Development

Articles

Could flexible manufacturing change the standards for biopharmaceutical production? To find out, Equipment and Processing Report talked to James Robinson, vice-president of technical and quality operations at biotechnology company Novavax (Rockville, MD).

Biopharmaceutical Manufacturers Look for Flexibility

The authors sought to improve the productivity of protein synthesis by using a highly active cell-free extract from Escherichia coli and by optimizing buffer conditions and shaking conditions.

Large-Scale Protein Production with a Cell-Free System

Recent advances in microreactor technology are improving the application and scale at which the technology can be applied.

Are Microreactors Practical for Large-Scale Production?

The manufacturing process, which influences a drug's safety and efficacy, is particularly critical for drugs administered through injection, and personnel must closely supervise lyophilization to ensure product quality.

Reducing Supercooling during the Lyophilization of Biologicals

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

Is FDA's Draft Process-Validation Guidance a Mixed Blessing?

A manufacturing line can be improved if technology transfer is implemented thoughtfully. Effective technology transfer helps to provide process efficiency and control and maintain product quality.

Technology Transfer Provides Manufacturing-Process Control

Whether you advance your technology from concept to commercialization or use a third party for parts or all of this work, the ability to do technology transfer flawlessly is essential to successful, efficient pharmaceutical production.

The Soft Side of Technology Transfer: Developing Trust

Specialty Pharmaceutical Company Bentley Pharmaceuticals has entered into an agreement with Cardinal Health for the scale-up of clinical supplies for Bentley's intranasal insulin product candidate.

Bentley, Cardinal Health to Scale-Up Clinical Supplies for Intranasal Insulin

Arlington, VA (Sept. 12)-At the American Association of Pharmaceutical Scientists meeting here, &quote;Real World Applications of PAT and QbD in Drug Process Development and Approval" (Sept. 11-12), chemical engineer and process modeler Michael L. Thompson, PhD, described how Procter & Gamble (West Chester, OH, www.pg.com) applies these mathematical tools to increase product quality and reduce development and trouble-shooting time for consumer and pharmaceutical products.

Mathematical Modeling Speeds Process Scale-Up and Transfer at P&G

Although agitation improves drying efficiency and ensures uniformity of the final dry material, it can also affect the physical properties of the product as it dries. This study evaluates the effect of scale up and equipment selection on an active ingredient undergoing granulation during the drying process.

Scale Up