Exciting Trends in Bioprocessing

A White Paper Exclusive
By Alfred Doig and Susan Dana Jones, Ph.D., BioProcess Technology Consultants, Inc.
Getting products onto the market as quickly as possible still remains a key driver in the development of recombinant therapeutic proteins. Any advance in bioprocessing is of particular interest to the industry if it significantly shortens the development timeline or improves the end product. Even better are advances that do both. In the monoclonal antibody (MAb) area, platform processes have enabled companies to standardize on specific mammalian cell lines, transfection approaches, process conditions and downstream processing to shorten the development timeframe.

Access an exclusive white paper to read about several interesting trends in two development areas, which have the potential to shorten the development timeline still further.

Does this topic interest you? If so, we invite you to attend the BioProcess International (BPI) Conference & Exhibition, scheduled for October 26-29, 2015, is the world's largest gathering of bioprocessing and biomanufacturing scientists, executives and technology providers, bringing over 1,600 attendees, 150 exhibitors, 160 speakers and 100 posters to Boston—providing the most effective platform to launch or learn about new products, showcase and evaluate new bioprocess technologies, share and receive input on scientific research and meet the industry's leading innovators in bioprocess development.

BPI covers all phases of bioprocess development including upstream, downstream, analytical, formulation, manufacturing, quality/regulatory and drug product/fill-finish.

» Learn more about the topics that will be presented at BPI

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Why is disposable technology more appealing compared to conventional technology?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he looks at the appeal of disposable technology.

Why is disposable technology more appealing compared to conventional technology?
Continuing from where I left off in my last sentence, as I said if the product has got a long shelf-life, a long demand, that makes sense for us to invest in it and create a good infrastructure, a good footprint and bear the high operational and capital expenditure. But, if the product is in the development phase and you need to have some quick lots of drugs so that we can try clinically, that does not make sense. And, by moving to the disposable technology we are also reducing the chances of cross contamination.

As I said before, again, cleaning, and associated cleaning validation, basically reduced maintenance costs, reduced lead times, increased speed of implementation and time to market , that can be significantly be reduced because we have reduced significantly the time of the processing over the 30 some processes. And we have also reduced the labor costs because of the low cleaning requirement or cleaning validation requirement. And, of course, low space requirement and footprint requirement. That is a main reason why disposable technology is more appealing and more and more people want to go towards that.

In this interview Dr. Shrivastava also discusses disposable membrane chromatography systems, it's cost effectiveness, and how it applies to the large scale.  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.

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Single-Use Applications 2015

Join us for Single-Use Applications 2015 to learn how to optimize time-to-market, overcome complex drug product and manufacturing challenges, and ensure successful implementation and integrity of single-use adoption and deployment.

The event features 10 Case Studies and 2 Interactive Q&A Sessions on Today's Most Pressing Single-Use Challenges including:

• • Ensuring Successful Single-Use Implementation and Integrity: Case Studies from: Amgen and Merck & Co.
• • Single-Use Implementation and Transfer: Case Studies from: Genentech, Merck & Co. and Public Health England
• • BPSA Roundtable: Interactive Q&A: The Road Ahead: Issues Impacting the Accelerated Adoption of Single-Use Technologies
• • Single-Use Considerations for Cell Culture Applications: Case Studies from: NIH and Shire
• • Single-Use Applications in Upstream Processing: Case Studies from: Shire HGT and KPI Biopharma
• • Production and Regulatory Considerations for Single-Use: Case Study from: Protein Sciences Corp.
• • Overcoming Challenges Associate with Particles and Extractables & Leachables: Interactive Q&A: Extractables & Leachables

>> View the Single-Use Agenda
>> View the Full BDP Week Agenda
>> View the Agenda-a-Glance (PDF)

Single-Use Applications 2015 will take place from March 30-31, 2015 in Huntington Beach, CA.  It Flexible Facilities & Biopharmacuetical Development & Production Week is co-located with taking place on March 30 - April 2, 2015.

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Biopharmaceutical Development & Production Week 2015 > Call for Speakers

Biopharmaceutical Development and Production Week 2015 will be the most in-depth and comprehensive concept-to-commercialization experience for professionals dedicated to the advancement of next-generation biologics via manufacturing facilities of the future. And for the first time, BPD Week will also incorporate IBC’s Single-Use Applications and Flexible Facilities conferences into the event. Take a greater role in this community, add to your professional accomplishments, and help shape the future of the field by presenting a talk at BDP Week.

BioPharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.

Speaker proposals are being accepted now through October 27, 2014.
>> Submit your speaking proposal here.

If you are working in any of the following scientific/business topic areas, we encourage you to submit a proposal for a podium presentation. We are especially looking for case studies with unpublished data on the following:

• • Manufacturing Efficiencies: Strategy & Technology
• • Upstream Processing
• • Downstream Processing
• • Antibody Drug Conjugate Development & Production
• • Engineering (Single-Use and Flexible Facilities)
• • Analytical
• • Process Validation
• • Viral Safety
• • Raw Materials and Supply Chain

To go in-depth on what we’re looking for in each of these categories, visit our webpage.

How else can you get involved in BDP Week?

• • We’re also accepting abstracts for posters. Showcase your research by submitting your poster.
• • We’re also currently recruiting sponsors and exhibitors. Each year, BDP Week debuts as the first must attend event for biopharmaceutical professionals from around the globe. Now is the time, to work with IBC to develop a customized, integrated marketing program that features pre-, post- and on-site solutions that help increase your market reach and influence – before, during and after the event. Request more information. 
• • You can also join us as an attendee.  Registration is currently open and you can save up to $450 off the current rate.  

Have any questions? Feel free to reach out Jennifer Pereira.

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Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies.

Enabling Greater Process Control and Higher Protein Titers: Advances in Downstream Single-Use Technologies

Downstream protein purification (the stage in which a protein is isolated and purified) is one of the last steps in biotherapeutic manufacturing. Single-use technologies are an increasingly popular choice for both upstream and downstream bioprocessing because they offer significant benefits over traditional multiuse manufacturing systems. Single-use technologies also provide an array of logistical benefits, including reduced costs, minimized risk of cross-contamination, and improved operational efficiency.

Challenges remain, however, in designing a complete, streamlined, single-use process for downstream protein purification. In-process sensor technologies, chromatography, and temperature control are all areas that have been traditionally underserved by single-use technologies and represent “weak points” in the downstream process flow. Exacerbating the problem, most proteins are heat labile and sensitive to a large number of environmental conditions. Therefore, interruptions in the process and improper temperature management can increase aggregation (which can lead to unstable formulations) or even degradation and denaturation in worst cases.

Read the full article here.


You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.

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Now Available: BDP Week 2014 Conference Brochure

We present the all new Biopharmaceutical Development and Production Week Agenda! This year, the event will take place March 24-27, 2013 in San Diego, California.

It features the most in-depth coverage of BioProcessing topics on the market including: Upstream Processing, Downstream Processing, Analytical Technologies, Viral Safety, Process Validation, Contract Manufacturing, Manufacturing Efficiencies, Supply Chain, Technology Transfer, Raw Materials, Antibody Drug Conjugates

Download the agenda.

What can you look forward to this year?

• - 6 Keynotes
• - 175+Speakers
• - 6 Interactive Discussions
• - 44 Case Studies
• - 59 New Data Presentations
• - 2 Day Training Courses
• - 65+ Exhibitors
• - 80+ Scientific Posters
• - 800+ Attendees
• - BDP Connect, the partnering app that allows to network before, during and after the event
• - Networking Opportunities including Mardi Gras Networking Reception, the BDP Week Beach Party and the Mexican Fiesta Networking Reception

As a reader of this blog, you can take advantage of unpublished rates! They are available until November 1. Simply register to join us and mention code BDP14BLOG to save up to $750 Off the All Access Pass Standard Rate or $450 of the 2 Day Standard Pass Rate. You can also register a team of 4 or more and save 20% off the current rate. The earlier your group registers, the more you save. Contact our group sales representative at 646-895-7445.

Have any questions about this event or how you can get involved? Email Jennifer Pereira.

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BioProcess International presents the Downstream Processing Podcast Series

We are pleased to announce the second series in our 2013 BPI Conference Pre-Event Podcast program. As a reader of this blog, you are granted exclusive access to podcasts recorded by conference keynotes, chair people, session moderators, and speakers who offer their expert perspective and commentary on the scientific trends impacting the bioprocessing industry.

The Downtream Processing Edition previews what you will experience while attending the 2013 BioProcess International Conference & Exhibition taking place at the Hynes Convention Center, Boston MA, September 16-19, 2013.

Download the podcasts.

This month we feature:

• - Audiocast: Downstream Strategies for High-Density Cell Cultures By Dr. Gregory Zarbis-Papastoitsis, Vice President of Process and Manufacturing Sciences at Eleven Biotherapeutics
• - Audiocast: Controlling Process Variability Due to Raw Material Variability By Dave Kolwyck, MS, MBS, Principal Scientist, Amgen
• - Audiocast: Challenges to the Entry of New Biologics into the Market By Joanne T. Beck, Ph.D., Vice President, Process Development, Shire Human Genetic Therapies
• - Audiocast: The BioProcess International Conference & Exhibition: By Barry Walsh and Michael Keenan, Conference Directors, IBC Life Sciences

We also have podcasts featuring our speakers from the Upstream Processing , Manufacturing and Analytical Methods and Instrumentation.

Bioprocess International will take place September 16-19, 2013 in Boston, MA. If you want to know more about these speakers, their presentations and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code BLOG13JP to save 20% off the standard rate!

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Call for Papers: Biopharmaceutical Development & Production (BDP) Week

Announcing IBC’s Annual Conference

Biopharmaceutical Development & Production (BDP) Week

March 24-27, 2014 • Hilton San Diego Bayfront Hotel • San Diego, CA

Now Accepting Speaking Proposals

Deadline to Submit is Friday, August 23rd - Submit Now

Program development is underway for IBC’s Biopharmaceutical Development & Production Week, which is happening March 24-27, 2014, at The Hilton Bayfront Hotel in San Diego, CA.

BDP Week, as it is known throughout the industry, is an event that professionals from every stage of bioprocessing have to come to rely on for new methods to navigate the development, production and regulatory challenges of mAbs and novel molecules.

Whether you are a research scientist or senior level executive, BDP Week is a must-attend calendar event for collective discussion on challenges and insights on the ever-evolving biopharmaceutical development and production sector.

Last February, nearly 1,000 gathered in Huntington Beach, CA, to gain new knowledge, network with industry leaders and discuss the future of bioprocessing. And they will do the same in San Diego in 2014, so why not share your thought leadership?

If you are working in any of the following scientific/business topic areas, we encourage you to submit proposal for a podium presentation. We are especially looking for case studies with unpublished data on the following:

• • ADC Development & Production
• • Antibody Development & Production - Upstream Processing
• • Antibody Development & Production - Downstream Processing
• • Contract Manufacturing & Technology Transfer
• • Analytical Technologies for Biotherapeutic Development
• • Raw Materials
• • Supply Chain Management & Transparency
• • Manufacturing Strategy: Operational Excellence, Business Process/Lifecycle Management
• • Manufacturing Technology Applications: Continuous, Flexible, Automated and Multi-Product
• • Viral Safety and Pathogen Safety for Biologics
• • Process Validation and Continuous Verification
• • Optimizing Properties of Biopharmaceuticals

Review the submission guidelines and to submit a presentation proposal. Deadline to submit is Friday, August 23.

If you would like to submit a proposal, but need an extension or have any topic suggestions, please contact Barry Walsh at 508-614-1464 , Michael Keenan at 949-276-2634 or Mark DeSorbo at 508-614-1405.

If your talk is accepted, you will receive a formal invitation to speak at the conference. This invitation will reflect a deadline for you to send a final presentation title and 60-word abstract. Your abstract and presentation must describe scientific results and must not contain marketing or business development content.

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