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Failure Mode and Effect Analysis (FMEA) as a Quality by Design (QbD) Tool for Managing Biopharmaceutical Product Development and Manufacturing Risks

by Mark F. Witcher, PhD
Volume 13, Issue 3 (Fall 2014)

This paper examines FMEA as a QbD tool. If FMEA’s strengths are used and weaknesses understood, it can be effectively used within a QbD feedback algorithm to identify, analyze, prioritize, and remediate biopharmaceutical development and manufacturing risks.

Citation:
Witcher MF. Failure mode and effect analysis (FMEA) as a quality by design (QbD) tool for managing biopharmaceutical product development and manufacturing risks. BioProcess J, 2014; 13(3): 39–46. http://dx.doi.org/10.12665/J133.Witcher.

Posted online October 13, 2014.

 
Contract Pharma Manufacturer Optimizes Quality Check Process With the Cubis Lab Balance

by Matthias Ude
Volume 13, Issue 3 (Fall 2014)

As a contract manufacturing organization (CMO) in this environment, it is essential for hameln pharma to deliver goods to their customers reliably, in terms of quantity, delivery time, and quality. Therefore, the topic of quality assurance plays a huge role— for both final packaged units as well as for bulk products. After a long-term analysis of the bulk product weighing process, hameln pharma’s objective was to significantly streamline the time-consuming process of manual counting and visual inspection. Moreover, taking cGMP standards into account, they wanted to optimize their existing process in order to remove any possibility of incomplete package volumes. Katrin Strasser, hameln pharma’s operational excellence expert, explained that: (1) packing box weights fluctuated with humidity levels during their manufacture; (2) labels for product packages varied; and (3) the actual number of items in a box carton were not always consistent.

Citation:
Ude M. Contract pharma manufacturer optimizes quality check process with the Cubis lab balance. BioProcess J, 2014; 13(3): 61. http://dx.doi.org/10.12665/J133.Ude.

Posted online October 13, 2014.

 
Validation Study of the Vi-CELL XR for Dendritic Cell Counting

by Iveta Bottová, PhD, and Lena Lee
Volume 13, Issue 3 (Fall 2014)

Dendritic cell (DC) population is a key functional constituent of cell-based immunotherapy drugs. The correct cell count and adequate viability of DCs are one of the quality control criteria for the final product release. The number of viable DCs is historically determined by microscopy using a manual counting method: Bürker chamber, and trypan blue dye for dead cell exclusion. The manual method can have significant variability between cell counts determined by different people performing the procedure, which may contribute to an unstable manufacturing process. The manual method is also timeconsuming for the operator. An automated cell counting process helps remove the variability between operators and can free up the operator for other tasks. The Vi-CELL® XR is an automated cell counting and viability analyzer that uses the trypan blue dye exclusion method. The Vi-CELL was evaluated as a suitable method for quality control of DC counts and viability for a dendritic cell-based biologic drug. The test for Vi-CELL counting accuracy was performed three times each on known concentration control beads, under the same operating conditions. The diameter and circularity of dendritic and lymphocyte cells was determined by a NIKON™ Eclipse microscope to set up the “correct recognition of DC. The size range for DC was established so that lymphocytes could be excluded. The number of total DC, viable and also non-viable, were analyzed and compared to Bürker chamber counting. There was no significant difference between the DC count obtained by Vi-CELL and by Bürker chamber. Vi-CELL automated cell counting was established as a method which is accurate and suitable for use with dendritic cells.

Citation:
Bottová I, Lee L. Validation study of the Vi-CELL XR for dendritic cell counting. BioProcess J, 2014; 13(3): 32–7. http://dx.doi.org/10.12665/J133.BottovaLee.

Posted online October 13, 2014.

 
Validation of a Chromogenic Substrate Method for Biological Activity Quantification of Streptokinase

by Ana Aguilera, Lázara Muñoz, Yilian Bermúdez, Danae Arias, Yamila Martínez, Gerardo García, Luciano Hernández, Eduardo Martínez, and Rodolfo Valdés
Volume 13, Issue 3 (Fall 2014)

The use of thrombolytic agent, streptokinase (SK), has been adapted to treat patients with the medical condition, hemorrhoids, in a new pharmaceutical formulation. Part of the development process included studies for measuring SK biological activity in the suppository product. Thus, the main objective in this study was in adapting and validating an established chromogenic substrate method for biological activity quantification of SK extracted from suppositories. By using several solutions and methods described in this paper, results revealed 103.82–124.99% of SK biological activity recovery and high molecular integrity. The chromogenic substrate method was specific for SK, and linear from 200– 600 IU mL-1 (R2 = 0.995 ± 0.002) with a variation coefficient of less than 7.11% and 12.62% for repeatability and reproducibility experiments, respectively. SK biological activity values estimated by the chromogenic substrate method were comparable with those estimated by the clot lysis method used as the reference. We have concluded that the method validated in this study was specific, accurate, and precise for quantifying biological activity of SK extracted from a suppository formulation intended to treat patients with acute hemorrhoids.

Citation:
Aguilera A, Muñoz L, Bermúdez Y, Arias D, Martínez Y, García G, Hernández L, Martínez E, Valdés R. Validation of a chromogenic substrate method for biological activity quantification of streptokinase. BioProcess J, 2014; 13(3): 49–59. http://dx.doi.org/10.12665/J133.Valdes.

Posted online October 13, 2014.

 
Production of Kojic Acid by Aerobic Aspergillus Fermentation

by Sudarshan Lakhawat, Jignesh Chaudhary, and Amrendra Nath Pathak
Volume 13, Issue 3 (Fall 2014)

Kojic acid is produced industrially by the Aspergillus species using aerobic fermentation processes. Kojic acid has applications in several fields such as the pharmaceutical, food production, cosmetics and dermatology, agriculture, and chemical industries. The production of kojic acid is greatly increasing, based on the demands of these industries, and studies focused on improved processes are ongoing. This article will discuss the methods written about by various members of the scientific community.

Citation:
Lakhawat S, Chaudhary J, Pathak AN. Production of kojic acid by aerobic Aspergillus fermentation. BioProcess J, 2014; 13(3): 62–9. http://dx.doi.org/10.12665/J133.Lakhawat.

Posted online October 13, 2014.

 
Insect Cell-Based Recombinant Adeno-Associated Virus Production: Molecular Process Optimization

by Jacek Lubelski, PhD, Wim Hermens, PhD, and Harald Petry, PhD
Volume 13, Issue 3 (Fall 2014)

An increasing number of clinical trials, and the recent approval of the first gene therapy in Europe, alipogene tiparvovec (Glybera®, uniQure), holds promise for recombinant adeno-associated virus (rAAV) to become a mainstay in clinical practice. Since the molecular cloning of AAV in the 1980s, a plethora of production protocols/manufacturing systems for generating rAAV vectors have been developed. uniQure’s manufacturing platform, which has received validation through regulatory approval, is also capable of supporting industrial-scale production based on the baculovirus expression vector system (BEVS) and insect cells. In this paper, we review the molecular process optimization of the various components of uniQure’s rAAV production platform...

Citation:
Lubelski J, Hermens W, Petry H. Insect cell-based recombinant adeno-associated virus production: molecular process optimization. BioProcess J, 2014; 13(3): 6–11. http://dx.doi.org/10.12665/J133.Lubelski.

Posted online October 2, 2014.

 
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