Manufacturing, Lyophilization

Alternative approaches to freeze-drying are gaining popularity and will help to overcome some of the challenges associated with conventional lyophilization.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

PCI Pharma Services is investing $100 million in manufacturing capabilities and capacity expansion to its Bedford, NH facility.

The Luna Probe One-Step RT-qPCR Mix with UDG is designed to enable sensitive, linear, real-time detection of target RNA sequences.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

Nexus Pharmaceuticals celebrated a new manufacturing facility in Pleasant Prairie, Wis.

SP Scientific Products’ SP Hull LyoStar 4.0 R&D freeze dryer supports rapid freeze-dry cycle development, optimization, and process scale-up.

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

The general principle of lyophilization has hardly changed, but significant advances have occurred in process and product attribute understanding.

The author provides an overview of common residual moisture methods for lyophilized drug products and key points to consider during method selection and method development.

Technical advances in process understanding and control must be accompanied by a change in mindset.

Non-destructive surface area measurement can improve stability testing.

Bosch Packaging Technology will present its new modular freeze dryer at Achema 2018.

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

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.

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.

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

Researchers at Purdue University and and industry experts have partnered up at the Advanced Lyophilization Technology Hub to optimize the 70-year-old freeze-drying process.

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

Focused around Purdue University’s LyoHUB, a new blueprint aims to bring innovation to equipment and processes. One goal? Continuous freeze drying.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

Recipharm is investing EUR3.7 million (approximately $4.18 million) to increase lyophilization capacity at its Masate facility in Italy.

The company manufactures biological drug products and intermediates for the allergy vaccine market.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

Non-destructive container closure integrity testing allows 100% inspection of all ampoules, syringes, vials, and cartridges.

Headspace moisture analysis is a rapid non-destructive analytical method that may potentially address the limitations of traditional methods used for residual moisture determination.

The expansion will enable relocation of its North American headquarters from Grayslake, Illinois.

With drug development trends shifting towards personalized medicines, new technologies are needed for the manufacture of these highly sensitive drug products.