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Using Product Lifecycle, Process Validation, and Quality by Design (QbD) Paradigms to Efficiently Take New Biopharmaceutical Products from Pre-IND to Commercial Manufacturing

by Mark F. Witcher, PhD
Volume 14, Issue 1 (Spring 2015)

This paper describes how a biopharmaceutical product development effort can be structured to identify, understand, and plan activities and goals required to efficiently and rapidly deliver new products and therapies to patients. Although the paper focuses on manufacturing, the approach can be used for all aspects of pharmaceutical product development from establishing an intellectual property position, developing a comprehensive manufacturing plan, to creating a marketing program.

Citation:
Witcher MF. Using product lifecycle, process validation, and quality by design (QbD) paradigms to efficiently take new biopharmaceutical products from pre-IND to commercial manufacturing. BioProcess J, 2015; 14(1): 30–5. http://dx.doi.org/10.12665/J141.Witcher.

Posted online April 15, 2015.

 
Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology

by Timothy J. Hahn, PhD et al.
Volume 14, Issue 1 (Spring 2015)

For the ongoing 2014 Ebola virus outbreak, all viable options and technologies need to be evaluated as potential countermeasures to address this emerging biological threat. Novavax, Inc. has a rapid, practical vaccine development and manufacturing platform with the capability to deliver clinical trial material and, ultimately, commercial doses in response to novel infectious disease agents. This report describes the application of our platform technology for the successful generation, manufacture, and release of a clinical batch of Zaire ebolavirus glycoprotein nanoparticle vaccine three months from project initiation...

Citation:
Hahn TJ et al. Rapid manufacture and release of a GMP batch of Zaire ebolavirus glycoprotein vaccine made using recombinant baculovirus-Sf9 insect cell culture technology. BioProcess J, 2015; 14(1): 6–14. http://dx.doi.org/10.12665/J141.Hahn.

Posted online February 10, 2015.

 
Streamline Your Cell Line Screening: With the Automated, Microscale, Stirred Tank, Single-Use Bioreactor

by Tim Ward
Volume 13, Issue 4 (Winter 2014/2015)

The price per patient for protein-based and monoclonal antibody (mAb) therapies runs into thousands of dollars per patient each year. These therapies cost considerably more to manufacture than small molecules. Hence, if mammalian or insect cell lines expressing high protein titres can be selected and optimized for protein expression using microscale bioreactor models early in development, then manufacturing costs can be reduced significantly...

Citation:
Ward T. Streamline your cell line screening: with the automated, microscale, stirred tank, single-use bioreactor. BioProcess J, 2015; 13(4): 60–1. http://dx.doi.org/10.12665/J134.Ward.

Posted online January 20, 2015.

 
Biopharmaceutical Manufacturing: Historical and Future Trends in Titers, Yields, and Efficiency in Commercial-Scale Bioprocessing

by Ronald A. Rader and Eric S. Langer
Volume 13, Issue 4 (Winter 2014/2015)

This article documents the progress, current state, and projected future trends in titer and yield as industrial and technological benchmarks for commercial-scale biopharmaceutical manufacture. Biopharmaceutical product commercial-scale manufacturing (bioprocessing) was benchmarked by tracking titers and yields over time, from the 1980s to the present, and further out ten years. This study compiled commercial-scale titer and yield data for a set of 39 major biopharmaceuticals, nearly all mammalian-expressed proteins, particularly, monoclonal antibody products. This included extensive searches of many potential data sources, including contacting knowledgeable bioprocessing professionals. In the 1980s and early 1990s, average titers at commercial scale started out at < 0.5 g/L. The current average reported commercial-scale titer is 2.56 g/L. We also confirmed that the manufacture of commercial products has, over the years, undergone repeated cycles of technical production upgrades, with titers and yields increasing incrementally, even for the oldest products. BioPlan estimates that ≥3 g/L is now the industry standard titer for new bioprocesses being developed, with ≤7 g/L now presumed to be the general industry top-end titer level that, while not unusual, is not often achieved. In terms of yields, we found a 70% yield to be the current industry average yield, not the often-cited 75%. Improvements in downstream purification technologies (e.g., as demonstrated by higher yields) have been fewer and adopted more slowly than upstream production...

Citation:
Rader RA, Langer ES. Biopharmaceutical manufacturing: historical and future trends in titers, yields, and efficiency in commercial-scale bioprocessing. BioProcess J, 2015; 13(4): 47–54. http://dx.doi.org/10.12665/J134.Langer.

Posted online January 20, 2015.

 
In Situ Hybridization: The Importance of Ultrapure Water for RNA Technologies

by Frauke Nitzki and Elmar Herbig
Volume 13, Issue 4 (Winter 2014/2015)

In situ hybridization (ISH) for localization of DNA/RNA hybrids in cytological preparations was first described in 1969 by Gall and Pardue. This method enables mRNA transcripts to be detected in tissue sections. Unlike expression analyses based on polymerase chain reactions, the exact localization of the target transcripts can be identified within the tissue...

Citation:
Nitzki F, Herbig E. In situ hybridization: the importance of ultrapure water for RNA technologies. BioProcess J, 2015; 13(4): 56–9. http://dx.doi.org/10.12665/J134.NitzkiHerbig.

Posted online January 20, 2015.

 
Use of Interactive Laser-Scanning Imaging Cytometry (ILIC) for Real-Time Cytotoxicity Assessment of Bacteriocins Against Cultured Mammalian Cells

by Shelton E. Murinda, PhD, Robert F. Roberts, PhD, Elaine M. Kunze, and Kamal A. Rashid, PhD
Volume 13, Issue 4 (Winter 2014/2015)

The evaluation of bacteriocin cytotoxicity is a critical first step in guaranteeing its safe use in food and therapeutic applications. In this study, the bacteriocins nisin, pediocin, and colicin ([Col] E1, E3, E6, E7, and K) were evaluated for cytotoxicity against cultured mammalian cells. Cellular membrane potential (ΔΨ) changes of bacteriocin-treated cells were used as an index of cytotoxicity. Simian virus 40-transfected human colon (SV40-HC) cells and African green monkey kidney epithelial cells (Vero) cells were cultured (35°C, 10% CO2, humidified air) as monolayers on tissue culture plates. Log phase cells (~104 cells/mL) were treated with partially purified, individual bacteriocin preparations at 170, 350, and 700 activity units (AU)/mL. Perturbations in cellular ΔΨ were measured using interactive laser-scanning imaging cytometry (ILIC) with 3,3’-dipentyloxacarbocyanine iodide (DiOC5[3]), a potential-sensitive, fluorescent dye. Cellular ΔΨ studies indicated significant levels of dose-dependent toxicity with nisin, pediocin, and colicins E6, E7, and K. In contrast, Col E1 and E3 had no definitive toxic impact on SV40-HC cells. The only colicin to significantly impact Vero cells negatively was the E6. Overall, SV40-HC cells demonstrated greater sensitivity to bacteriocins than Vero cells. Among all the fluorescence parameters and peak statistics measured, the integrated area under the curve appeared to correlate best with the prediction of cytotoxic events. Consequences were quickly apparent with maximum changes occurring within 3–5 minutes following the addition of test substances. Refinements in the ILIC protocol could potentially afford a unique tool for rapid, real-time cytotoxicity testing of bacteriocins in food preservation, and in human and animal health applications...

Citation:
Murinda SE, Roberts RF, Kunze EM, Rashid KA. Use of interactive laser-scanning imaging cytometry (ILIC) for real-time cytotoxicity assessment of bacteriocins against cultured mammalian cells. BioProcess J, 2015; 13(4): 21–32. http://dx.doi.org/10.12665/J134.Murinda.

Posted online January 20, 2015.

 
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