Manufacturing

Articles

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

Miron Ludzinski is a senior research scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company.

Madhav Kamat, PhD, RPh, is a senior principal scientist at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company, One Squibb Drive, New Brunswick, NJ 08993.

Amol Mungikar, PhD, is a research investigator at Biopharmaceutics R&D, Drug Product Processing and Packaging Technologies, Bristol-Myers Squibb Company.

The authors describe a comprehensive methodology for establishing functional equivalence among various lyophilizers.

Evaluating Functional Equivalency as a Lyophilization Cycle Transfer Tool

Henning Gieseler, PhD, works in the Department of Pharmaceutics at the University of Erlangen, Erlangen, Germany 91058. tel. +49 9131 85 29545, gieseler@freeze-drying.eu.

Tony Kramer works at the Ecolab Research Center in Eagan, Michigan.

Stefan Schneid works in the Department of Pharmaceutics at the University of Erlangen in Erlangen, Germany.

Cycle design and robustness testing using advanced process analytical technology.

Peer-Reviewed Technical Note: Quality by Design in Freeze-Drying

pharmaceutical science and technology news

April 2004

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

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

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, Lyophilization