Manufacturing, Lyophilization

Duke University researchers have found a possible alternative to lyophilization.

There are a variety of vaccine types, each varying in safety and efficacy, and each possessing its own formulation challenges. To overcome potential instabilities when developing vaccines, one formulation strategy is to produce a dried product.

The most important consideration when choosing a freeze dryer is to ensure the system is fit for both today's applications and future needs.

Pharmaceutical Technology Europe discusses some of the latest challenges and innovations in pharmaceutical lyophilization.

Last year, a member of the PTE editorial team attended the 2nd Annual Lyophilisation Conference in London (UK).

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.

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

Cycle design and robustness testing using advanced process analytical technology.

pharmaceutical science and technology news

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.

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.

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

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