Author Archives: BPI Contributor

Reducing the Host Cell DNA Quantitation Bottleneck: Approaches for Improved Sample Preparation and Throughput

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The removal of impurities arising from host cells used for the production of biopharmaceutical products is a crucial step in the purification process. Regulatory guidance for products produced in cell culture specifies that residual host cell DNA content in the final product should be as low as possible. Because of the low sample throughput typical of most quantitative DNA assays, host-cell DNA quantitation can become an analytical bottleneck during process characterization.

In this webcast, speakers will discuss a qPCR-based system for highly sensitive, accurate quantitation of residual host-cell DNA from a variety of cellular production systems, including Chinese Hamster Ovary (CHO), E. coli and Vero cells. Case studies will be presented that demonstrate DNA recovery from highly complex test sample matrices, typical of those in biopharmaceutical manufacturing environments. Options for automated sample preparation, testing results from samples typical of a monoclonal antibody purification process and results from an external validation study, executed according to ICH guidelines, will also be reviewed.

July 1, 2014

TOYOPEARL NH2-750F Aggregate Removal from Monoclonal Antibodies

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The drive to reduce the manufacturing costs for biological therapeutics have increased the demands placed on downstream unit operations to the point where a single processing step is expected to accomplish a multitude of purification objectives. Where anion exchange resins have traditionally been used to remove DNA, endotoxin, and as a viral clearance step in the purification of monoclonal antibodies (mAbs), new ligand chemistries make it possible for anion exchange chromatography to do more. In the following paper, TOYOPEARL NH2-750F,…

June 23, 2014

Rapid Micro Biosystems announces the commercial availability of The Growth Directâ„¢ System for Environmental Monitoring and Bioburden Applications

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Rapid Micro Biosystems Bedford, MA (June 9, 2014) – Rapid Micro Biosystems, the provider of automated, rapid, non-destructive detection and enumeration technologies in microbiology, today announced the launch of the next generation of Growth Directâ„¢ System and accompanying applications. The Growth Directâ„¢ System is designed to automate the incubation, detection, enumeration and reporting steps for environmental monitoring and bioburden applications in pharmaceutical quality control laboratories. The technology is based on the detection of the natural auto-fluorescence of microorganisms; requiring no…

June 9, 2014

Repligen Acquires Bioprocessing Business of Refine Technology

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Repligen Corporation WALTHAM, Mass., – Repligen Corporation (Nasdaq:RGEN) announced today that it has acquired the business of Refine Technology (“Refine”), including Refine’s Alternating Tangential Flow (“ATF”) System, a market-leading device used to significantly increase product yield during the fermentation step of the biologic drug manufacturing process. The acquisition strengthens Repligen’s bioprocessing business by adding a profitable and highly complementary product line while expanding the Company’s direct sales presence worldwide. Repligen has entered into a definitive agreement effective June 2, 2014…

June 3, 2014

Sartorius Stedim Biotech launches new single-use bag family Flexsafe

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Sartorius Stedim Biotech Goettingen, Germany | Aubagne, France – Sartorius Stedim Biotech, a leading global supplier of the biopharmaceutical industry, is introducing a brand-new, scalable range of single-use bags. Its completely new developed product family Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film. The innovative concept of the Flexsafe family addresses key industry requirements for future-proof single-use…

June 2, 2014

One Billion Mesenchymal Stem Cells in Eppendorf BioBLU 5c Single-Use Bioreactor at 3L Scale

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This webcast features: Ma Sha This Ask the Expert webcast features Dr. Ma Sha, Director of Technical Applications for Eppendorf, Inc. In this webcast, presented to a live audience on May 6, 2014, he demonstrated the success of large clinical-scale culture of human adipose-derived mesenchymal stem cells (AdMSCs) in a BioBLU 5c single-use bioreactor at 3L scale. You can view the webcast here (Registration Required) Link to paper mentioned in presentation: A Novel Method for the Expansion of Mesenchymal Stem…

June 1, 2014

Natrix Separations Names Peter Tunon Vice President of Sales and Marketing

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Natrix Separations Burlington, Ontario, May 22, 2014 — Natrix Separations, Inc., a maker of innovative single-use chromatography products for the biopharmaceutical industry, announced today that Peter Tunon has joined the company as Vice President of Sales & Marketing. In this role, Mr. Tunon will lead all commercial activities for Natrix, including marketing, product management, channel strategy, sales support for channel partners, and business development. A native of Uppsala, Sweden, Mr. Tunon brings over 25 years of professional experience in general…

May 22, 2014

EMD Millipore Expands Provantage® Upstream Bioproduction Services to the North American Market

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EMD Millipore May 5, 2014, Billerica, MA — EMD Millipore, the life science division of Merck KGaA of Darmstadt, Germany, today announces the expansion of its upstream services into North America as part of its Provantage® Biodevelopment and Clinical Supply offering. The company’s Massachusetts facilities will now offer upstream capabilities including media and feed screening, small-scale material production, and optimization of conditions for scale-up and technology transfer. This expansion allows EMD Millipore’s North American customers to access the same services…

May 5, 2014