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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.

 
Opinion

by Donald L. Jarvis, PhD
Volume 15, Issue 3 (Fall 2016)

I have to begin with a disclosure. I am a card-carrying, old-school, hypercritical academic who has always been among the first to complain about going to a conference and having to sit through an infomercial disguised as a science talk. But, perhaps I have a disguise of my own. I actually enjoy hearing talks focused on applied research and product development at least as much as more “academic” talks. I admire and respect the practical application of brilliant science. I believe that’s what scientists are supposed to do...

Citation:
Jarvis DL. Opinion. BioProcess J, 2016; 15(3): 5. https://doi.org/10.12665/J153.Jarvis.

Posted online November 15, 2016.

 
Low-Pressure Liquid Chromatography Using the EcoPrime® With Enhanced Buffer In-Line Dilution

by Mary Jo Wojtusik, PhD and Kurt Willner
Volume 15, Issue 3 (Fall 2016)

Chromatography and buffer in-line dilution (BID) are integrated on the same low-pressure liquid chromatography (LPLC) system combining two unit operations into a single, space-saving platform. The EcoPrime’s BID option will significantly reduce buffer storage and lower operating expenses associated with buffer preparation...

Citation:
Wojtusik MJ, Willner K. Low-pressure liquid chromatography using the EcoPrime® with enhanced buffer in-line dilution. BioProcess J, 2016; 15(3): 14–9. https://doi.org/10.12665/J153.Wojtusik.

Posted online November 15, 2016.

 
Quality Risk Management (QRM): Part I – Identifying, Evaluating, and Mitigating Threat Risks to Biopharmaceutical Enterprises

by Mark F. Witcher
Volume 15, Issue 3 (Fall 2016)

The FDA’s ICH Q9 quality risk management (QRM) guidance material is the foundation for understanding and evaluating patient risks associated with developing and manufacturing pharmaceuticals. This three-part paper describes approaches a team of subject matter experts (SMEs) can use for implementing two important applications of QRM. Part I provides a method for identifying and remediating threat risks that may affect the product’s quality or other important aspects of a manufacturing enterprise’s lifecycle, from product research and development to commercial manufacturing. The second QRM application covered in Part II manages patient risks by identifying, evaluating, and managing risks associated with process parameters (PP) on the product’s critical quality attributes (CQAs). The final paper, Part III, describes an approach for accepting or further mitigating the risks evaluated by the QRM exercise...

Citation:
Witcher MF. Quality risk management (QRM): part I – identifying, evaluating, and mitigating threat risks to biopharmaceutical enterprises. BioProcess J, 2016; 15(3): 21–9. https://doi.org/10.12665/J153.Witcher.

Posted online November 15, 2016.

 
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