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.

The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.

The tablet tooling manufacturer will showcase its products and services, which include an online training package and a tool management system for proactive monitoring of tooling rotations, inventory, and maintenance.

InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.

L.B. Bohle’s QbCon 1 laboratory-scale, continuous twin-screw granulator and dryer offers fully continuous drying for R&D in continuous solid-dosage manufacturing.

A new facility will allow Fette Compacting to double its production capacity for tablet presses in Nanjing, China.

Bosch’s Industry 4.0 solutions deliver full transparency for all process and machine data.

GE Healthcare’s new Sefia S-2000 cell processing system allows operators to conduct multiple cell therapy manufacturing steps with one instrument.

Romaco will display the IHD series for processing hot melt coatings at Achema 2018.

The company will invest EUR 325 million (US$389 million) in a new biomanufacturing facility in Ireland using single-use bioreactors.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

Dolomite Microfluidics has developed the Drug Encapsulation System to provide scientists with a simple and scalable way of encapsulating drug samples.

The MagMixer MBE Series from SPX Flow is suitable for low-viscosity blending, dissolving solids, and solid suspension in sterile applications.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

Updated guidelines and new technologies aid visual inspection of parenteral products and packaging.

Airflow visualization studies, or smoke studies, confirm unidirectional airflow patterns in an aseptic processing facility.

Integrated computerized systems for data collection improve data security and offer a solution for handling temporary data.

A skilled workforce is needed to deliver on technology’s promising medical advances.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

The working acceptance limits for acceptance values (AV) are determined using the critical values at, for example, 95% coverage over the corresponding AV distributions. However, validity of such limits needs to be elaborated.

Shipping biopharmaceuticals in single-use containers requires a thorough understanding of the distribution cycle and potential transportation risks.