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Quality Risk Management (QRM): Part II – Evaluating the Impact of Process Parameters on Critical Quality Attributes for Biopharmaceutical Products

by Mark F. Witcher
Volume 15, Issue 4 (Winter 2016/2017)

This paper, the second in a three-part series on ICH Q9 quality risk management (QRM), uses a process-based risk structure to identify product quality risks from variability in input parameters and process behavior. This paper outlines a method to identify the three types of input parameters and how they can be placed into an ICH Q8 defined design space structured to clearly categorize and control the input parameters such that they can be evaluated for their impact on product critical quality attributes (CQAs). Based on their placement in the well-structured design space, the parameters are rated using a risk severity and uncertainty index to calculate a risk rating for review and acceptance. The process-based risk structure can also be used to mitigate the likelihood of the risk consequence by modifying the processes to manage the uncertainty of the input parameters and control the process’s behavior...

Citation:
Witcher MF. Quality risk management (QRM): part II – evaluating the impact of process parameters on critical quality attributes for biopharmaceutical products. BioProcess J, 2017; 15(4): 22–31. https://doi.org/10.12665/J154.Witcher.Q.

Posted online February 15, 2017.

 
Hydroxyethyl Starch Supplemented with Ice Recrystallization Inhibitors Greatly Improves Cryopreservation of Human Red Blood Cells

by Jessica S. Poisson, Jennie G. Briard, Tracey R. Turner, Jason P. Acker, and Robert N. Ben
Volume 15, Issue 4 (Winter 2016/2017)

Cryopreservation is a desirable method for the long-term storage of human red blood cells (RBCs). Current protocols employ high concentrations of glycerol that must be removed from thawed RBCs prior to transfusion. Small-molecule ice recrystallization inhibitors (IRI) can protect RBCs from cryoinjury during the freezing and thawing process in the presence of reduced amounts of glycerol. Although reducing the concentration of glycerol during freezing reduces post-thaw deglycerolization times, thawed RBC units still require post-thaw processing. Herein, we report the cryopreservation of RBCs using the non-permeating cryoprotective agent (CPA) hydroxyethyl starch (HES) supplemented with small-molecule IRIs: (1) PMP-Glc (110 mM); and (2) pBrPh-Glc (30 mM). The results demonstrate that 30 mM pBrPh-Glc in 11.5 % (w/w) HES affords quantitative post-thaw recovery of intact RBCs that are superior to those obtained using glycerol with slow cooling rates, and show the utility of small-molecule IRIs in cryopreservation...

Citation:
Poisson JS, Briard JG, Turner TR, Acker JP, Ben RN. Hydroxyethyl starch Supplemented with ice recrystallization inhibitors greatly improves cryopreservation of human red blood cells. BioProcess J, 2017; 15(4): 16–21. https://doi.org/10.12665/J154.Ben.

Posted online February 15, 2017.

 
A Novel Scalable Production Platform for Gene Therapy Vectors Based on Human Suspension Cell Lines

by Kerstin Hein, Simon Fradin, Helmut Kewes, Martina Graßl, and Nicole Faust
Volume 15, Issue 4 (Winter 2016/2017)

A rapid increase in the number of gene therapy trials and products has led to a comparable increase in the need for industrial production of viral gene therapy vectors such as lentiviral, adeno-associated, and adenoviral vectors. Current production systems are limited with respect to scalability and robustness. With our CAP® and CAP-T™ cell lines, we have developed a novel system for high-density suspension culture, efficient and reproducible transfection, and highly efficient production of viral vectors. By upstream process optimization, we have obtained a robust and high-density fed-batch culture system which can be scaled in any current bioreactor format. A design-of-experiments approach has been employed to optimize transient production of lentiviral vectors with significantly higher titers than can be obtained with adherent HEK293T cells...

Citation:
Hein K, Fradin S, Kewes H, Graßl M, Faust N. A novel scalable production platform for gene therapy vectors based on human suspension cell lines. BioProcess J, 2017; 15(4): 8–15. https://doi.org/10.12665/J154.Faust.

Posted online February 15, 2017.

 
Opinion
Using the ICH Q8 Design Space for ICH Q12 Lifecycle Knowledge Management

by Mark F. Witcher, PhD
Volume 15, Issue 4 (Winter 2016/2017)

One of the objectives of the upcoming ICH 12: Pharmaceutical Lifecycle Management guidance is to manage product development and manufacturing process information in order to establish and maintain appropriate change control over the entire product lifecycle. The 2014 ICH Q12 Concept Paper also stresses ICH Q12’s role in connecting ICH Q8 through ICH Q11 into a complete lifecycle approach to assure product quality and continuous improvement of manufacturing operations. However, neither the Concept Paper or subsequent public discussion and presentations appear to identify the ICH Q8 design space as a central mechanism for collecting and maintaining product and process information...

Citation:
Witcher MF. Using the ICH Q8 design space for ICH Q12 lifecycle knowledge management. BioProcess J, 2017; 15(4): 7. https://doi.org/10.12665/J154.Witcher.U.

Posted online February 15, 2017.

 
Opinion
POP Talk: Prepare, Organize, Present

by Tom Kost, PhD
Volume 15, Issue 4 (Winter 2016/2017)

You have worked tirelessly on your project and an opportunity arises to present your results. It might be a group meeting, departmental seminar, job interview, or scientific conference. Alternatively, you may need to raise money to fund your research, start a biotechnology company, or market a new product. In each of these instances, delivering your message effectively is essential to achieving your goal and earning the respect and admiration of colleagues...

Citation:
Kost T. POP talk: prepare, organize, present. BioProcess J, 2017; 15(4): 4–5. https://doi.org/10.12665/J154.Kost.

Posted online February 15, 2017.

 
Gamma Irradiation of Frozen Animal Serum: Dose Mapping for Irradiation Process Validation

by Bart Croonenborghs, Andy Pratt, Lorraine Bone, and Mara Senescu
Volume 15, Issue 3 (Fall 2016)

The treatment of animal serum by gamma irradiation is performed to mitigate the risk of introducing undesired microorganisms (viruses, mollicutes, or other microbes) into a cell culture. Serum manufacturers and end-users utilize irradiation contractors to perform this process. The irradiation process must be validated, which involves establishing the: (A) minimum dose that achieves the required inactivation of the microorganisms of interest; (B) maximum acceptable dose at which the serum still maintains all of its required functional specifications; and (C) process used by the contract irradiator that allows treatment of the serum product within these defined limits. In the present article, we describe the best practices for qualifying the distribution and magnitude of absorbed dose (performance qualification [PQ] dose-mapping) when serum is gamma irradiated. PQ dose-mapping includes the following: (1) documentation of dose distribution characteristics in defined product load configurations for a specified pathway through the irradiator; (2) assessment of the process capability of the defined product load configurations and irradiation pathway for respecting the dose specification for the serum; and (3) development of a method for routine dose monitoring of the irradiation process with the defined product load configurations and the specified irradiation pathway...

Citation:
Croonenborghs B, Pratt A, Bone L, Senescu M. Gamma irradiation of frozen animal serum: dose mapping for irradiation process validation. BioProcess J, 2016; 15(3): 7–13. https://doi.org/10.12665/J153.Croonenborghs.

Posted online November 15, 2016.

 
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