Manufacturing

Frank Kofi Bedu-Addo, PhD, is vice-president, Purification Operations and Biopharmaceutics, at KBI BioPharma, Inc.

Articles

The author covers the fundamentals of lyophilization and provides case studies about the development of lyophilized biopharmaceutical products and the importance of biophysical characterization in formulaiton and the lyophilization process.

Understanding Lyophilization Formulation Development

Michael Thomas is associate scientist at Lyophilization Technology, Inc.

Electrical resistance, low temperature scanning calorimetry, and freeze-drying microscopy are three analytical methods that can be used to determine the thermal characterization of a product during processing for intended development of a lyophilization cycle.

Low-Temperature Thermal Analysis are Key to Formulation Design

Louis Rey, PhD, is biologist, scientific and industrial adviser, and lyophilization pioneer based in Switzerland.

Though recognized by the public since freeze-dried coffee hit the market 30 years ago, lyophilization remains far from mature and deserves more research.

The Saga of Freeze-Drying

FDA's aseptic processing draft guidance and the industry's state-of-the-art isolator technologies prepare manufacturers for the next generation of contamination control solutions.

Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators

Jeff L. Folks is director of business development at Quintiles (Kansas City, MO).

Isolator technology can be used in clinical product formulation and filling facilities to ensure environmental control and reduce contamination risk in aseptic processing.

Aseptic Formulation and Filling Using Isolator Technology

Glenn E. Wright is chairman of the PQRI Aseptic Processing Working Group and a director of global regulatory affairs at Eli Lilly and Company.

Members of FDA, industry, and academia formed a working group within PQRI to openly discuss topics from a scientific perspective and provide formalized clarifications and recommendations to FDA to be considered and incorporated into FDA's draft guidance on aseptic processing.

The PQRI Aseptic Processing Working Group: What was it? What Did It Cover? What Conclusions Did It Reach? Why Was It Important?

Richard L. Friedman is a microbiologist and is a senior compliance officer for sterile drugs and chairs CDER's Aseptic Processing Guideline Revision Working Group.

The authors describe the solicitation of industry input for the guidance through a process that included a 2002 meeting of the Advisory Committe on Pharmaceutical Science and the subsequent formation of the PQRI Aseptic Processing Working Group.

FDA Perspectives: Revising the 1987 Industry Guideline The Development of FDA's Guidance on Aseptic Processing

Anne Marie Dixon-Heathman  is the owner and president of Cleanroom Management Associates, Inc.

Training for aseptic processing cleanrooms must be a dynamic process to meet job requirements and industry demands. The author discusses various approaches that may be taken to ensure a successful training session.

Training for Aseptic Processing Environments

Shireesh P. Apte, PhD, is a lead scientist at Baxter I.V. Systems Inc.

As parenteral drug delivery becomes more complex and sophisticated, excipients that can facilitate drug (or gene) delivery to specific therapeutic targets will be required. An overwhelming majority of these excipients are derived from natural sources.

A Review of Classification of Emerging Excipients in Parenteral Medications

Steve Hansen is a technical services director at MKS Methuen, 651 Lowell St., Methuen, MA 01844, tel. 978.682.4567 ext. 4646.

Measurements of lyophilization pressure are accurate only if the gauges that are used have been properly calibrated.

Manufacturing, Parenterals and Injectables