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Showing 1 to 20 of 36 for “"lyophilization"”.
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Material Handling for Continuous Lyophilization Process
… details solutions to two main challenges with a lyophilization machine: load-lock door design for isolating process chambers from the environment and other process chambers operating at different conditions and vacuum seals for complex geometries that are robust to significant temperature …
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Method for Continuous Inspection of Product Weight During Lyophilization
During lyophilization, a freeze-drying process used to stabilize pharmaceuticals, vials filled with product go through stages to sublimate out the water contained in the initially frozen product. The final product is a solid with a low water content which is more stable for shipping. This work …
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Protection Mechanisms of Excipients on Lactate Dehydrogenase during Freeze-Thawing and Lyophilization
… dehydrogenase (LDH), during freeze-thawing and lyophilization. Cryoprotectants are excipients that protect labile molecules during freezing. Some investigators believe that preferential exclusion is the predominant mechanism to explain the cryoprotection of labile proteins by the polyethylene …
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Design of load-lock door for unit dose continuous lyophilization process for complex biologics
The process of unit dose continuous lyophilization consists of moving vials containing unit doses of pharmaceutical product though a series of process chambers with varying pressures and temperatures. In order to move the vials between process chambers with varying pressures without disturbing the …
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Design of a load-lock system for the lyophilization of unit-dose pharmaceuticals in a continuous manufacturing machine
Lyophilization, or freeze drying, of unit-dose pharmaceuticals eliminates the need to preserve quality through regulated temperature storage during transport. Typical lyophilization is performed through batch processing, but implementing continuous manufacturing instead can lead to improved process …
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Design and Manufacture of a Modular Continuous Unit Dose Pharmaceutical Lyophilizer
Pharmaceutical lyophilization (freeze-drying) enables long term storage and simplified transportation for aqueous vaccines and protein formulations. Modern industrial pharmaceutical freeze-driers rely on large batch and open loop formulation processing, limiting supply chains and resulting in …
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Functional stability of a nucleic acid-hydrolyzing single chain antibody in various biochemical and biophysical environments
… pH, storage period, reducing environment, lyophilization, and repetitive freeze-thaw. The DNA-binding activity and -hydrolyzing activity were maintained for 6 h at 50°C. The optimal pH showing the DNA-binding activity and -hydrolyzing activity was exhibited for 2 h at pH 7-11. The …
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Composite gelatin delivery system for bone regeneration
… and mechanical stability, an optimal lyophilization method was developed with initial freezing at -20⁰C for 1 day, followed by lyophilization of the scaffold for 1-2 days. In terms of mechanical properties of the gelatin and amount of protein delivered, the most effective loading of …
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Stable submicron protein particles : formation, properties, and pulmonary applications
… protein stabilities are high in conventional lyophilization, cooling rates are on the order of 1 K/min resulting in large 30 to 100 [mu]m sized particles. Thus, the intermediate cooling rate regime for SFL and TFF, relative to SFD and lyophilization, offers a promising route to form stable …
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Solid Lipid Nanoparticulate Formulation for ifosfamide: Development and Characterization
… The effect of chamber pressure during lyophilization of emulsions was studied by lyophilizing the emulsion at low pressure (high vacuum) and high pressure (low vacuum). Two products having distinct morphologies were obtained as a result of lyophilizing emulsion under different vacuum …
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Potential commercial application of a bi-layer bone-ligament regeneration scaffold to anterior cruciate ligament replacement
… and calcium phosphate minerals and the use of lyophilization to create a network where all the materials are homogeneously dispersed and present in significant amounts. This process allows the creation of a porous network whose physical characteristics, mechanical properties, and material …
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Purification of Recombinant HIS6-GFP-Preptin Fusion Protiens
… band corresponding to the target fusion protein. Lyophilization enabled long-term storage without loss of integrity. These findings establish a robust platform for the expression and purification of preptin analogs, supporting future efforts to characterize their biochemical activity and …
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Effect of Dried Mushroom Powder on Thiol Content in Lyophilized and Native Bovine Myofibrillar Protein
… protein as time and temperature changed. Lyophilization physically changes MP and it is recommended to not lyophilize myofibrillar protein for future thiol oxidation studies. The addition of 0.1% <em>P. ostreatus</em> powder may prevent thiol loss in MP.</p>
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Streamlining data management in drug product commercialization and manufacturing
… multivariate statistical process monitoring of lyophilization in clinical manufacturing, and (3) integration of development study data through electronic lab notebook software. Based on insights from these case studies, we make specific recommendations for further improvements in data management.
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Developing the business case for Quality by Design in the biopharmaceutical industry
… Smart Freeze Dryer technology, a novel means of lyophilization cycle development and temperature control.
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HPLC method development for the evaluation of pheromones from the dwarf African clawed frog Hymenochirus
… were used to concentrate the samples: sample lyophilization,..solid phase extraction (SPE), and direct sample loading. Different parameters such as the type and concentration of the phase modifier, wavelength for UV-detection, composition of the mobile phase, flow rate, and gradient elution …
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Development and Evaluation of Paclitaxel-Loaded Liposomal Formulations for Targeted Drug Delivery to Breast Cancer
… The leakage and vesicle size increase during lyophilization was minimized by using lyoprotectant sucrose in the formulation. Feasibility of developing gas-filled liposomes for ultrasound mediated drug delivery was evaluated using freeze drying gas entrapment method for the preparation. The …
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Development of Carbohydrate-based Diblock Polymers for Nucleic Acid Delivery
… which could be re-dissolved in water after lyophilization to yield nanoparticles. The polyplexes formulated with cationic diblock copolymers were shown to efficiently enter cervical cancer cells (HeLa cell line) and glioblastoma cells (U-87 cell line) and to deliver their nucleic acid cargo. …
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Using Esterase and Laccase Enzymes to Derivatize Bioactive Plant Phenolics for Altered Chemistry
… was not explained by enzyme inactivation during lyophilization. Still, alanine scanning mutagenesis revealed that R37A substitution improved activity of AF1753 on long-chain p-nitrophenyl (pNP) esters. A multicopper oxidase (SCO6712) from Streptomyces coelicolor displayed activity on a variety of …
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Drug-Polymer and Drug-Lipid Miscibility for the Development of Amorphous Solid Dispersions and Solid Lipid Nanoparticles
… trends regarding particle size were seen upon lyophilization. Miscibility of FLT with polymers and lipids demonstrated enhanced performance suggesting FLT SDs and SLNs would result in increased solubility and bioavailability.
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