Manufacturing, Continuous Solid Dosage Processing

Eli Lilly was awarded the 2017 FOYA Overall Winner for its continuous direct compression manufacturing installation projects.

Rutgers University-based C-SOPS annual meeting described advances in continuous manufacturing understanding and future plans for broader education efforts.

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

Coperion K-Tron has added the K3-PH-ML-D4-QT35 design to the company’s K3-PH line of feeders for a variety of continuous processes, and will showcase the feeder at the 2017 ISPE Annual Meeting and Expo.

Support from FDA, a best practice guide, collaborative research, and new facilities signify progress in solid-dosage continuous manufacturing.

The Portable, Continuous, Miniature, and Modular (PCMM) collaboration is alive and well, and the second generation of its modular continuous manufacturing equipment is now available.

The European Medicines Agency approved Prezista (darunavir) made via a continuous manufacturing process at Janssen's facility in Puerto Rico.

The pharmaceutical industry is making efforts by internally assessing, developing, and implementing semi-continuous manufacturing processes to improve manufacturing efficiencies.

Bosch’s Xelum platform is designed for continuous production of oral solid-dosage forms.

Advances in equipment, instrument, and control systems are enabling online monitoring of continuous API manufacturing.

Although technical paths for continuous solid-dosage manufacturing have been laid out and equipment and control systems have been developed, industry is slow to move forward.

Advances in process analytical technology have been achieved, but significant challenges remain.

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

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

PharmTech’s 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.

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

FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico.

Pharmaceutical Technology spoke with Bill Randolph, vice-president, Technical Services, Janssen Supply Chain, about some of the considerations for technology transfer of a continuous, solid-dosage manufacturing process and what he sees as the outlook for continuous manufacturing.

Hovione will operate a commercial-scale continuous manufacturing facility in New Jersey as part of an agreement with Vertex Pharmaceuticals.

Economic benefits, equipment availability, research results, and FDA support are driving progress in continuous processing.

Progress in equipment availability, process analytical technology, and advanced process control aids ongoing development of continuous solid-dosage manufacturing processes.

Doug Hausner, Engineering Research Center for Structured Organic Particulate Systems, Rutgers University discusses continuous manufacturing for solid-dosage drug production.

Experts will examine continuous processing in solid-dosage and biopharmaceutical production.

The collaboration with Pfizer aims to develop next-generation, continuous manufacturing for solid-dosage pharmaceuticals.

Industry is moving toward closed-loop control of continuous processing.

The requirements of a granule drying process haven't really changed much in recent years.