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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.

 
Monoclonal Antibody Generation and Characterization for Vip3Aa20 Protein Quantification in Transgenic Corn Plants

by Daily Hernández, Hasel Aragón, Marcos González, Gabriela González, Amarilis González, Andrés Tamayo, Ivis Morán, Pilar Téllez, Eduardo Sánchez, Miguel Castillo, Williams Ferro, Camilo Ayra, and Rodolfo Valdés
Volume 15, Issue 3 (Fall 2016)

Numerous standardized techniques for detection and quantification of proteins are based on polyclonal antibody (pAb) use. However, because pAbs are a heterogeneous mixture of antibodies, there is the possibility of non-specific interactions or cross-reactions with non-related proteins, which is a disadvantage in the detection and quantification of target proteins. Therefore, the main objective of this study was to generate and characterize monoclonal antibodies (mAbs) for quantifying the Vip3Aa20 protein of Bacillus thuringiensis (Bt) expressed in event MIR162 transgenic corn plants.

The Vip3Aa20 bioinsecticidal protein of Bt shares 99.7% of homology with the Vip3Aa1 protein, which has already been successfully isolated by affinity chromatography on metal chelate. For this reason, Vip3Aa1 was chosen as an antigen for obtaining mouse mAbs directed against these Bt δ-endotoxins. The mAbs were characterized by sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE)/Western blot, high-pressure liquid chromatography gel filtration (HPLC-GF), enzyme-linked immunosorbent assay (ELISA), and association constant. In general, results showed that the use of the highly purified mAbs not only allowed the specific and accurate quantification of Vip3Aa20 in extracts of macerated leaves of event MIR162 transgenic corn plants, but also statistically discriminated (p=0.000) between homozygous (range: 180–360 ng/mL, mean ± standard deviation [SD]: 241.7 ± 43.2 ng/mL) and hemizygous (range: 0–140 ng/mL, mean ± SD: 51.7 ± 40.8 ng/mL) transgenic corn plants grown under the same experimental conditions...

Citation:
Hernández D, Aragón H, González M, González G, González A, Tamayo A, Morán I, Téllez P, Sánchez E, Castillo M, Ferro W, Ayra C, Valdés R. Monoclonal antibody generation and characterization for Vip3Aa20 protein quantification in transgenic corn plants. BioProcess J, 2016; 15(3): 30–43. https://doi.org/10.12665/J153.Valdes.

Posted online November 15, 2016.

 
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...

Citation:
Chaudhary V, Goyal A, Chaudhary J, Pathak AN. Eco-friendly red pigment production by Sporosarcina aquimarina. BioProcess J, 2016; 15(3): 44–51. https://doi.org/10.12665/J153.Pathak.

Posted online November 15, 2016.

 
Gamma Irradiation of Animal Serum: An Introduction

by Rosemary J. Versteegen, PhD, Mark Plavsic, PhD, DVM, Raymond Nims, PhD, Robert Klostermann, and Karl Hemmerich
Volume 15, Issue 2 (Summer 2016)

This article serves as an introduction to a series of papers that are being authored under the sponsorship of the International Serum Industry Association with the purpose of establishing best practices for processes employed in the gamma irradiation of animal serum. It is comprised of a discussion about the role of serum in cell culture and the management of the associated risks. Additional articles in the series will address a number of topics of interest to the cell culture community, including, but not limited to: (1) performance of absorbed dose mapping for irradiators; (2) validation of the ef ficacy of pathogen reduction during gamma irradiation of animal serum; (3) comparability evaluation of irradiated serum; (4) product management throughout the irradiation process; and (5) ensuring a quality outcome when using gamma irradiation. The intent of the series is to increase awareness of the scientific community regarding the conduct of gamma irradiation and the strengths and limitations of this serum treatment approach for achieving the goals of adventitious agent risk mitigation...

Citation:
Versteegen R, Plavsic M, Nims R, Klostermann R, Hemmerich K. Gamma irradiation of animal serum: an introduction. BioProcess J, 2016; 15(2): 5–11. http://dx.doi.org/10.12665/J152.Versteegen.

Posted online July 30, 2016.

 
Gamma Irradiation of Animal Serum: Validation of Efficacy for Pathogen Reduction and Assessment of Impacts on Serum Performance

by Mark Plavsic, PhD, DVM, Raymond Nims, PhD, Marc Wintgens, and Rosemary J. Versteegen, PhD
Volume 15, Issue 2 (Summer 2016)

The treatment of animal serum by gamma irradiation, for the purpose of mitigating the risk of introducing a pathogen (virus, mollicute, or other microbe) into a cell culture, is a process that has been executed (and perhaps understood) primarily by irradiation contractors utilized by serum manufacturers. The selection of appropriate exposure conditions and irradiation doses is driven by a number of critical factors including: (1) the validation and control of the irradiation process itself; (2) the efficacy of the applied irradiation dose range for inactivating pathogens of interest; (3) determination and control of critical process attributes; (4) the potential impacts of these irradiation dose levels on the serum being irradiated; and finally, (5) the potential impact of irradiated serum on the medicinal product and the associated manufacturing process where serum is ultimately used. In order to increase awareness of these topics throughout the cell culture community, we have addressed these critical factors in the current review...

Citation:
Plavsic M, Nims R, Wintgens M, Versteegen R. Gamma irradiation of animal serum: validation of efficacy for pathogen reduction and assessment of impacts on serum performance. BioProcess J, 2016; 15(2): 12–21. http://dx.doi.org/10.12665/J152.Plavsic.

Posted online July 30, 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...

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

Posted online July 30, 2016.

 
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