps from Quattroflow are used for applications requiring gentle product handling, high containment, low pulsation, purity, and cleanability.

Herma’s 152E Wraparound Bottle Labeler eases integration of print and vision systems.

Banner Engineering’s Sure Cross U-GAGE K50U Ultrasonic Sensor is used for wireless tank monitoring.

The patented SKAN NANOX Catalysts enable higher efficiency breakdown of hydrogen peroxide at lower temperatures for shorter decontamination cycles.

Parenteral packaging will be well-represented at INTERPHEX, especially technologies associated with fill/finish of ready-to-use vials, cartridges, and syringes.

The company made a €42 million investment in a new building at its Reinbek site to support the production of biopharmaceuticals.