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Eco-Friendly Red Pigment Production by Sporosarcina aquimarina

by Vigi Chaudhary, Aditi Goyal, Jignesh Chaudhary, and A.N. Pathak
Volume 15, Issue 3 (Fall 2016)

Acetyl-4, 4′-diapolycopene-4, 4′-dioate, a C30 carotenoid and secondary metabolite, was produced by the Sporosarcina aquimarina bacteria using a 5.0 L fermentation vessel with a 3.0 L working volume. In the presence of tryptone, the biosynthesis of acetyl-4, 4′-diapolycopene-4, 4′-dioate production using a batch fermentation process was further improved. Production parameters like carbon source, pH, and temperature were studied, and maximum product was achieved, up to 1.2 g/L, where the secondary metabolite yield was 0.07 g/L and productivity, 0.00833 g/L/h. The organic constitution and significant red color intensity of the acetyl-4, 4′-diapolycopene-4, 4′-dioate molecule can be used in the textile industry as a dye, and a coloring additive in processed foods and pharmaceuticals...

Chaudhary V, Goyal A, Chaudhary J, Pathak AN. Eco-friendly red pigment production by Sporosarcina aquimarina. BioProcess J, 2016; 15(3): 44–51.

Posted online November 15, 2016.

Using a Patient-Centered Risk-Benefit Structure and Appropriate Manufacturing Practices (AMPs) for Successfully Developing and Manufacturing Effective Cell Therapy Products

by Mark F. Witcher, PhD
Volume 15, Issue 2 (Summer 2016)

The development and manufacturing of advanced breakthrough cell therapies presents a wide variety of complex challenges that include:
• delivering the medical science, from research all the way through product development and clinical testing, to the patient population;
• understanding and defining the product’s modes of activity and the cell’s attributes necessary to attain therapeutic benefit and safety;
• overcoming significant manufacturing, logistical, and cost of goods issues associated with using attachment-dependent bioreactor systems; and
• defining product release challenges associated with rapidly delivering an effective product to the patients.
Successfully meeting these challenges requires new lifecycle development and manufacturing approaches based on understanding a complete set of patient goals that go beyond safety to include both efficacy and the patient’s ability to access the therapy. For many of these complex therapies, safety is perhaps the easiest of the three goals. Establishing both product and process comparability from the very beginning is required to assure the product successfully makes it through the product development sequence. The new approaches must also be based on appropriate manufacturing practices (AMPs) over the product’s lifecycle, from the earliest research phases, process development, clinical manufacturing, and finally to commercial manufacturing, to keep the development effort focused and efficient. This paper describes approaches built on product and process lifecycle paradigms that emphasize both product and process validation to assure product comparability over the entire manufacturing lifecycle, from research through commercial production. Methods previously used for chemical entity pharmaceuticals, and even protein biopharmaceuticals, are not adequate for cellular therapeutics being developed from recent advances in medical science’s understanding of complex therapeutic pathways. The safety and efficacy of cell-based therapies may be impacted by subtle and difficult-to-measure changes in the performance or behavior of the manufacturing process. In addition, the patient’s access to cell therapies is heavily impacted by the complexity and cost of developing adherent bioreactor technologies required to expand and/or modify therapeutic cells...

Witcher MF. Using a patient-centered risk-benefit structure and appropriate manufacturing practices (AMPs) for successfully developing and manufacturing effective cell therapy products. BioProcess J, 2016; 15(2): 22–9.

Posted online July 30, 2016.

Preformulation Studies and Physicochemical Properties of Intranasal Low Sialic Acid Erythropoietin

by A. Muñoz-Cernada, PhD, J. Cardentey-Fernández, L. Paradina-Fernández, L. Rojas-del Calvo, T. Figueredo-Gonzáles, D. Rodríguez-Abreu, M. Fernández-Cervera, PhD, I. Sosa-Testé, PhD, and D. Amaro-González, PhD
Volume 15, Issue 2 (Summer 2016)

Intranasal low sialic acid erythropoietin (Neuro-EPO) is a non-hematopoietic molecule that shows neuro-protective activity in some rodent models of brain ischemia. The protein formulations are susceptible to a loss of stability due to formulation, processing, and storage. The aim of this study was to perform formulation analyses of Neuro-EPO to achieve acceptable stability. Experiments were done to assess the compatibility of Neuro-EPO with selected excipients: benzalkonium chloride (BAC) preservative, sodium chloride (NaCl), and hydroxypropyl methylcellulose (HPM) K4M polymer. Instabilities were induced by creating thermal stress conditions (25 ± 2°C). Protein degradation was measured using sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)/Western blot, reversed-phase high-pressure liquid chromatography (RP-HPLC), and size-exclusion HPLC (SE-HPLC). Neuro-EPO excipient compatibility tests showed instabilities with BAC, which seemed to be related to protein aggregation. Non-preserved formulations maintained a biological activity similar to that observed with the formulation preserved...

Muñoz-Cernada A, Cardentey-Fernández J, Paradina-Fernández L, Rojas-del Calvo L, Figueredo-Gonzáles T, Rodríguez-Abreu D, Fernández-Cervera M, Sosa-Testé I, Amaro-González D. Preformulation studies and physicochemical properties of intranasal low sialic acid erythropoietin. BioProcess J, 2016; 15(2): 45–51.

Posted online July 30, 2016.

Simulation of Process Performance on Contaminant Removal Using Constant and Non-Constant Volume Diafiltration Modeling

by Renato Lorenzi, Bala Raghunath, PhD, Yanglin Mok, and Karen Chan
Volume 15, Issue 2 (Summer 2016)

Constant volume diafiltration (CVD) is commonly used in the biopharmaceutical industry for impurity removal or buffer exchange. The number of diavolumes is usually determined empirically or by theoretical analysis to achieve the target degree of impurity removal. There is, however, a lack of conclusive information about the effect of contaminant removal in variable volume diafiltration (VVD). VVD can occur when the diafiltration control mode is not functioning as intended. In this study, a mathematical model has been proposed to predict removal efficiency during VVD. Experiments were performed to compare the results to model calculations. A dilute concentration of bovine serum albumin solution was used as the feed solution to study variable volume effects. Study results demonstrate that the contaminant removal rate is higher when the diafiltration flow rate is lower than the permeate flow rate (flux). The simple analytical expression for contaminant removal presented in this article, developed and supported by the experimental results, serves as a guide for the optimization and troubleshooting of industrial diafiltration processes. The expression verifies the diafiltration process performance when it deviates from the traditional constant volume approach, with the assumption that the contaminant has no interactions with the product...

Lorenzi R, Raghunath B, Mok Y, Chan K. Simulation of process performance on contaminant removal using constant and non-constant volume diafiltration modeling. BioProcess J, 2016; 15(2): 30–7.

Posted online July 30, 2016.

Operator Safety in Biopharmaceutical Manufacturing: The Role Raw Material Suppliers Can Play in Contributing to a Safer Production Environment

by James Grobholz
Volume 15, Issue 2 (Summer 2016)

The proper handling of commonly used chemicals in bioprocessing is critical to maintaining a safe working environment as well as operational efficiency. Chemical mishandling can lead to failed batch processes, quality issues, as well as lost time and resources. As new technologies designed to help mitigate these safety risks become available, biomanufacturers have more opportunities to ensure that their production environments are safe. As a raw materials supplier, MilliporeSigma believes suppliers can play a critical role in terms of providing product and packaging solutions designed to minimize chemical handling risks...

Grobholz J. Operator safety in biopharmaceutical manufacturing: the role raw material suppliers can play in contributing to a safer production environment. BioProcess J, 2016; 15(2): 38–42.

Posted online July 30, 2016.

Using Lifecycle and Quality by Design (QbD) Approaches to Define, Plan, and Execute Biopharmaceutical Projects

by Mark F. Witcher, PhD
Volume 15, Issue 1 (Spring 2016)

The world in general, and biopharmaceuticals in particular, are becoming increasingly complex and challenging. The ability to plan and execute a project to efficiently and effectively achieve a high-quality project goal is especially important for developing and manufacturing biopharmaceutical products. Managing projects ranging from product development, process characterization and validation, to building new manufacturing facilities requires straightforward, effective project management approaches and tools. But perhaps even more importantly, managing a project is a fundamental enabling skill required to manage both oneself as well as teams of people. Many complex approaches and tools exist for managing projects. However, elaborate tools are rarely used, leaving many projects managed by loose, unstructured, firefighting methods. In other cases, complex tools add unnecessary time-consuming overhead and confusion. Simple, easy to understand and use methods provide a structured approach to efficiently reach the desired deliverables and goals. This paper is intended to aid in realizing complex biopharmaceutical challenges by providing a straightforward approach using QbD feedback loops within a structured project lifecycle. This article also provides an excellent example of how a well thought-out lifecycle approach can be used to understand and solve complex problems. We begin by looking at the three elements of a project...

Witcher MF. Using lifecycle and quality by design (QbD) approaches to define, plan, and execute biopharmaceutical projects. BioProcess J, 2016; 15(1): 10–7.

Posted online April 7, 2016.

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