Manufacturing, Continuous Solid Dosage Processing

A CPHI North America panel discussion forewarns that CDMO supply chains are potentially the biggest single risk to product resilience.

As new manufacturing processes and technologies are introduced to meet demand and overcome challenges, understanding also needs to improve to ensure the right balance is achieved.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.

The guide reviews unit operations and establishes equipment requirements for continuous manufacturing of oral solid dosage forms.

Collaboration and new tools aid efforts to implement new processing technologies for small-molecule drug product manufacturing.

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

New processes, automation, and digitalization were highlighted in 2021.

Sharon Nowak, Business Development Manager, Coperion K-Tron USA Food & Pharmaceutical Industries spoke about feeding equipment in solid-dosage drug manufacturing.

Fernando Muzzio, PhD, Distinguished Professor of Chemical and Biochemical Engineering at Rutgers University, spoke about trends in continuous manufacturing of OSD drugs.

Johannes Khinast, PhD, Institute for Process and Particle Engineering in the Research Center Pharmaceutical Engineering (RCPE) at the Graz University of Technology in Austria, spoke about continuous manufacturing of OSD drugs.

Dave DiProspero, director of Pharmaceutical Process Technology at CRB, spoke about equipment trends in solid-dosage drug manufacturing.

Evolving equipment designs meet the unique needs of continuous processing techniques.

Consider best practices for manual or clean-in-place procedures.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Continuus Pharmaceuticals is building the first GMP facility using integrated continuous manufacturing technology for end-to-end production of small-molecule APIs and finished dosage forms.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

Advanced manufacturing technologies are available, but challenges need to be addressed.

A contract from the US government will help fund domestic US production of small-molecule APIs and finished dosage forms and will be the first GMP facility using ICM technology.

Early adopters and equipment manufacturers refine their equipment and processes, paving the way for broader use.

For certain APIs, including semi-synthetic antibiotics, continuous filtration and drying improves productivity and quality.

Early adopters and equipment manufacturers refine their equipment and processes, paving the way for broader use.

Experts at Hovione describe progress being made in understanding how to optimize continuous processes for oral solid-dosage drug products.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

Using a specific addition method to wet the powder bed in twin-screw granulation using a foam binder improves robustness for continuous solid-dosage drug product manufacturing.

Real-time monitoring and the principles of quality by design were used to optimize an OSD coating process.

The continuous manufacturing platform can be used for individual unit operations or a complete solid-dosage manufacturing line and can be integrated with third-party equipment.

Advanced analytics streamlines continuous manufacturing by providing improved insights to data.

Tools help improve understanding of excipient risk in formulating OSD drugs.

Long a staple for quality by design and solid dosage form manufacturing, design of experiments is becoming an integral part of biopharma upstream process development.