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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...

Citation:
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. http://dx.doi.org/10.12665/J152.Lorenzi.

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...

Citation:
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. http://dx.doi.org/10.12665/J152.Grobholz.

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...

Citation:
Witcher MF. Using lifecycle and quality by design (QbD) approaches to define, plan, and execute biopharmaceutical projects. BioProcess J, 2016; 15(1): 10–7. https://dx.doi.org/10.12665/J151.Witcher.

Posted online April 7, 2016.

 
Serum: What, When, and Where?

by Rosemary J. Versteegen, PhD
Volume 15, Issue 1 (Spring 2016)

For over 80 years, fetal bovine serum (FBS) and other animal-derived materials have been widely used in the production of vaccines, and more recently, biotherapeutics, for both human and animal applications. Ever since FBS was initially developed as a cell culture reagent, there have been efforts made to avoid the use of this critical commodity. The International Serum Industry Association (ISIA) recognizes the requirement for robust risk assessment and management, and has several ongoing programs designed to help mitigate the risk of using animal-derived materials. This article will provide an outline of the state of the industry and of these programs...

Citation:
Versteegen RJ. Serum: what, when, and where? BioProcess J, 2016; 15(1): 18–21. https://dx.doi.org/10.12665/J151.Versteegen.

Posted online April 7, 2016.

 
Fetal Bovine Serum: Risk Management

by William Siegel
Volume 15, Issue 1 (Spring 2016)

Safety is typically viewed, perhaps unconsciously, as the result of a collection of factors, conditions, or behaviors. For example, consider “safety” in the context of personal, financial, or travel. With each, safety is defined as a set of component risks that have been managed to satisfactory levels for a particular situation. The same is true for product safety and risk, whether it be for raw materials or finished goods. The “safe” use of fetal bovine serum (FBS) is achieved by the management of controllable risks to a level that is acceptable for each particular application. For example, risk reduction requirements for research applications are not as stringent as for diagnostic, therapeutic, or manufacturing applications. Each end-user must decide on the level of risk reduction that is appropriate for their application...

Citation:
Siegel W. Fetal bovine serum: risk management. BioProcess J, 2016; 15(1): 22–5. https://dx.doi.org/10.12665/J151.Siegel.

Posted online April 7, 2016.

 
Development and Assessment of a Novel Device for the Controlled, Dry Thawing of Cryopreserved Cell Products

by John M. Baust, PhD, William L. Corwin, PhD, Kristi K. Snyder, PhD, John G. Baust, PhD, and Robert G. Van Buskirk, PhD
Volume 15, Issue 1 (Spring 2016)

While playing an integral role in biotechnology and medicine, cryopreservation (CP) is often viewed as a “simple tool” and is overlooked as a critical and evolving component of cell and tissue bioprocessing. Despite this, cryopreservation serves as an enabling technology in numerous areas including the latest cell therapies. For example, over one third of the cells used in clinical trials are cryopreserved using the traditional methods, which in many cases yield suboptimal outcomes. Further, researchers still rely on the assessment of cell survival immediately post-thaw (within a few hours), and fail to account for the impact of cryopreservation-induced delayed-onset cell death (CIDOCD) which continues to impact survival from hours to days post-thaw. Interestingly, despite the fact that CP research remains in a growth phase that focuses on the role of the cellular molecular response to CP stress, these discoveries, and the resultant paradigm shift, have yet to filter into mainstream utilization. Given the crucial role of CP, coupled with other challenges needed to keep pace with modern biomedicine, we have embarked on a goal of developing a novel device and protocol designed to enable rapid, controlled, multi-sample, and high-throughput thawing in an effort to improve overall sample viability and function post-thaw. We have achieved this with the development of the SmartThaw™ device. Studies were conducted using human prostate cancer cell (PC-3) and human mesenchymal stem cell (hMSC) samples cryopreserved using standard, controlled-rate freezing protocols and then thawed with SmartThaw. Post-thaw survival results were equivalent or improved, as compared to traditional water bath approaches, depending on the freezing media utilized. All SmartThaw experiments were achieved in a clean, dry, sterile field with real-time monitoring of the sample thaw thermal profile. Study results suggest that SmartThaw outperforms traditional methodologies. Importantly, these investigations are providing new technologies and direction that are built on a cell/molecular foundation that helps accelerate research, technology, and procedure development initiatives in which CP serves as an enabling component. Further, improvements in standardized sample thawing devices and protocols may pave a path for increased use of cryopreserved cells in clinical applications that enable improved post-thaw viability, homing, biodistribution, and engraftment...

Citation:
Baust JM, Corwin WL, Snyder KK, Baust JG, Van Buskirk RG. Development and assessment of a novel device for the controlled, dry thawing of cryopreserved cell products. BioProcess J, 2016; 15(1): 30–41. https://dx.doi.org/10.12665/J151.Baust.

Posted online April 7, 2016.

 
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