Thursday, October 24, 2013 Daily Archives

Microbial Cultivation In Different Scales in the CELL-tainer® Rocking Single-use Bioreactor

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Single-use bioreactors are applied in the biopharmaceutical industry for mammalian cell culture processes. The low gas-liquid mass transfer coefficient generally achieved in these systems does not allow for the compatable application of microbial processes in these bioreactor systems. The CELL-tainer® technology combines a vertical and horizontal movement in a rocking bioreactor concept, so that the turbulence and power input is intensified. In this system, mass transfer rates comparable to stirred tank reactors are achievable. Thus, volumetric oxygen transfer rates (kLa)…

October 24, 2013

A Systematic Strategy of Cell Culture Media and Feed Development

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Development of a high-performance and robust fed-batch process for recombinant Chinese Hamster Ovary (CHO) cell lines presents challenges in light of the diverse nutritional requirements observed with different clonally derived cell lines as well as the varied production phases. To address these challenges, we will discuss an innovative strategy of media, feed, and process development that has been developed at FUJIFILM Diosynth Biotechnologies (FDB). The efficiency and effectiveness of this strategy have been well demonstrated in multiple mAb-producing CHO cell…

October 24, 2013

Continuous Bioprocessing: A CMO’s Perspective

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The maturation of many process industries is marked by transition from batch to continuous processing. Often this move to con-tinuous processing determines the winners in the industry. Will the bioprocess industry go the same way? The analogy is often drawn to the chemical industry where continuous processing is widely applied. Although available for many decades continuous bioprocessing is not yet a mainstay of the industry. Currently there is a ground swell of feeling within the bioprocess industry that the time…

October 24, 2013

Rapid Antigen Production in Pseudomonas fluorescens Utilizing a High-throughput, Parallel Processing Approach

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Pseudomonas fluorescens, a Gram-negative bacterium, has been specifically developed as a protein production platform to enable rapid identification of strains capable of expressing high titers of soluble and active protein. PfÄ“nex Expression Technology (TM) employs a toolbox of engineered P. fluorescens host strains, including protease deficient mutants and chaperone/ foldase overexpressors combined with a set of expression vectors encoding a variety of transcription and translation regulators, as well as a collection of periplasmic secretion signals. High-throughput automated transformation, growth, and…

October 24, 2013

Next Generation Depth Filters for the Clarification of Flocculated Mammalian Cell Culture

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Increasingly high cell density, high product titer cell cultures, containing mammalian cells are placing a larger burden on traditional downstream clarification and purification operations due to higher product and impurity levels. EMD Millipore has addressed these challenges by developing a proprietary single-use technology to improve primary and secondary direct depth filtration of flocculated high cell density mammalian cell cultures. The use of graded depth filters, combined with pre-treatment technologies, have achieved higher primary throughput capacities and lower flushing volumes as…

October 24, 2013

Liquid-Liquid Porometry of Viresolve® Pro Membrane

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A liquid-liquid porometry (LLP) test was developed to characterize the pore size distribution of Viresolve® Pro membrane. Data generated by this test supports the understanding of the size-based virus removal mechanism of the filter. The LLP test also is used at-line during membrane casting. Process control based on LLP results improves membrane consistency.

October 24, 2013

A Case Study: 3-step Process for Efficient mAb Purification

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This study showcases a portfolio of commercially available biopharmaceutical chromatography resins designed for the efficient purification of monoclonal antibodies. A 3-step purification process has been implemented which showed effective removal of the main contaminants, low ligand leakage, and high yields over the entire process. Eshmuno® A affinity chromatography resin was evaluated as the first step in the process. The Protein A elution pool was further purified using cation exchange chromatography. Two cation exchange resins with different selectivities were compared. The…

October 24, 2013

Scalable Method for Packing Chromatography Columns

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Currently the bio-pharmaceutical industry is heading towards cost cutting, time saving and single use manufacturing approach. This has opened up a whole new market for disposable technologies. Pre-packed disposable chromatography columns are a best fit for preclinical and clinical stage Monoclonal Antibody (mAb) production and vaccine manufacturing processes which require quick turnaround times and aggressive validation respectively. This work describes development of pre-packed and ready to use chromatography columns to meet this need in the industry. A robust packing method…

October 24, 2013

Platform Purification of a Domain Antibody

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Monoclonal antibodies (MAbs) are very successful for treatment of several different cancers and tumors. However, the low tissue penetration has led to the development of smaller sized biopharmaceuticals (Ab fragments) such as Fabs, single chain Fv (scFv) and domain antibodies (Dabs). These molecules lack the Fc part of the antibody making a platform purification approach using Protein A impossible. However, with the introduction of the Protein L based affinity chromatography media (Captoâ„¢ L) new possibilities are introduced for capture of…

October 24, 2013

Progress On A Fully Disposable Downstream Platform: A Simple, Risk-Free, Plug-in Solution To Solve The DSP Bottleneck

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Natrix HD Membrane technology features a polymeric hydrogel formed within a flexible porous support matrix. The support matrix provides mechanical strength, while the hydrogel properties determine the separation chemistry of the product. An advantage of the Natrix chemistry is the ability to place virtually any functional group chemistry throughout the hydrogel polymer. Natrix HD membrane technology combines the superior binding capacity of conventional resinbased columns with the high throughput of membranes in a single-use format that eliminates costly packing, cleaning,…

October 24, 2013