Reconstitution & Transfer Systems
Lyophilization (“freeze-drying”) is the process of dehydrating a material (at low temperature and reduced pressure) to extend shelf life. Many biologic drug products are offered in lyophilized form. Important to subsequent administration is efficient reconstitution (i.e., rehydration). This section presents papers on the chemistry, products and processes of both lyophilization and reconstitution.
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Although plastic caps are a change of existing processes, they can satisfy an unmet need. This presentation discusses the impact of using plastic caps with regards to lyophilization, CCI data, functionality (forces, closing process), overcoming package component height tolerances/variation, extractables & leachables, and machinability.
<p>This article gives an overview of the process of lyophilization and the types of equipment employed.</p> <p><em>J. Barley</em></p>
<p>This article discusses the issues that can result from uneven ice nucleation across multiple vials in a lyophilization chamber, and temperature variation strategies that can address them.</p> <p><em>Adeline Siew. Pharmaceutical Technology 37 (5) (May 2, 2013)</em></p>
This article discusses the process of lyophilization in general, and considerations for inspection of lyophilization operations.
<p>This article discusses strategies to reduce reconstitution time for protein drug products that are highly concentrated, including modification to methods of lyophilization and reconstitution. Model protein had a molecular weight of 210,000 and drug product had a concentration 40 – 80 mg/mL. Accelerated methods had no effect on protein aggregation as demonstrated by size-exclusion high-performance liquid chromatography (SE–HPLC), Fourier-transform infrared (FTIR) spectroscopy, or sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS–PAGE). </p> <p><em>L.-F. H. Lin and R. Bunnell. BioPharm International, 26 (3) (2013)</em></p>