Cyber Monday starts early! See details on how you can save on all IIR and IBC Events!

 

To get a head start on the holiday season, as a member of our online community, we’re giving you an extended chance to take advantage of our Cyber Monday sale. Register for the following event and receive 30% off the standard rates. Mention code CYBER2014 when registering for the following:

IBC’s Vaccine Development & Production Summit
December 8-9, 2014 in Boston, MA
Disease and Pandemic Vaccine Research, Discovery and Innovation
More about the event:
Register here.

IBC’s Antibody Engineering & Therapeutics 
December 7-11, 2014 in Huntington Beach, CA
The #1 Forum for Academia and industry to Connect for Scientific Exchange and Networking in Antibody Engineering & Therapeutics, lmmunobiology and Next-Generation Binders
More about the event.
Register here.

IBC’s Commercialization of Cell, Gene & Immunotherapies
December 11-12, 2014 in San Diego, CA
Accelerating the Translation of Commercially Viable Cell, Gene and Immunotherapies Through bioprocess Tools and Technologies
More about the event:
Register here:

IIR’s FDA/CMS Summit for Biopharma Executives
December 11-12, 2014 in Washington, D.C.
Hear about the commercial outlook for biopharma under the new health care exchanges.
More about the event.
Register here.

 IIR’s 19th Annual Drug Delivery Partnerships 
January 29-30, 2015 in Boca Raton, FL.
Accelerating the path to market by leveraging new partnerships, breakthrough innovation and unique business models. Visit the website for full details.
More about the event.
Register here.

IIR’s 12th Annual Medicare Congress
February 3-5, 2015 in New Orleans, LA
Survive the toughest rate environment to date with lessons from top-notch healthcare executives
Visit the website for full details.
Register here.

ePharma **
February 24-26, 2015 in New York, NY
Charge up your marketing campaign with ROI-infused initiatives and embody the newest technologies that bleed success
More about the event.
Register here.

IBC’s Genome Editing Applications
March 18-19, 2015 in Boston, MA
Don't miss out on the only event in the industry focusing on applications of genome editing technologies in research, drug discovery and therapeutic development.
More about the event.
Register here.

IBC’s Biopharmaceutical Development & Production Week (BDP)
IBC’s Single-Use Applications for Biopharmaceutical Manufacturing
IBC’s Flexible Facilities Conference
March 30 – April 1 in Huntington Beach, CA
Create Unique End-to-End Bioprocessing Solutions that Guarantee Reproducible Results and Commercial Manufacturing Success
More about the event.
Register here.

IIR’s 24th Annual Partnerships in Clinical Trials
April 22-24, 2015 in Boston, MA visit the website for full details.
Accelerate speed to market by leveraging new partners, new technologies, and new business models at the must-attend clinical event of the year
More about the event.
Register here.


TIDES
May 3-6, 2015 in San Diego, CA visit the website for full details.
The #1 Industry Forum for CMC, Clinical and Discovery Professionals to Accelerate Oligonucleotide and Peptide Product Development
More about the event.
Register here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid Wednesday, November 26th 2014 through Monday, December 1st  2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.
**Cyber Weekend offer only applicable to registrants not utilizing the Buy One Get One offer. Only pharma/biotech/med device companies are eligible for The Buy One Get Offer

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IBC Life Sciences Announces Plans to Make Biopharmaceutical Development & Production (BDP) Week the Most Comprehensive Concept-to-Commercialization Conference Experience

BDP Week 2015 to incorporate content from these targeted IBC Life Sciences’ conferences: Flexible Facilities, Environmental Monitoring and Contamination Control and Single-Use Applications.


Biopharmaceutical Development & Production (BDP) Week will now be combined with the 12th Annual Single-Use Applications for Biopharmaceutical Manufacturing; 3rd Annual Flexible Facilities; and, 2nd Annual Environmental Monitoring and Contamination Control events. This expanded BDP Week will be held March 30 – April 2, 2015, at the Hyatt Regency Huntington Beach Resort & Spa in Huntington Beach, CA.

The trend in the industry is seeing companies rapidly scaling up toward commercial-scale manufacturing utilizing single-use platforms in more flexible facilities with novel monitoring and control systems. A major contributor to reducing timelines is the integration between process development, analytical and production departments to collectively overcome the complex drug manufacturing challenges to ultimately get these sensitive biologics to market.

“We are reinforcing our manufacturing programming to help companies get out front and master these new industry trends,” says Barry Walsh, Program Director, IBC Life Sciences. “By combining four of our leading biologics events we are creating the most in depth biologics manufacturing event in the industry that will deliver an unrivalled experience. Whether you’re an analytical chemist, head of process development, a manufacturing engineer or quality professional, BDP Week is the premier event to attend focused on all aspects of biologics manufacturing from clinical to commercial.”
Additionally, he said, the co-location makes for an even more productive and comprehensive conference experience for attendees and an increasingly lucrative environment for sponsors and exhibitors.

For more than a decade, BDP Week and its predecessor Antibody Development and Production have provided biopharmaceutical professionals with knowledge they need for development and regulatory landscape navigation from the bench to market. The addition of Single-Use, Flexible Facilities and Environmental Monitoring and Contamination Control not only reinforces BDP Week as the most comprehensive biologics manufacturing event on the market, but also IBC Life Sciences’ commitment to providing its attendees, sponsors and exhibitors with the best possible development opportunities available.

About IBC Life Sciences
IBC Life Sciences, a division of Informa, leads the market by providing quality, expert-led conferences and offering integrated marketing solutions to our customers. Since 1987, the leading pharmaceutical, biotechnology, government and academic organizations have recognized the high quality, in-depth content IBC Life Sciences offers.
Learn more at www.IBCLifeSciences.com.

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Continuous Process Validation at Biogen Idec

Today, we start our preview of the Biopharmaceutical Development and Process Week event.  We had a chance to sit down with many of the speakers presenting at the event.   Today, Greg Stromberg, the Manager of Process Analytics, RTP Manufacturing Sciences, at Biogen Idec gives us an insight into the process validation at Biogen Idec.

From a standpoint of continuous process verification, which is the new FDA paradigm, we are not really new anymore. It's probably two to three years old now. We are working through applying and developing these types of tools at Biogen Idec and we’re honestly trying to lead the industry in it. We have a lot of different modeling tools and a lot of different advance analytics tools and data management tools that we are working to implement all the way from raw material to drug product – specifically in the drug substance world, which is where we are farthest along. We have a lot of structure around the actual compliant data management. And then along those lines we can walk that down into supply and reporting, advance modeling, predictable modeling – basically moving up the pyramid towards parametric release. That’s the dream and vision. 

Currently work is going on in both the drug substance – our large molecule standpoint – but also API and small molecule standpoint. So, that’s currently where we’re working. 

The talk that I plan on going through is covering what we’ve done so far and where we want to go. Obviously, there are always things that you can improve upon. There are obviously things that others are doing in the industry that we’re not and there are other industries that are a lot better at this than we are by automotive industry and chemical industry. So, how do we ensure that our batch processes are in some of our continuous monitoring --- system and monitoring tools? How do we ensure that we meet that need and goal for our business and for our patients?

Greg will be a part of the panel presentation Implication and Impact of Adopting a Lifecycle Concept for Process Validation in the Biopharmaceutical industry.  For more information on this presentation, download the agenda.  If you'd like to join Greg this March 24-27 in San Diego at Biopharmaceutical Development and Process Week, as a reader of this blog when you register to join us and mention code BDP14BLOG and you'll save 20% off the standard rate!

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BioProcess International: Efficient, Flexible Facilities for the 21st Century

Today's author's include: Howard L. Levine, President and Principal Consultant, BioProcess Technology Consultants, Inc., Jan Lilja, Commercial Director, KeyPlants AB, Rick Stock, Consultant, BioProcess Technology Consultants, Inc.; Hans Hummel, Business Development Director, KeyPlants AB, and Susan Dana Jones, VP and Senior Consultant, BioProcess Technology Consultants, Inc.

A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, flexible, biomanufacturing facility construction. The evolution of requirements for biopharmaceutical facilities is driven by globalization of the biopharmaceutical industry, patent expirations of several blockbuster biopharmaceutical products, and the increasing shift in new product development away from blockbuster drugs and toward more personalized, niche products.

An increase in product approvals (primarily monoclonal antibodies, MAbs) and sales growth of 10% per year for the past five years have transformed the biopharmaceutical industry almost exclusively into a “monoclonal antibody industry.” MAb-related products now represent a significant portion of all biopharmaceuticals approved to date and are anticipated to continue to drive future demand for biopharmaceutical manufacturing capacity (1,2,3). Further, as many early MAb products come off patent, the competition to develop and market biosimilar versions of those products is rapidly increasing (4).

Not only are biosimilar sales expected to grow in the US and European markets, but increasing demand for access to affordable biologic products in the emerging markets of Brazil, Russia, India, and China (BRIC) will also stimulate further growth in such sales. Coupled with a desire for local production of critical medicines, the anticipated sales growth will lead to increasing demand for manufacturing facilities that can be installed and operated within those countries. So the need is clear for relatively simple but flexible biomanufacturing facilities that can be easily replicated in multiple locations.

Like all other biopharmaceutical products, MAbs traditionally have been manufactured in large facilities with multiple fixed, stainless steel bioreactors ranging in size from 100 L to 20,000 L; fixed and inflexible downstream processing space; and complex piping for delivery of buffers and media, product transport, and cleaning of the large number of fixed stainless steel tanks and other equipment. Such facilities were oftendesigned to produce a single product each or for campaigning just a few products. But a number of trends are converging to create a demand for smaller, more flexible, and cost-effective manufacturing facility options. Those trends include dramatic increases in product titers and yield, advancements and availability of single-use technologies, pressure to reduce health-care costs, a desire (or in some cases requirement) for local production, and increasing focus on personalized medicine for small niche markets.

You can view the full article here. BPI will be joining us February 10-12 for IBC's 2nd Annual Flexible Facilities Conference taking place in February 24-25 in Berkley, CA. To learn more, view our agenda.

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Call for Posters: Biopharmaceutical Development and Production Week 2014

We invite you to showcase your research and present a poster at IBC’s Biopharmaceutical Development and Production Week event taking place March 24-27, 2014 in San Diego, CA.


Why? Here are just a few of the reasons:

• - Justify Your Trip to BDP Week - presenting a poster at a scientific conferences helps justify the time and cost for you to attend the conference.
• - Share your latest scientific discoveries with the right community- this is your opportunity to offer your experience, expertise and insights to fellow colleagues and potential partners.
• - Gain Recognition - all posters and their presenters will be displayed for all attendees, exhibitors, and presenters to see in the exhibit hall during all networking activities.

The deadline to submission of an abstract is Monday, February 24, 2014. Any registered conference attendee may register to present a poster. To submit a poster, fill out the form here.

Plus, as a reader of this blog, you are eligible to save 20% off the standard rate when you register to attend with priority code BDP14BLOG.*

If you have any questions about submitting a poster or getting involved in the event feel free to email Jennifer Pereira.

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BioProcess International: Sustainability in Bioprocessing

Today we feature an excerpt from an article by Cheryl Scott, Senior Technical Editor of BioProcess International regarding The Sustainability in Bioprocessing.

The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines this concept as “meeting the needs of current generations without compromising the needs of future generations.”

In theory, that may imply an “either–or” situation: That is, either a facility/process is sustainable, or it isn't. (And you could argue, then, that nothing truly is.) But in practice, moving from an unsustainable past toward a sustainable future in business is more of a continuum as companies take steps toward more environmental responsibility over time. Many are beginning to understand that considering the environment doesn't have to add cost; it can improve efficiencies as well as public perceptions by decreasing use of materials and reducing negative environmental impacts, ultimately increasing shareholder value over the long term. Relatively sustainable development can be accomplished by understanding the flow and costs (more than simply financial) of all process inputs and outputs, building systems that can adapt to changing needs, anticipating and managing variability and risk, all while earning a profit. 

Biopharmaceutical manufacturing is no stranger to regulatory concerns. All facilities must at least go through the motions of basic environmental assessment to meet EPA and local requirements. But 21st-century business is placing increased emphasis on sustainability, due not only to public pressure, but also a world of decreasing resources. This special report considers how the bioprocessing industry is beginning to incorporate related ideas into its processes and facilities. What degree of sustainability is realistic to strive for? What hidden costs of not modernizing do companies tend to miss in their evaluations, and what are the real economic advantages of going green? How are companies comparing “apples to oranges” costs of, for example, water for injection (WFI) production and clean/steam-in-place operations with those incurred in securing an uninterrupted source of disposable materials? Where are the tradeoffs specific to various methods of disposal, and how are they to be evaluated? And what lessons can the US biotech industry learn from attention paid to this topic by many European companies and regulatory agencies? 

You can view the full article here.

BPI will be joining us February 24-25 for IBC's 2nd Annual Flexible Facilities event in Berkeley, California. To learn more, download our brochure. Register with code FLEX14BLOG to receive 20% off of the standard rate. We look forward to seeing you this February!

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BDP Week Session Spotlight: Challenges in Incorporating CMOs Into the Supply Chain

Raw materials sourced outside US/Europe and 3rd party manufacturing represent areas of vulnerability in global supply chain. Particularly in outsourced manufacturing, the supply chain is akin to a black box. Control over quality of production and security of raw materials are often lost. Companies need to have more effective communications and closer collaboration with their CMOs and raw material suppliers to maintain supply chain transparency, and ensure the final products reach the patients safely, timely and securely.

At Bioprocessing, Development and Production Week this coming February 25-March 1, 2013, a track will be dedicated to Alliance Integration and Supply Chain Management and will feature the panel presentation Challenges in Incorporating CMOs Into the Supply Chain.  For more information on this track and the rest of the agenda, download the brochure.

Featured Presentation: Challenges in Incorporating CMOs Into the Supply Chain

Panel Moderator: Phil Kaminsky, Ph.D., Professor and Chair, Industrial Engineering and Operations Research,University of California, Berkeley

About the session: Biopharmaceutical firms are increasingly focused on optimizing planning and scheduling in their supply chains, a process that is significantly more complicated if some supply chain steps are outsourced. Building on results of our survey of biopharmaceutical operations managers and our experience working with the members of the UC Berkeley Biopharmaceutical Operations Initiative, we explore how the use of CMOs complicates supply chain planning, scheduling, and optimization, and suggest approaches that have been used to mitigate this additional complexity.

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Business of Biosimilars & Generic Drugs Session Spotlight: The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development

Earlier this month, Biocon announced that it's partnership with Mylan to develop biosimilars could be worth $33 billion.  According to the Economic Times, their partnership was formed in order to develop five biosimilars drugs related to cancer an pain.  This is a similar trend emerging throughout the industry.  At the Business of Biosimilars and Generic Drugs Summit, we'll be looking at the evolving partnerships that are evolving in order to discover and develop biosimilars. For more information about the event, taking place September 10-12 in Boston, MA, download the brochure here.  If you'd like to join us, as a reader of this blog, register and mention code XP1786BLOG to save an exclusive 25% off the standard rate.

Featured Session: The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development

Featured Speaker: Bassil Dahiyat, President and CEO, XENCOR

About the session: What does the recent trend of giant partnerships among biologics and generics companies foretell about the future of the industry? Is this soon to become a standard, and if so, what does your follow-on biologic company need to know and prioritize in order to choose the best partner and structure the strongest, most enduring, and most profi table coalition?

• • Applications for strategic entry into non-U.S. markets
• • Re-envisioning partnerships as a source of process patents to strengthen your product’s life cycle
• • Predict how your patent portfolio can be better protected through market consolidation

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