Flexible Facilities 2015

Get a comprehensive look at the flexible, multiproduct centric, biomanufacturing landscape from senior level executives and scientists from biopharmaceutical firms, CMOs, technology providers, engineering firms and regulatory groups. Explore the evolving biomanufacturing landscape and beyond through shared case studies on flexible facility implementations, lessons learned and practical experience.

• • Non-Classified, Closed and Other Considerations and for Single-Use Implementation
• • Process and Facility Design Strategies and Considerations
• • Process Development and Manufacturing Strategies
• • Design, Management and Implementation Considerations for Flexible Facilities
• • BPOG Session
• • Biomanufacturing of the Future

Plus, our speaker list features experts from: Shire, Sanofi Pasteur, EMD Millipore, Texas A&M Center for Innovation in Advanced Development and Manufacturing, Genentech, Development & Production, Public Health England, NNE Pharmaplan, University of Massachusetts Medical School, Biogen Idec, BPOG, GSK Biologicals and more!

>> View the Flexible Facilities Agenda
>> View the Full BDP Week Agenda
>> View the Agenda-a-Glance (PDF)

This event is co-located with Single-Use Applications & Biopharmacuetical Development & Production Week taking place on March 30 - April 2, 2015.  As a reader of blog, when you register to join us and mention code XB15155BLOGJP and save 20% off the current rates!

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Highlights from the Flexible Facilities Podcast Featuring Adam Goldstein

Today's podcast features Adam Goldstein, Principal Scientist, Global Manufacturing Sciences, Genentech.Goldstein discussed the implementation of single-use technologies for biotech, unit operations, and new applications. Check out our highlights below:


Single-use technologies show their benefit in the workplace for biotech. What are some of the biggest concerns for implementation?

Adam: Some of the biggest concerns are actually quite varied. While single-use technologies have been well adopted over the last several years, as they grow in their varied uses in upstream and downstream and now gaining dramatic popularity in drug products as far as disposable fill systems go, there are a couple of different issues or concerns for implementation – a couple that are well known, such as extractables and leachables. While we believe we have a good handle on extractables leachables, which many companies have their own program for determining what those acceptable limits or values may be and/or risk assessments are capable of managing, as we are continuing to use the disposables and unit operations, there are some surprising side effects of our findings that are directly from leachables – from the process.

What are some of the newer innovations you’ve seen coming out to the marketplace? 

Adam: Some of the newer innovations that I continue to see innovate that are particularly close to me in the work that I’m working on that I will probably review with you on the talk will be bulk freeze applications. So, there are a number of new applications coming out that are having end-to-end solutions from small scale, somewhere around 1 to 2 to 5 liter freezes up to 12, 16, 20 liter freezes and now up to 300 liter freezes in a disposable bulk-free system. Those innovations, while novel, also are not without their risks and we can review some of those risks as well, during the talk.

Download the full podcast.

Join Adam February 24-25 at IBC's 2nd annual Flexible Facilities. To learn more, download our brochure. Register with code FLEX14BLOG and save 20% off of the standard rate. We hope to see you in Berkeley, CA!

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Flexible Facilities: The New Wave of Flexible Biomanufacturing Solutions

IBC’s 2014 Flexible Facilities is your chance to join thought-leaders from biopharma companies, technology providers, CMO's, engineering firms and regulatory groups who will discuss best practices, potential hurdles and creative solutions for the new wave of flexible biomanufacturing solutions that are beginning to emerge. 

LEARN about Novel Facility Design Concepts 

• 100% disposable and hybrid facilities 

• Retrofitting stainless steel to be more flexible 

• Modular systems and plug & play designs 

• Multi-product facilities, open ballrooms and closed systems 

DISCOVER How BARDA and the DOD are Developing Flexible Facilities 

• Emergent’s flexible manufacturing capabilities and facilities 

• Novartis Vaccines and the Holly Springs manufacturing site 

• Kalon Therapeutics and Texas A&M University’s Collaboration 

• Nanotherapeutics flexible manufacturing for Medical Countermeasures 

HEAR about Practical Experiences in Single-use Implementation 

• Single-use in vaccine upstream processes 

• Case study comparing a single use mAb process to a stainless steel process 

• Functionally-closed systems and multi-product facilities 

PREPARE Yourself for Rapid Deployment and Emerging Market Opportunities 

• Biosimilars, flexible systems and emerging markets 

• Establishing manufacturing capacity in BRIC regions 

• Production strategies for pandemics and biothreats 

To learn more, download our full agenda.

Register with priority code FLEX14BLOG to save 20% off of our standard rate. If you have questions about the event, feel free to contact our group manager, Kate Devery (Kdevery@iirusa.com), or visit our webpage. We look forward to seeing you February 24-25 in Berkeley, California! 

Cheers, 

The Flexible Facilities Team 

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Biopharma's Flexible Imperative

Today, we feature an excerpt from our partners at Pharmaceutical Manufacturing's eBook Biopharmaceutical Manufacturing Trends 2013 Excellence Within a Rapidly Changing Landscape.  Download the full eBook here.  They will be joining us at Biopharmaceutical Development and Manufacturing Week this March 24-28, 2013 in San Diego, California.

Biopharma's Flexible Imperative

Recently, a number of different trends have converged to demand a new type of biopharmaceutical facility, one that emphasizes flexibility and agility. Drawing this new blueprint are:

• -Business needs to minimize time lines and financial risks
• -"Biotech on Demand" and the ability to shore up local manufacturing capacity, quickly, to meet market needs;
• -National security needs for systems that can easily and rapidly respond to biological attacks;
• -Urgent national health needs to protect the public from large-scale, fast moving epidemics and pandemics

Today's biopharmaceutical manufacturing facilities are smaller and more flexible, efficient and cost-effective than those of the 1990s and the are able to adapt quickly to market changes.   

The goal isn't technology in an dof itself, but greater product and process know-how for speed to market.  With modular systems, we can now place an entire small-scale clinical production line inside an 18'x42'x13' (W x L x H) environment.

Download the Biopharmaceutical Manufacturing Trends 2013 eBook here.

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Session Spotlight: Flexible Facilities Democratization of Biosimilars' Opportunity in Emerging Markets

By their very nature, the emerging wave of new flexible facilities encompassing the use of single use technologies and modular/mobile production components, are enabling companies to think about bioproduction in ways they never have before. The cost, complexity and logistics of building a traditional stainless steel facility in an emerging region, like BRIC countries for examples is tremendous. However, with new flexible technologies and facilities – building a much smaller and more nimble facility within an emerging region is now within region. So how do you identify factors and effective strategies for successful entry? 

Session: Flexible Facilities Democratization of Biosimilars' Opportunity in Emerging Markets 

Speaker: Abdullah Baaj, M.D., PharmD, CEO, Boston Oncology  

As far as new products like biosimilars, which rely on a very low cost of manufacturing in order to be competitive, flexible facilities and technologies are lowering manufacturing costs. Want to learn more about biomanufacturing options for production of biosimilars in emerging markets? Join us February 24-25, 2014 in Berkley, CA for IBC's 2nd Annual Flexible Facilities conference.  

To view our full program, download our agenda. Use code FLEX14BLOG to  receive 20% off of the standard rate when you register. We hope to see you this February! 

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Engineering & Design Strategies to Enable Flexible Facilities

IBC’s Flexible Facilities Conference is your chance to join other thought-leaders from biopharma companies, technology providers, CMO's, engineering firms and regulatory groups who will discuss best practices, potential hurdles and creative solutions for the new wave of flexible biomanufacturing solutions that are beginning to emerge. 

Check out our highlights from the 2014 brochure: 

• Reinventing Biomanufacturing: Case Studies of Flexible Facilities; Multi-product Vaccine Facility – Benefits and Challenges Niels Guldager, Senior Technology Partner, NNE Pharmaplan, Denmark Klaus Hermansen, Senior Technology Partner, NNE Pharmaplan, Denmark 

• Case Study: Facility of the Future – Single Use Facility Chien Lin, Senior Manager, Process Engineering, Global Project Engineering, Biogen Idec, Inc. 

• Development Pilot Plant Design and Considerations for Vaccine and Cell Therapy Projects Paul Ko, Ph.D., Senior Scientist, Janssen Research & Development 

• Flexible Supply Chain – A Complement to Flexible Facility Operations Eric Hanson, Senior Manager, Facilities & Operations, Gilead Sciences, Inc. 

• The Flexible Factory is Not Just a Room Full of Bags! Marc Pelletier, Ph.D., Director of Biotechnology, CRB Consulting Engineers 

Want to learn more? Download our agenda.

Register with priority code FLEX14JP to save 20% off of our standard rate. If you have questions about the event, feel free to contact Kate Devery (Kdevery@iirusa.com), or visit our webpage. We look forward to seeing you February 24-25 in Berkeley, California! 

Cheers, 

The Future of Biopharma Team 

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Biopharmaceutical Pipelines and Facility Needs are Changing… Are You Prepared?

IBC's 2nd Annual Flexible Facilities conference brings together senior level executives and scientists from biopharmas, CMO's, technology providers, engineering firms and regulatory groups to explore the changing landscape of biologics manufacturing and to share case studies of the latest flexible facility implementations, lessons learned and practical experiences.

Prepare Your Facilities and Bioprocesses for a Changing Market: 

• Rapid Deployment/Emerging Regions
• More Complex & Diverse Molecules
• Facility Designs to Save Time and money
• Make Stainless Steel More Flexible
• Implementation of Single-Use
• Mobile and Modular Concepts
• Multi-product/Multi-use Facilities
• Regulatory Views & Technology Gaps

To learn more, download the 2014 brochure.

This event sold out last year. If you are interested in attending, you can take advantage of the lowest rates available – this is a $600 standard rate savings when you register by November 15 with priority code FLEX14LA1. For any additional questions, visit our website:

If you have questions about the event, contact Kate Devery (Kdevery@iirusa.com), or visit our webpage. We look forward to seeing you February 24-25 in Berkeley, California!

Cheers,
The Future of Biopharma Team

Flexible Facilities Webpage
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Flexible Facilities 2014: Call for Speakers/Mark Your Calendar

Flexible Facilities

Innovative Biopharmaceutical Manufacturing Solutions for Multi-Product Pipelines,

Global Markets, On-Demand Scale-up/Scale-Down and Capacity Optimization

February 24-25, 2014 • The Claremont Hotel & Spa • Berkeley, CA

IBC’s Flexible Facilities conference will bring together senior level VPs, directors, managers, group leaders and scientists involved in manufacturing, technical operations, process development, engineering, regulatory and quality to discuss the strategic, technical, economic and regulatory/quality considerations necessary for implementation of more flexible, modular or multi-product biomanufacturing facilities throughout the world. Thought-leaders from biopharma companies, technology providers, CMO’s and engineering firms will discuss the latest facility designs, evaluate existing and future technology needs and share potential hurdles and creative solutions regarding the new wave of flexible biomanufacturing options that continue to emerge. This conference will also emphasize case studies of lessons learned and practical experiences by companies who have implemented flexible technologies and flexible facilities.

Call for Speakers
We Are Currently Accepting Proposals for Speaker Presentations: To submit a proposal, you will be asked to select the conference topic you are interested in presenting, provide a 100-150 word summary of your proposed talk by Friday, August 30 and provide your full contact details.

We are looking for presentations in the following topic areas:

• • Novel Facility Design Concepts (Open Ballroom, Modular, Hybrid, Plug and Play, Single Use)
• • Case Studies of Making Stainless Steel Facilities More Flexible/Retrofitting
• • Economic Analyses and Quality Risks of Flexible Biomanufacturing vs. Stainless Steel
• • Regulatory Perspectives on Flexible Facilities and Technologies in Clinical and Commercial Scale
• • Practical Experiences and Challenges Implementing Single Use in a Facility
• • Case Studies of Implementing a Flexible Facility at Commercial Scale
• • Implementation Case Studies of (Dual Trains, Multi-Products, 2 Different Cell Lines, Concurrent Viral and Bacterial, etc.)
• • Case Studies of Multi-Product Facilities (Nuts and Bolts , Cleaning, Changeover, Gowning)
• • Implementations of Continuous Manufacturing and Closed Systems
• • Case Studies of Implementing Flexible Facilities for Emerging Markets – Lessons Learned
• • Case Studies that Highlight Gaps in Existing Technologies – What Technologies Need to be Improved to Enable Flexible Facilities?
• • Case Studies of Implementing Automation and Data Management Systems in Flexible Facilities

Click here for a complete list of topics or to submit.

Proposals will be selected for oral presentations based on evidence in the abstract showing a concrete case study, technology implementation or practical application/technique. All speaker submissions should be received by Friday, August 30, 2013.

Sponsorships and Exhibits – Reserve Your Booth Today
If you are a biopharma CMO, engineering firm or technology provider working in single use/disposables, modular systems, plug and play technologies, facility automation, manufacturing execution systems (MES), control systems, data management/visualization and related technologies, you can not afford to miss this event. The biopharma thought-leaders who make facility-related technology and outsourcing decisions will be attending this conference. Reserve your exhibit booth today or contact us to find out about other opportunities to promote your product or service at this event through sponsorships and other marketing opportunities.For more information, please contact: Sherry Johnson at sjohnson@ibcusa.com or 508-614-1451

Thank you for your interest in IBC’s Flexible Facilities conference. Please don’t hesitate to contact me at jpereira@iirusa.com if you have any questions about the program.

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BioProcess International Session Spotlight: Facility of the Future – Single Use Facility, A Case Study from Biogen Idec

Single Use technologies have become widely deployed in bioprocessing and biopharmaceutical manufacturing for various applications. However, there are still a number of applications where single use technologies are not being used that offer opportunities for increase efficiency. Much more is being learned as companies test out disposable technologies and a number of practical challenges are being discovered.

This week, we profile the session Facility of the Future – Single Use Facility, A Case Study from Biogen Idec.  This session will highlight the practical experiences and lessons learned by companies who are actively trying to exploit single use technologies in their facilities and bioprocess operations. You will learn unbiased opinions about what works, what doesn’t and improvements that still need to be made to better incorporate this exciting technology for maximum benefit.

The BioProcess International Conference will take place September 16-19, 2013 in Boston, MA.  For more information on this session and the rest of the program, download the agenda.  If you'd like to join us, as a reader of this blog when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate.

Featured Session: Facility of the Future – Single Use Facility, A Case Study from Biogen Idec

Featured Speaker: Chien Lin, Senior Manager, Process Engineering, Global Project Engineering, Biogen Idec, Inc.

About the Session:  In 2012, Biogen Idec completed its first single use disposable manufacturing facility named FVM (Flexible Volume Manufacturing). This new manufacturing facility incorporated many innovative designs and seamlessly integrates operations into its existing facility in RTP (Research Triangle Park). This case study will highlight some of the design feature and intent, compare the cost of construction of this facility versus comparable traditional stainless steel facility, and finally some lessons learned from its first campaign.

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The benefits of flexible facilities

In a recent article at Pharmaceutical Manufacturing, Eric Unrau, Director of International Operations for CRB Consulting Engineers, sat down to talk some of the benefits of the new trend of creating flexible facilities when developing manufacturing facilities for pharmaceutical products.  The facilities are specifically created for the drug being made and at the requests of the Pharma companies which leads to reduced investments and faster schedules.  Due to the designed production equipment for the pharmaceuticals, product quality rises as well as a reduced risk for patients and regulatory.  When creating the facilities, CRB Consulting Engineers consider technologies, business drivers, design, quality, maintenance, safety, environmental and operations initiatives.  In the article, they take a look at how Shire pushed this envelope on taking advantage of these technologies.Read it here.

This fall at the BioProcess International Event taking place September 16-19, 2013, we'll be bringing companies including Biogen Idec, CMC Icos Biologics, Pall Life Sciencs and more together to share their insights on Flexible Facilities, Multi-product Manufacturing and Single-Use Implementation: Practical Experiences and Lessons Learned.  For more information on these sessions and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code BPI13BLOG, you'll save 20% off the standard rate!

Do you think flexible facilities will help more pharma companies move into faster production timelines?

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Flex Facilities Session Spotlight: Flex Facilities: Flexible Bioproduction Strategies for Vaccines, Pandemics and Biothreats

Having the ability to ramp up or down production of a biological or vaccine on demand is of great interest to biomanufacturing companies. The flexibility this provides in the case of a sharp increase or decrease in demand of your vaccine decreases the overall project risk. And in the case of a pandemic or biothreat, having the ability to quickly manufacture an agent to counteract these situations can have a huge benefit in saving lives. Next week at the Flexible Facilities event, several sessions will focus on Flex Facilities: Flexible Bioproduction Strategies for Vaccines, Pandemics and Biothreats.  They will describe the flexible bioproduction factories emerging around the world that offer these capabilities.

Flexible Facilities will take place next week, April 2-4, 2013 in San Francisco, California.  For more information on this event, download the agenda.  If you'd like to join us, as a reader of this blog, mention code FF13JP when you register and you'll save 20% off the standard rate.

Featured session: Increasing Flexibility in Vaccine Manufacturing Processes and Facilities with Disposable/Single-Use Technologies

Featured Speaker: Tony D’Amore, Ph.D., Vice President, Bioprocess Research & Development, North America, Sanofi Pasteur, Canada

About the session: This presentation discusses specific examples of the use of single-use disposable technologies in the downstream purification and the formulation and filling of our vaccine clinical products. In addition to increasing the speed of process development, single-use disposable technologies are less technically complex, have lower investment costs and offer a wide variety of flexibility and ease in facility change-over.


Featured Session: Case Study of a Flexible, Multi-Product Vaccine Facility: Medigen, Taiwan

Featured Speakers: Niels Guldager, Senior Technology Partner, NNE Pharmaplan, Denmark
Klaus Hermansen, Senior Technology Partner, NNE Pharmaplan, Denmark

About the session: Medigen is a company that is planning to produce a number of different vaccine products in a new green field facility in Taipei, Taiwan.

This case study discusses:

• - Level of flexibility required for two production lines
• - Changeover from BSL2 to non-BSL functions of various process areas
• - Uni-directional flow as a tool for process segregation; Modular versus nonmodular facility design
• - Manufacturing logistic challenges by operation in a multi-product facility

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Flexible manufacturing moves beyond single use systems

Functioning flexible facilities have moved beyond just manufacturing for single use systems.  It's every company's goal to become agile with their flexible facilities and keep up to date with structural designs, staffing models and updated technology.  In the article from BPI Magazine entitled Vendor Voices: Flexible Manufacturing by Maribel Rios she looks at the current strategies going into flexible facilities and how they are improving the manufacturing process for Pharma.

Here is an excerpt: 

Using a facility for manufacturing multiple products, even at various phases in development, is one way major Bonham-Carter (vice president of sales and business development at Refine Technology), two major factors are driving this trend. First, increasing market pressure to compete with future biosimilars is forcing companies to reexamine costs. “Many big pharmaceutical companies have biosimilar programs, so when they are looking at a new manufacturing facility for these they need to look at costs. They don’t want the facility to be just about one product as well. There is no point in taking forward an old or inefficient technology that worked well 10 years ago for your best-in-class drug, your unique drug. You want to have today’s advanced and cost-saving technologies instead — and they might well be used for improving an old facility too.” The second push is the presence of multiple drugs for the same indication. “A multibillion-dollar market might have to be shared three, four, or five ways. That means your cost of manufacturing, which might not have been critically important previously, is now important. It could even be a competitive selling point in the market. It’s really a question of, when examining your future production requirements: Can you build a cheaper, smaller, and more flexible facility that can handle different drug products with different production needs? The new technology available today has reduced the barriers and costs to entry significantly, and every company needs to reassess those opportunities and risks themselves.”

Read the full article here.

Next week at the Flexible Facilities Event, Johannes Roebers, Ph.D., Executive Vice President, Head of Operations, Elan Pharma International Limited, Ireland will be on hand to present Current and Future Trends in Biopharmaceuticals: Biosimilars, Biosuperiors and Novel Biopharmaceuticals which will focus on the future of these therapies and how important it will be to have right manufacturing facilities to produce right amount of therapies through these up-to-date manufacturing facilities. For more information, download the agenda. If you'd like to join us, as a reader of this blog when you register to join us and mention code FF13JP, you'll save 20% off the standard rate.

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What are some of the drivers for flexible vaccine facilities?

The vaccine industry is seeing a rapid change in it's growth and markets it will be serving over the next decade.  Many of the large Asian countries and the developing world are seeing needs for vaccines at unprecedented numbers, and Pharma companies are will be forced to adapt the changing environment.  In this podcast with Tony D’Amore, Ph.D., Vice President, Bioprocess Research & Development, North America, Sanofi Pasteur, Canada, he looks at how Sanofi is coping with this change and looking towards flexible facilities to  to help scale back the cost.  Where fixed costs for large equipment are a usual worry, with flexible facilities producing single use technology, they are able to produce the number of vaccines needed in specific regions at a reasonable cost.

Listen to Dr. D'Amore's podcast here.

Dr. D'Amore will present the case study Increasing Flexibility in Vaccine Manufacturing Processes and Facilities with Disposable/Single-Use Technologies at IBC's Flexible Facilities event on Tuesday, April 2.  For more information about his case study and the rest of the program, download the agenda.  If you'd like to join Tony, as a reader of this blog when you register to join us an mention code FF12JP, you'll save 20% off the standard rate.

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