Welcome!

News Feed Item

Avid Bioservices Highlights Cell Culture Development Expertise at the Well Characterized Biotechnology Pharmaceutical 18th Symposium

A Quality by Design Approach Case Study Demonstrates That Antibody Effector Function Can Be Enhanced by Increasing Afucosylation Levels Simply by Controlling Cell Culture Conditions

TUSTIN, CA -- (Marketwired) -- 01/24/14 -- Avid Bioservices, Inc., a wholly owned subsidiary of Peregrine Pharmaceuticals, Inc., today announced that recent studies demonstrated that it is possible to control key product quality attributes through cell culture conditions. Using Design of Experiments (DoE), the cell culture conditions within the process design space were identified during process understanding and modeling studies that allowed for the control or manipulation of afucosylation (G0) levels. This case study will be presented at the Well Characterized Biotechnology Pharmaceutical (WCBP) 18th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, to be held in Washington, DC, January 27-30, 2014.

Glycosylation is a common posttranslational modification that has shown to be a critical quality attribute (CQA) of recombinant monoclonal antibodies. In particular, the level of afucosylation (for example, G0) is a key glycosylation parameter associated with enhanced antibody activity, for a monoclonal antibody in clinical development.

"By applying a Quality by Design (QbD) approach, we gained a greater insight into how to better control the process, as well as the creation of a clearer blueprint for future development in order to increase our efficiency and, in the end, deliver a more robust process to our clients," said Connie Chang, director of process sciences for Avid Bioservices. "The control of glycosylation and particularly afucosylation is challenging and these results are an important development for this monoclonal antibody. The results from our recent studies show that two Critical Process Parameters significantly affect the afucosylation levels on the antibody. This understanding enabled process modifications within the design space to increase the G0 levels for an existing client cell line. In addition, the increased understanding of process parameters has allowed us to identify additional process controls that allow for more consistent CQAs from batch to batch."

Poster Presentation Details:

Title: "Characterization of Bioreactor Conditions Effect on Afucosylation"
Date: Wednesday, January 29, 2014
Time: 3:15 - 4:15 P.M. EST
Location: Poster Board # P-226-W
Authors: Vince Nguyen, Michael Brown, Roy Sevilla, Aditi Iyengar, Gary Larson, Karyn Pinson, Payam Farahani,
Michael Wang, Calla Montelongo, Olegario Garcia, Mary Wakabayashi, Mary Knauer, Connie Chang

In addition, Avid Bioservices will be hosting conference attendees at booth #19 in the exhibit hall.

For additional information on the WCBP 18th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products, please visit: https://m360.casss.org/event.aspx?eventID=72301

About Avid Bioservices
Avid Bioservices provides a comprehensive range of high quality cGMP manufacturing services for the biotechnology and biopharmaceutical industries to support the manufacture of cGMP clinical phase and commercial products. With over 15 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include GMP clinical and commercial product manufacturing, purification, bulk packaging, final product filling, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line optimization, cell culture and feed optimization, analytical methods development and product characterization. For more information about Avid, please visit www.avidbio.com.

About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative monoclonal antibodies in clinical trials focused on the treatment and diagnosis of cancer. The company is pursuing multiple clinical programs in cancer with its lead immunotherapy candidate bavituximab while seeking a partner to further advance its novel brain cancer agent Cotara®. Peregrine also has in-house cGMP manufacturing capabilities through its wholly-owned subsidiary Avid Bioservices, Inc. (www.avidbio.com), which provides development and biomanufacturing services for both Peregrine and third-party customers. Additional information about Peregrine can be found at www.peregrineinc.com.

Add to Digg Bookmark with del.icio.us Add to Newsvine

Contact:
Chris Keenan or Kelly Pisarev Lord
(800) 987-8256
www.avidbio.com

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
When building large, cloud-based applications that operate at a high scale, it's important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. "Fly two mistakes high" is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Le...
Digital transformation has increased the pace of business creating a productivity divide between the technology haves and have nots. Managing financial information on spreadsheets and piecing together insight from numerous disconnected systems is no longer an option. Rapid market changes and aggressive competition are motivating business leaders to reevaluate legacy technology investments in search of modern technologies to achieve greater agility, reduced costs and organizational efficiencies. ...
Machine learning provides predictive models which a business can apply in countless ways to better understand its customers and operations. Since machine learning was first developed with flat, tabular data in mind, it is still not widely understood: when does it make sense to use graph databases and machine learning in combination? This talk tackles the question from two ends: classifying predictive analytics methods and assessing graph database attributes. It also examines the ongoing lifecycl...
To Really Work for Enterprises, MultiCloud Adoption Requires Far Better and Inclusive Cloud Monitoring and Cost Management … But How? Overwhelmingly, even as enterprises have adopted cloud computing and are expanding to multi-cloud computing, IT leaders remain concerned about how to monitor, manage and control costs across hybrid and multi-cloud deployments. It’s clear that traditional IT monitoring and management approaches, designed after all for on-premises data centers, are falling short in ...
When applications are hosted on servers, they produce immense quantities of logging data. Quality engineers should verify that apps are producing log data that is existent, correct, consumable, and complete. Otherwise, apps in production are not easily monitored, have issues that are difficult to detect, and cannot be corrected quickly. Tom Chavez presents the four steps that quality engineers should include in every test plan for apps that produce log output or other machine data. Learn the ste...
The deluge of IoT sensor data collected from connected devices and the powerful AI required to make that data actionable are giving rise to a hybrid ecosystem in which cloud, on-prem and edge processes become interweaved. Attendees will learn how emerging composable infrastructure solutions deliver the adaptive architecture needed to manage this new data reality. Machine learning algorithms can better anticipate data storms and automate resources to support surges, including fully scalable GPU-c...
A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to great conferences, helping you discover new conferences and increase your return on investment.
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Containers and Kubernetes allow for code portability across on-premise VMs, bare metal, or multiple cloud provider environments. Yet, despite this portability promise, developers may include configuration and application definitions that constrain or even eliminate application portability. In this session we'll describe best practices for "configuration as code" in a Kubernetes environment. We will demonstrate how a properly constructed containerized app can be deployed to both Amazon and Azure ...
Everyone wants the rainbow - reduced IT costs, scalability, continuity, flexibility, manageability, and innovation. But in order to get to that collaboration rainbow, you need the cloud! In this presentation, we'll cover three areas: First - the rainbow of benefits from cloud collaboration. There are many different reasons why more and more companies and institutions are moving to the cloud. Benefits include: cost savings (reducing on-prem infrastructure, reducing data center foot print, redu...
SYS-CON Events announced today that Silicon India has been named “Media Sponsor” of SYS-CON's 21st International Cloud Expo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Published in Silicon Valley, Silicon India magazine is the premiere platform for CIOs to discuss their innovative enterprise solutions and allows IT vendors to learn about new solutions that can help grow their business.
We are seeing a major migration of enterprises applications to the cloud. As cloud and business use of real time applications accelerate, legacy networks are no longer able to architecturally support cloud adoption and deliver the performance and security required by highly distributed enterprises. These outdated solutions have become more costly and complicated to implement, install, manage, and maintain.SD-WAN offers unlimited capabilities for accessing the benefits of the cloud and Internet. ...
You want to start your DevOps journey but where do you begin? Do you say DevOps loudly 5 times while looking in the mirror and it suddenly appears? Do you hire someone? Do you upskill your existing team? Here are some tips to help support your DevOps transformation. Conor Delanbanque has been involved with building & scaling teams in the DevOps space globally. He is the Head of DevOps Practice at MThree Consulting, a global technology consultancy. Conor founded the Future of DevOps Thought Leade...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...