BioProcess International Poster Preview: Seg-Flow® Automated Nutrient Monitoring and Continuous Feed Platform for Precise Nutrient Feed Control

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2015 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Seg-Flow® Automated Nutrient Monitoring and Continuous Feed Platform for Precise Nutrient Feed Control

Presenter: Ashley Fisher, Flownamics, Inc.

About: Fed-batch culture processes are commonly used for the production of various biotherapeutic and other industrial commodities. A widely employed nutrient feed control strategy for both cell culture and microbial fermentation processes is direct feedback control, in which the nutrient feed is directly controlled by the nutrient, i.e., glucose, concentration. However, various iterations of this feeding approach exist which may not be conducive to culture growth and productivity. In order to optimize culture performance, the means by which the substrate is fed to the culture is just as, if not more, important as maintaining the desired media substrate levels. An automated feedback control platform, which employs a continuous feed strategy based on the culture’s real-time nutrient consumption rate, has been developed by Flownamics®. This integrated platform consists of the Seg-Flow® automated on-line sampling system, a nutrient analyzer and a feed pump. The Seg-Flow system was evaluated for its ability to precisely control media glucose concentrations in both low and high consumption rate culture simulation models. The results showed that the integrated Seg-Flow system was able to precisely control media glucose concentrations at the prescribed levels through real-time glucose consumption rate calculation and continuous feeding.

Can't make it to  Boston for the whole event but still want to browse the Exhibit Hall and check out the BPI Innovation Theater?  You can join us with an Exhibit Hall and Keynote Pass!  Find out more and register here.

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BioProcess International Poster Preview: Direct Quantification of Residual Host Cell DNA

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2015 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Direct Quantification of Residual Host Cell DNA

Presenter: Nancy Ngo, Bio-Rad Laboratories

About: Many therapeutic proteins and vaccines are manufactured using bacterial and mammalian host cells. Manufacturing processes are prone to leaving biological impurities from these cells, such as host cell DNA (HCD). The presence of HCD in drug substances poses safety concerns and must be removed to ensure product quality and safety. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO), have provided guidelines defining acceptable levels of HCD allowed in final drug products; the upper limit is 100 pg/dose and 10 ng/dose as stated by the FDA and WHO, respectively. Therefore, the method to quantify residual HCD and monitor DNA clearance should be highly sensitive to meet these regulatory requirements. Here, we introduce a highly precise and sensitive method for residual HCD quantification, without the need for DNA extraction, using droplet digital PCR (ddPCR). We created a panel of test matrices to simulate various process intermediates and analyzed these samples using ddPCR. Spiked-in DNA can be fully recovered even in complex matrices with high precision and femtogram-level sensitivity. The results from our study clearly show the effectiveness of ddPCR in detecting residual HCD by a direct method and without the need for DNA extraction.

Can't make it to  Boston for the whole event but still want to browse the Exhibit Hall and check out the BPI Innovation Theater?  You can join us with an Exhibit Hall and Keynote Pass!  Find out more and register here.

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BioProcess International Poster Preview: The Renaissance of Expanded Bed Adsorption?

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2015 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: The Renaissance of Expanded Bed Adsorption?

Presenter: Martin Hoffman, Biotechflow

About: 20 years after development, Expanded Bed Adsorption chromatography fell out of favour in Bioprocessing. Proposed improvements in process efficiency- obtaining high yields from unclarified feed stocks- were compromised by column design and process run failures; in part caused by blocked meshes, lipid breakthrough and demand for high buffer volumes producing high eluting volume. Current media optimize Dynamic Binding Capacity within the expanded bed. Coupled with improved inlet design, increased bed densities are achieved, which permit high flow rates (450 cm/hr) and throughputs. Direct product capture reduces unit costs by 66%, and labour cost and process time. Comparisons with packed bed chromatography result in higher product yield and 43% reduction in buffer volume. Fully-scalable, cGMP EBA column design improvements prevent vortex formation, whilst ultrasound technology enables contactless monitoring of process dynamics and flow rate via feedback to the skid; both factors maximize expanded bed stability. Reduced column footprint and height requirements increase versatility. In recent years, step changes in incubation techniques, media design, column technology and sensor applications have enabled proven improvements in EBA process efficiency and operations. The initial promise may now be considered as surpassed, and a renaissance of Expanded Bed Adsorption Chromatography should be proposed.

Can't make it to  Boston for the whole event but still want to browse the Exhibit Hall and check out the BPI Innovation Theater?  You can join us with an Exhibit Hall and Keynote Pass!  Find out more and register here.

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Now Available: 2014 BioProcess International Conference Brochure

IBC's BioProcess International Conference & Exhibition Conference

October 20-23, 2014 | Exhibition: October 21-23, 2014

Hynes Convention Center - Boston, MA

Download the Complete Brochure Today

BioProcess International is where industry connects to share technical, scientific and strategic innovations across all phases of bioprocess development: Upstream, Downstream, Formulation & Delivery, Manufacturing, Analytical and Quality.

This year's featured 2014 keynote:

• Enabling Delivery of a Novel Pipeline
• >John G. Cox, Executive Vice President of Pharmaceutical, Operations & Technology, Biogen Idec
• Delivering Innovation in Biotherapeutic Manufacturing
• >Ralph Lambalot Ph.D., Vice President, Biologics Development, AbbVie
• Keeping the Patient’s and Caregiver’s Experience in Mind
• >Robert Mattaliano, Ph.D., Vice President and Deputy Head of Global, Biotherapeutics Development, Sanofi R&D
• Biologically-derived Medicines on Demand for Battlefield Medicine
• >Geoffrey Ling, M.D., Ph.D., Director, Biological Technologies Office, DARPA
• Complexity in Biological Systems & Big Data Analytics
• >Ganesh V. Kaundinya, Ph.D., Co-Founder and Chief Scientific Officer, Momenta Pharmaceuticals

Make plans now to join us in Boston to find new ideas and make new contacts to help you
meet the demands of diverse product portfolios in an evolving biomanufacturing landscape.  Register to join us in Boston before Friday, May 23 to save up to $600 off the standard rate.  Have any questions or want to get involved?  Email Jennifer Pereira.

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