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Biopharmaceutical Manufacturing: Current Titers and Yields in Commercial-Scale Microbial Bioprocessing

by Ronald A. Rader and Eric S. Langer
Volume 14, Issue 4 (Winter 2015/2016)

This article reports the average titers and yields currently attained with commercially manufactured biopharmaceuticals expressed by microbial systems such as E. coli and yeasts. A recent BioProcessing Journal article comparably covered results from the first phase of this study concerning historical titers and yields attained for commercial-scale biopharmaceutical production using mammalian cells (e.g., CHO). As with this prior mammalian component, public domain data concerning titers and yields attained with microbially manufactured products were obtained using all available sources. These included a review of available literature and direct contact with over 200 bioprocessing professionals identified as involved in relevant product research and development, and manufacturing. Unexpectedly, current microbial titers with commercially manufactured products were found to be consistent with those previously determined for mammalian products. However, purification yields attained with microbial manufacturing averaged only about 15%. This is much lower than with mammalian products yielding approximately 69%. Despite low downstream yields, microbial bioproduction continues to be considered less costly, simpler, faster, and generally more economical than mammalian manufacturing...

Citation:
Rader RA, Langer ES. Biopharmaceutical manufacturing: current titers and yields in commercial-scale microbial bioprocessing. BioProcess J, 2016; 14(4): 51–5. http://dx.doi.org/10.12665/J144.Langer.

Posted online January 12, 2016.

 
Direct, Real-Time Antibody-Based Quantification of Baculovirus

by Michael Artinger, April Birch, Tyler Gates, Christopher Kemp, and Michael W. Olszowy
Volume 14, Issue 4 (Winter 2015/2016)

The impact of viruses—in geopolitical human health issues, in the production of vaccines and recombinant proteins, and in gene therapy and cancer treatments—highlights the need for a better understanding of the systems that are dependent upon them. A primary barrier to recognizing the full potential of these life-saving biomedical approaches is the scarcity of analytical methods capable of providing biologically relevant information without hindering the pace of development and production. ViroCyt® is a Colorado-based biotechnology company with one overriding focus: Enabling the rapid and specific quantification of viruses and virus-related particles. The ViroCyt Virus Counter® was designed to meet this objective. Until recently, the primary method employed by the Virus Counter for detecting virus was ComboDye, which utilized a general fluorogenic nucleic acid stain and a general fluorogenic protein stain to simultaneously label intact virus particles. The advantage of this approach is that it provides a broadly applicable reagent capable of quantifying many virus types. The disadvantage is that crude and/or complex matrices, in which there is high nucleic acid and/or protein background, can complicate the detection of individual virus particles. To address this issue, and to allow innovation to drive the technology into an expanded number of virus systems, ViroCyt recently created a second portfolio of reagents called ViroTag®. This technology employs fluorescently tagged antibodies specific for the virus of interest. The first members of this product line to be launched target two high-value viruses: baculovirus and human adenovirus. In this article, we focus on the application of the ViroTag system for rapid quantification during the bioprocessing of baculovirus-derived systems...

Citation:
Artinger M, Birch A, Gates T, Kemp C, Olszowy MW. Direct, real-time antibody-based quantification of baculovirus. BioProcess J, 2016; 14(4): 15–21. http://dx.doi.org/10.12665/J144.Artinger.

Posted online January 12, 2016.

 
Long-Term CB.Hep-1 Monoclonal Antibody Production in a Single-Use Bioreactor on a Rocker Platform with Serum- and Protein-Free Media

by Alberto Galván, Rodolfo Valdés, Marcos González, Hasel Aragón, Daily Hernández, Sigifredo Padilla, Leonardo Gómez, David Gailán, Yanet Villegas, Andrés Tamayo, Adelma Pérez, Bárbara Pérez, Maylín Lao, Yodelis Calvo, Aneet Fernández, Lianys Lee, Jania Suarez, Judey García, and Eduardo Ojito
Volume 14, Issue 4 (Winter 2015/2016)

Rocker bag bioreactors have been used successfully in cultivating cells because they provide good nutrient distribution and cell suspension while eliminating the need to validate cleaning and sterilization. Therefore, this study examined the long-term performance of a 50 L single-use bag bioreactor on a rocking platform in CB.Hep-1 monoclonal antibody (mAb) production. For such a purpose, the bioreactor was operated in a continuous mode with a mixture of serum-free media (SFM) for 62 days, and with protein-free medium (PFM) for another 62 days. Stationary phase culture results with SFM were: cell concentration of 1.57 ± 0.2 × 106 cells mL-1, specific growth rate of (μ)=0.0202, cell viability of 91.1 ± 6.4%, mAb concentration of 44.6 ± 11.1 μg mL-1, cell-specific secretion of 28.8 ± 8.1 pg cell-1 , and mAb yield of 42.4 ± 4.0 mg L-1. After SFM was replaced by PFM, there were statistically different results (p<0.05) in a cell concentration of 2.56 ± 0.2 × 106 cells mL-1, cell viability of 97.0 ± 1.1%, mAb concentration of 90.1 ± 28.2 μg mL-1, and mAb yield of 76.6 ± 10.6 mg L-1. However, the cell-specific secretion of 38.0 ± 6.0 pg cell-1 was statistically similar, but only with the first batch run with SFM. Average purification recovery from the SFM and PFM supernatants was 74.6 ± 7.9% and 70.9 ± 11.2%, respectively. The recovery and biochemical properties of the CB.Hep-1 mAb cultured with either media composition were similar to those found with CB.Hep-1 mAb produced by ascites. Regardless of whether SFM or PFM is used, it can be concluded that the 50 L single-use bag bioreactor on a rocker platform was suitable for long-term CB.Hep-1 production and can result in a 36 g yield in 125 days...

Citation:
Galván A, Valdés R, González M, Aragón H, Hernández D, Padilla S et al. Long-term CB.Hep-1 monoclonal antibody production in a single-use bioreactor on a rocker platform with serum- and protein-free media. BioProcess J, 2016; 14(4): 4–13. http://dx.doi.org/10.12665/J144.Valdes.

Posted online January 12, 2016.

 
Achieving Excellence in Biopharmaceutical Development and Manufacturing by Using Appropriate Manufacturing Practices (AMPs)

by Mark F. Witcher, PhD
Volume 14, Issue 4 (Winter 2015/2016)

Biopharmaceutical manufacturing will continue to be increasingly challenging as medical knowledge and understanding rapidly advance. Many new therapies and products will utilize cellular, viral, genetic, and epigenetic approaches along with a repertoire of increasingly complex proteins targeting a rapidly increasing inventory of newly discovered biomarkers. Manufacturing these products efficiently, consistently, and reliably will require sophisticated manufacturing approaches, methods, and controls. In addition, growing patient, societal, and even regulatory pressures demand that new therapeutics be developed and manufactured quickly, reliably, and efficiently. Historically, manufacturing has been viewed and managed in terms of minimizing patient safety risks. The focus has been on not harming the patient through inadequate manufacturing practices and controls. This approach is the basis for regulatory defined current good manufacturing practice (cGMP) guidelines that establish minimum standards and practices for regulatory oversight to assure product quality...

Citation:
Witcher MF. Achieving excellence in biopharmaceutical development and manufacturing by using appropriate manufacturing practices (AMPs). BioProcess J, 2016; 14(4): 30–6. http://dx.doi.org/10.12665/J144.Witcher.

Posted online January 12, 2016.

 
A Qualitative Risk-Benefit Structure for Developing and Manufacturing Biopharmaceuticals

by Mark F. Witcher, PhD
Volume 14, Issue 3 (Fall 2015)

Developing and manufacturing biopharmaceuticals is a complex endeavor that will become even more challenging as the field of medicine expands into a broader range of therapies that includes cellular, genetic, epigenetic, and proteins with more specific biomarkers and functions. New manufacturing process technologies utilizing single-use systems, high-performance perfusion bioreactors, and continuous/semi-continuous processing will add further complexity. To better serve the patient population, a biopharmaceutical development and manufacturing enterprise should address all of the patient’s needs. The enterprise must minimize the therapy’s safety risks while providing the benefits of timely, efficient, and reliable access to effective biopharmaceutical products. Achieving the benefits while controlling patient risks can be aided by understanding a qualitative risk-benefit structure that defines the quality of the product in terms of its overall value to the patient. This paper seeks to begin the process of developing a comprehensive risk-benefit structure that can be used by a biopharmaceutical development-manufacturing enterprise to successfully develop and optimize a therapy’s value...

Citation:
Witcher MF. A qualitative risk-benefit structure for developing and manufacturing biopharmaceuticals. BioProcess J, 2015; 14(3): 4–12. http://dx.doi.org/10.12665/J143.Witcher.

Posted online October 9, 2015.

 
Selection of Clarification Methods for Improved Downstream Performance and Economics

by Sarah Le Merdy
Volume 14, Issue 3 (Fall 2015)

The production of biopharmaceutical drugs typically involves a biological expression within a bacterial, yeast, or mammalian cell expansion system. Getting to the final product requires multiple purification steps, from primary clarification to the final formulation and sterile filtration. The aim of the initial purification steps is not to purify the stream perfectly but rather, to prepare the stream for finer and more specific purification steps further downstream. Apart from efficiently removing contaminants, the clarification stages also need to maintain high product recovery whilst being consistent and robust. The finer downstream purification stages represent the largest portion of production costs; and for monoclonal antibodies (MAb), they can represent up to 80% of the overall cost. This cost is, however, heavily impacted by the quality of the feed stream that has been produced. Early clarification and purification steps, although seemingly crude, are critical in removing contaminants and maintaining a cost-effective process further downstream. Selecting them scientifically, based on chosen performance markers, could thus improve the performances of downstream operations. After reviewing the typical feed stream compositions, this article reviews the existing literature and shows the advantages of thoroughly investigating and then selecting a clarification method that provides the best downstream performance and economics...

Citation:
Le Merdy S. Selection of clarification methods for improved downstream performance and economics. BioProcess J, 2015; 14(3): 50–5. http://dx.doi.org/10.12665/J143.LeMerdy.

Posted online October 9, 2015.

 
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