Development

Articles

When I run a small production batch of a particular formulation with the same tablet press used to develop it, I get compressibility and disintegration issues. What am I doing wrong?

Scaling Up a Tableting Process

The authors share their approach and experience working in complex, multicompany environments for in-licensed products to develop successful chemistry, manufacturing, and controls packages for managing outsourcing partnerships.

Managing Technology Transfer: Developing a Complete CMC Package for an In-Licensed Product

Antonello Barresi is Professor of Process Design and Development at Politecnico di Torino.

The same recipe obtained in laboratory-scale equipment cannot, without modifications, generally be used to freeze-dry the product in a pilot-scale or industrial-scale freeze-dryer.

Overcoming Common Lyophilization Scale-Up Issues

The authors highlight the need for a technology-transfer process that is efficient, cost-effective, and repeatable, stressing the importance of process understanding. Read this and other preferred organization articles in this special issue.

Keys to Executing a Successful Technology Transfer

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

FDA Publishes Revised Process-Validation Guidance

Maik Guttzeit is Head of Quality Assurance at GEA Pharma Systems, Germany.Tel: +49 2233 6999 401 

This article examines the difficulties in designing lyophilisation processes that can be faithfully scaled up to production volumes and suggests the most effective ways in which this can be achieved.

Designing An Effective PAT-Driven Scale-Up Of Lyophilization Processes

The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.

Strategic Approaches to Process Optimization and Scale-up

The authors discuss a continuous-flow reactor that avoids parallel channels and enables economic plant setup. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

Microstructured Reactors for Rapid Process Development and Scale-Up

If you’ve worked in the drug industry for a while, chances are good that you remember Pfizer’s Rezulin, which was produced through hot melt extrusion (HME). If you work for a major pharmaceutical manufacturer, it’s likely that your company owns a twin-screw extruder. Yet HME has not been a common way of manufacturing drugs, and many industry employees don’t understand the principles of HME or the advantages that the technique offers.

Is Hot Melt Extrusion an Untapped Resource?

Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?

Scale Up