Quality by design for a vaccine release immunoassay: a case study.

Background: As quality by design (QbD) for pharmaceutical product development is being expanded to include analytical methods, we applied QbD to the development of antigenicity assays measuring in vitro relative potency of a quadrivalent vaccine candidate.

Results: After establishing development targets together with customers, immunoassays were developed to meet objectives. Statistical design of experiments was used to optimize method parameters and establish a design space.

Rapid automation of a cell-based assay using a modular approach: case study of a flow-based Varicella Zoster Virus infectivity assay.

Vaccine manufacturing requires constant analytical monitoring to ensure reliable quality and a consistent safety profile of the final product. Concentration and bioactivity of active components of the vaccine are key attributes routinely evaluated throughout the manufacturing cycle and for product release and dosage. In the case of live attenuated virus vaccines, bioactivity is traditionally measured in vitro by infection of susceptible cells with the vaccine followed by quantification of virus replication, cytopathology or expression of viral markers.

Microwave ablation with triaxial antennas tuned for lung: results in an in vivo porcine model.

Purpose: To prospectively determine in swine the size and shape of coagulation zones created in normal lung tissue by using small-diameter triaxial microwave antennas and to prospectively quantify the effects of bronchial occlusion and multiple antennas on the coagulation zone.

Materials And Methods: The study was approved by the research animal care and use committee, and all husbandry and experimental studies were compliant with the National Research Council's Guide for the Care and Use of Laboratory Animals. Twenty-four coagulation zones (three per animal) were created at thoracotomy in eight female domestic swine (mean weight, 55 kg) by using a microwave ablation system with 17-gauge lung-tuned triaxial antennas.

Multiple-electrode radiofrequency ablation: comparison with a conventional cluster electrode in an in vivo porcine kidney model.

Purpose: To compare multiple-electrode radiofrequency (RF) ablation versus RF ablation with a cluster electrode in an in vivo porcine kidney model.

Materials And Methods: Thirteen female pigs (mean weight, 45 kg) were used for the study. In each animal, RF ablations were performed for 12 minutes with a conventional cluster electrode in one kidney (controls, n = 13) and a multiple-electrode configuration in the contralateral organ.

Microwave ablation with multiple simultaneously powered small-gauge triaxial antennas: results from an in vivo swine liver model.

Purpose: To prospectively investigate the ability of a single generator to power multiple small-diameter antennas and create large zones of ablation in an in vivo swine liver model.

Materials And Methods: Thirteen female domestic swine (mean weight, 70 kg) were used for the study as approved by the animal care and use committee. A single generator was used to simultaneously power three triaxial antennas at 55 W per antenna for 10 minutes in three groups: a control group where antennas were spaced to eliminate ablation zone overlap (n=6; 18 individual zones of ablation) and experimental groups where antennas were spaced 2.

Multiple-electrode radiofrequency ablation of hepatic malignancies: initial clinical experience.

Objective: The objective of our study was to retrospectively analyze our initial clinical experience with percutaneous multiple-electrode radiofrequency ablation and evaluate its safety and efficacy for treating hepatic malignancies.

Materials And Methods: Thirty-eight malignant hepatic tumors (mean diameter, 2.7 cm; range, 0.

Microwave ablation with a single small-gauge triaxial antenna: in vivo porcine liver model.

Purpose: To evaluate the performance of a 17-gauge triaxial antenna at microwave ablation in an in vivo porcine liver model.

Materials And Methods: This study was approved by the institutional animal care and use committee. Thirteen female domestic pigs (mean weight, 45 kg) were used.

Multiple-electrode radiofrequency ablation creates confluent areas of necrosis: in vivo porcine liver results.

Purpose: To prospectively evaluate, in vivo in pigs, an impedance-based multiple-electrode radiofrequency (RF) ablation system for creation of confluent areas of hepatic coagulation.

Materials And Methods: The study was preapproved by the institutional research animal care and use committee. A prototype multiple-electrode RF system that enables switching between three electrically independent electrodes at impedance spikes was created.

Multiple-electrode radiofrequency ablation: simultaneous production of separate zones of coagulation in an in vivo porcine liver model.

Purpose: A multiple-electrode radiofrequency (RF) system was developed based on switching between electrodes that allows for the simultaneous use of as many as three electrically independent electrodes. The purpose of this study was to determine if each multiple-electrode ablation zone is identical to an ablation zone created with conventional single-electrode mode.

Materials And Methods: Nine female domestic pigs (mean weight, 90 kg) were used for this study.