BioProcess International: Biopharmaceuticals On Demand

The author from today's excerpt is Niels Haxthausen is Vice President of Sales and Marketing, NNE Pharmaplan

By 2016, five of the top 10 biopharmaceuticals are expected to be monoclonal antibodies (MAbs). Follow-on (biosimilar) versions of those blockbusters will most likely become available in later years due to patent expiry and the introduction of legislation for biosimilars around the world. Personalized therapies will drive the fractionation of the biopharmaceutical market, trending biomanufacturing toward smaller batch sizes and campaign-based production schemes.

A growing need for flexible, multipurpose, and cost-effective manufacturing will significantly affect the design of production facilities in the future. Demographic and market forces place China in a position to lead the way in this transformation of biopharmaceutical manufacturing.

“Compared with other biopharmaceutical products, MAbs are large proteins that require relatively high doses — and therefore traditionally necessitate high-volume manufacturing facilities,” explains Niels Guldager (senior technology partner in biopharmaceuticals for NNE Pharmaplan, a facility engineering and consulting company focused on pharmaceuticals and biotechnology). “Many biopharmaceutical facilities are still designed as traditional stainless steel facilities with fixed piping and tank layout and large bioreactor volumes. But such facilities require significant financial investment with total installation costs in the range of US$100–300 million.”

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 this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Lean Six Sigma

Our author from today's excerpt is Dr. Stephen C. Taylor, Vice President, Fujifilm Diosynth Biotechnologies 

About 10 years ago as a vice president of Avecia Biologics, I wrote an article for an early issue of BioProcess International looking ahead at likely changes in biomanufacturing (1,2,3). For the best part of the intervening period, Avecia Biologics and Diosynth slugged it out in the marketplace, each trying to grow its contract manufacturing business at the expense of the other. But in a life-altering two-year period between 2009 and 2011, both companies saw their realities and perspectives change:

• Schering Plough acquired Organon, the corporate owner of Diosynth.
• Merck/MSD acquired Avecia Biologics.
• Merck/MSD and Schering Plough merged, bringing Avecia Biologics and Diosynth under the same corporate ownership.
• Fujifilm acquired the two CMO businesses from Merck/MSD, brought them together, and challenged them to operate as a single truly global contract manufacturing organization (CMO).

Thus in April 2011 Fujifilm Diosynth Biotechnologies was born, with the Diosynth name retained to reinforce Fujifilm's long-term commitment to the CMO business. It has been an interesting experience to bring two similar competitors together and get them to operate as one effective business. Faced with the question of how to bring this about, we decided to seek some common denominators. Both businesses had already adopted the “lean six sigma” (LSS) concept as a catalyst for driving business change and improvement, so we had our first point of overlap.

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 this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Establishing Strategic Supplier Partnerships to Facilitate Manufacturing Success

Our authors from today's excerpt Robert Large, Senior Process Development Engineer, Grifols, Inc., Jared Ragone, New Product Development Engineer, Charter Medical, Ltd., Joe Petrosky VP of Global Sales and Marketing,Charter Medical, Ltd., Dominic Clarke, PhD, Product Manager, Cryogenic Storage and Cellular Therapy, Charter Medical, Ltd. 

In November 2009, Talecris Biotherapeutics announced an ambitious US$269 million expansion of its Clayton, NC, manufacturing facility. The company was subsequently purchased by Grifols, Inc. in 2011. Constructing a new facility with a state-of-the-art manufacturing process intended to generate clinical products involves top-notch project management, exceptional fortitude, and numerous supply chain decisions. Suppliers are often relied on to provide standard product support. When used effectively, they can be an invaluable resource beyond basic services. Additional support may include engineering expertise, custom device development, and even regulatory insight.

Forming strategic partnerships with the right suppliers is important to preventing critical-path project delays. When a biopharmaceutical company builds a new manufacturing facility and implements a novel process design, not all suppliers are willing or able to provide the necessary product support in the time required. As a leading provider of plasma-derived therapeutic components, Grifols relies on quality partnerships to achieve its complex production goals. Below is a case study of the key partnership between Grifols and single-use systems (SUS) supplier Charter Medical, Ltd. (CML), of Winston-Salem, NC. The output of this alliance was development and implementation of a crucial SUS processing component in time to keep the new facility's opening on schedule.

Background


Headquartered in Barcelona, Spain, Grifols is a multinational healthcare company. This principal producer of blood-plasma–based products also supplies devices, instruments, and reagents for clinical testing laboratories. The company is a major world supplier of intravenous immunoglobulin (IVIG), albumin, blood factor VIII, and other plasma-derived products. The global bioscience division of Grifols is committed to hemotherapy and producing life-saving protein therapies, with a standing mission to improve the health and well-being of patients around the world. These hemotherapeutic products are derived from human plasma, the liquid portion of human blood that contains essential proteins for treating rare, chronic, and life-threatening conditions (immune deficiencies, bleeding and blood-clotting disorders, alpha-1 antitrypsin deficiency, and so on) (1).

Grifols built a leading-edge plasma fractionation manufacturing facility in Clayton, NC, where the company is implementing and upgrading the proprietary centrifugation process it uses to obtain the plasma fractions. During installation qualification (IQ), Grifols encountered an issue with an SUS component necessary for the processing and storage of the precipitated fractions. Process development engineers reached out to CML for assistance.

CML has an ISO 13485 certified manufacturing facility located in Winston-Salem, NC. The company's vital fluid business serves bioprocessing and medical device customers. It designs and supplies both standard and custom SUS for processing cell-based and biologic fluids in biotech and clinical applications.

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 this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!

Share this article with your social network, just click below to share now!

Share |

Highlights from Flexible Facilities Podcast Featuring Abdullah Baaj

Today's podcast features Abdullah Baaj, CEO, Boston Oncology. Baaj discussed regulatory experiences, planning and designing space in multiple countries and flexible facility design and capacity requirements. 


So, Abdullah, why did you choose to set up flexible facilities?

Abdullah: Well, this is a question that we get often when people speak to us about the facility type and the design. So, let’s step back and consider that, traditionally speaking, biologic products have been manufactured in larger facilities with stainless steel bioreactors, they usually had a fixed and inflexible processing, I’m talking about downstream processing. All of that led to complex cleaning and sterilization challenges. Most often, these facilities had a single product production intention. But, if you look at more recent trends, the trend is for smaller facilities, flexible facilities and cost-effective facilities. So, this is just the background of the industry.

What challenges have you encountered setting up flexibility facilities in countries outside of the US?

Abdullah: I want to emphasize that at this point, we have not actually built any specific facility. We are in the planning and more the design space because we are building in multiple countries. With that in mind, there are two things to consider – local factors and common factors.


Download the full podcast.

Join Abdullah 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!

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Toward Flexible Hybrid Facilities of the Future

Today's authors are Jeffery Lee Craig is Global Director of Business Development and Marketing, ATMI LifeSciences and Michael Jenkins, General Manager, Catalent Pharma Solutions

As the bioprocessing industry has shifted away from traditional stainless steel bioreactors and vessels toward single-use technology, a new breed of manufacturing facilities has arisen. Flexible facilities take full advantage of traditional multiuse technologies and combine them with increasingly popular single-use technologies, offering an ability to mitigate risk and decrease manufacturing timelines. Although some companies have made the choice to remain strictly traditional (multiple use) and others have moved fully into single use, the flexible hybrid format gives manufacturers the “best of both worlds.” That paves the way for a new and more effective approach to bioprocessing.

Here, we discuss the definition of a flexible facility and why Catalent Pharma Solutions chose to go with such a format. It partnered with ATMI LifeSciences throughout the process of moving from a 43,000-ft2 facility in Middleton, WI, to a 100,000-ft2 site in nearby Madison, WI. The Wisconsin production facility houses Catalent's proprietary GPEx technology (for mammalian cell line engineering) for rapid engineering of stable mammalian cell lines that express biopharmaceutical proteins. Typical fed-batch processes give a high production concentration of 2–5 g/L. The facility also offers process development, analytical development, and current good manufacturing practice (CGMP) manufacturing with GPEx and other mammalian cell lines. The current facility allows recombinant proteins to be manufactured in small vessels (up to a 200-L scale) for the CGMP production of phase 1–2 clinical trial supplies using traditional stainless steel bioreactors.

Background
 The original expansion of the Middleton facility was in planning about five years ago, when necessary conventional stainless steel bioreactors (up to a 2,000-L scale) were purchased. However, that project was put on hold during the economic down-turn, and it was revisited only a couple years ago once demand began to reach available capacity. Rather than simply implement the original expansion design, however, Catalent took time to return to the drawing board and decided to create a fully flexible facility in a nearby available building. That structure had a large open area that would be ideal for build-out of CGMP suites, but it lacked the infrastructure required for stainless steel bioreactors (e.g., for delivery of clean steam). During the initial evaluation, purchases that had been made already were kept in mind along with considering the advantages of single-use technologies on the market. Catalent already had extensive experience with disposables, having used Wave bioreactors from GE Healthcare as part of its CGMP seed train as well as bioprocessing bags for buffer preparation and storage of process intermediates.

To implement the original plan in stainless steel with a fixed plant would have involved the cost of additional piping for steam-in-place (SIP) systems as well as expensive support equipment for clean-in-place (CIP) systems. Catalent determined that building a facility that would rely on single-use vessels would require other infrastructure upgrades, but that elimination of fixed pipework would lower those costs and leverage established advantages of disposables to the facility. Factors such as a decreased risk of cross-contamination, faster suite turn-over between production runs, and shortened construction time helped to solidify the final decision. Catalent chose to sell its unused stainless steel reactors — they had not even been unpacked — and purchase single-use reactors to carry out production runs.

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 this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Developing an Integrated Continuous Bioprocessing Platform

Our excerpt today is by Maribel Rios,Managing Editor, BioProcess International .

Continuous upstream processing (perfusion) is not a new concept in the bioprocessing industry. Genzyme, Bayer, Centocor, and other companies have been implementing perfusion processes for many years. However, interest is now growing for extending this concept to downstream operations to create fully integrated continuous processing. During the past year, Genzyme has presented on and published about its advancement toward the development of an integrated continuous system (1). The company has completed proof-of-principle development at laboratory scale with different molecules, and the results, says Konstantin Konstantinov (vice president, commercial process development) have been “highly successful and very exciting.” I spoke with him about the technologies involved in a completely integrated continuous process and how it may affect the design of future facilities.

BPI: What are the first steps toward developing a continuous process?

KK: Our starting point is to focus on the process objectives first and then think about the facility. The process is the driver. We want to design a process that is universal, flexible, and very standardized. At the end of the day, we want to have a platform that can be used for any therapeutic protein. This is generally what happens in many industries when they mature: They come up with one harmonized process, often referred to as “the dominant design.” This is what Genzyme is trying to develop — the dominant design of the future.

BPI: How does a continuous upstream process affect downstream?

KK: The downstream conversion into continuous is more interesting than the upstream. I started working on perfusion processes more than 25 years ago, so it is not something that is very unique or that the biotechnology industry recently invented. It is improving, however, because we are using better cell lines, better media, and better cell-retention devices that allow us to operate at very high cell densities.

The newer concepts are in continuous downstream operation. Genzyme has converted the first step (capture) into continuous processing. It is directly integrated with the perfusion cell culture process without any equipment between the two operations. So the harvest hold tanks, microfiltration, and centrifuges, are all removed.

Downstream steps are integrated with the upstream steps; all the flow rates are adjusted to be the same. Integration requires that harvest coming out from the perfusion bioreactor is continuously loaded onto the capture columns directly. It should be compatible with the pH, osmolality, and other parameters without many adjustments. We try to ensure that cycle times and hold times are minimized or completely eliminated for rapid processing, which is especially beneficial for proteins that are sensitive to degradation during any hold steps.

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 this February. To learn more, view our agenda. Register with code FLEX14BLOG and save 20% off of the standard rate.We hope to see you February 24-25 in Berkley, CA!

Share this article with your social network, just click below to share now!

Share |

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.

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Multiproduct Facility Design and Control for Biologics

Today's excerpt has been provided by Bo Chi, FDA CDER, Julia Edwards,Genentech, Jun Park, FDA CDER Stefanie Pluschkell, Pfizer , Nancy Waites, FDA CDER, Elizabeth Yamashita, Savient Pharmaceuticals, Siddharth Advant, ImClone Systems, Wassim Nashabeh,Genentech, Lorna D. McLeod, BioProcess International. 

Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans.

A Chemistry, Manufacturing, and Controls (CMC) Strategy forum was held in Bethesda, MD, in August 2011 to highlight various challenges, risks, and control strategies associated with multiproduct facilities. Multiproduct strategies for the manufacture of a variety of product types at different life-cycle stages and potentially using different host cells were presented with case studies. Experts from both industry and global health authorities discussed facility design considerations as well as procedural controls such as cleaning validation and product testing. The importance of quality risk management (QRM) to multiproduct operations and controls was also discussed using practical examples of risk-based approaches to meet the challenges of multiproduct manufacturing. Session 1: Design Considerations

What are the principal challenges in building a flexible, scalable, multiproduct manufacturing network?

The biotechnology environment is changing. Unprecedented yields are now the norm, but smaller batch sizes are needed to accommodate increasingly personalized medicines. New expression technologies such as transgenics will require different dosage forms. Rising expectations for sponsors to build quality into their manufacturing processes rather than relying on end-product testing are resulting in a changing paradigm for validation activities and life-cycle risk management. Competitive pressure from biosimilars will require keeping cost of goods as low as possible without sacrificing quality.

Decisions must be based on comprehensive global and regional business and regulatory strategies as defined by each company — sponsors and contract manufacturing organizations (CMOs). That task can be complicated by many factors, including, for example, differing regulatory interpretations in different jurisdictions. In addition, appropriate records have to be maintained. If there are multiple products and multiple jurisdictions involved, the record-keeping can become extremely complex. Manufacturing challenges arise from the difficulty of working with newer- and older-generation products in multiple regions and within multiple product categories. Manufacturers must also keep up with guidances in multiple regions for multiple products, which is not a simple and straightforward undertaking.


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.

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Flex-Facilities Multiproduct Designs - Safety, Flexibility, and Efficiency

Our excerpt today is by Bernd Stauss, VP, Production & Engineering, Vetter Pharma-Fertigung GmbH & Co.

International pharmaceutical and biotech companies are demanding solutions for current and future challenges of their industries — solutions that will stand the test of time while offering significant advances over current manufacturing techniques. Modern and highly proficient production lines for commercial manufacturing of parenteral drugs can represent a crucial criterion in the success of these companies. New and innovative high-speed filling lines for prefilled syringes present an excellent opportunity to meet current production demands. Following is an example of how the latest filling technology fits in.

Creativity is critical for sustaining new solutions, but it can often be constrained. The global market for medications involves demands from a number of sources. For example, guidelines from official regulatory agencies are becoming stricter as drug patents are expiring. Meanwhile, competition is becoming fiercer, as are pressures on price. Original manufacturers of biopharmaceuticals faced with spending immense costs to develop and manufacture such products face competition from biosimilars. 

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 Berkley, CA. To learn more, view our agenda.

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Inactivated Poliovirus Vaccine Made in Modular Facilities with Single-Use Technology

Our excerpt today has been provided by Adriana G Lopes, Managing Director, LLB Global Health Solutions Ltd. in London, UK, Andrew Sinclair, Managing Director, Biopharm Services, and Nigel Titchener-Hooker, Director, Advanced Centre of Biochemical Engineering, Department of Biochemical Engineering at University College London. 

If current efforts to eradicate polioviruses worldwide are successful, then the oral poliovirus vaccine (OPV) currently used for routine immunization in low- and middle-income countries (LMICs) will be replaced by inactivated poliovirus vaccine (IPV). IPV will become the only option for such countries if they want to continue to vaccinate against polio (1). Because IPV is currently considered to be too expensive for use in LMICs, strategies are being undertaken to make IPV more affordable (2). Some experts estimate that in 5–10 years there will be a lack of IPV manufacturing capacity worldwide (3). That will most affect LMICs, which depend on external vaccine supplies. So expansion of existing facilities (or building new ones) will be key to meet future demand. Here we examine the use of alternative technologies such as modular manufacturing facilities and single-use equipment as means to improve IPV affordability and capacity.

Figure 1: 

Main Drivers for Implementation of Modular Facilities and Disposables in Vaccine Production: One major argument for modular facilities is their time savings over a conventional construction approach (4). Even though the initial cost for using modular facilities exceeds that of conventional methods, an assurance of predictable outcome and time savings provides earlier return on investment for clear cost savings. Time is saved by conducting activities in parallel, which allows for significant compression of tasks (Figure 1). With all construction undertaken in a controlled environment, results are consistent and quality is enhanced. Equipment installed within each module (at its final operating location) will require no reassembly or extensive retesting. The building and fit-out of modules to good manufacturing practice (GMP) specifications in an external environment provides further benefit when applied to LMICs because technical skills required to complete and validate a facility to suitable specifications would not be required within the country itself.

Figure 1:  (Click to enlarge)

Single-use technologies typically allow for a simpler facility design than their stainless-steel counterparts because complex clean-in-place (CIP) and steam-in-place (SIP) systems are no longer required to support the equipment between operations. So disposables facilitate faster design, construction, and commissioning of facilities as well as offering manufacturing flexibility through the reconfiguration of manufacturing suites. A smaller, less complicated facility can be built, commissioned, qualified, and validated in 12–18 months rather than four years (5).
The scale of viral vaccine production is generally smaller than that of many other processes (ranging 500–2,000 L), so known limitations of scale involved with single-use technologies (max 2,000 L) can be advantageous for this application. Compared with traditional approaches, single-use technology offers many benefits for vaccine manufacturing (6, 7):

• Fast turnover maximizes facility output (no CIP or SIP operations).
• Reduction of capital investments is linked to reduction and simplification of facility design and to lowered equipment investment.
• Viral production must be handled in a biosafety containment level 3 environment. Single-use technology simplifies production areas because of smaller equipment footprints, lower ceiling heights, and elimination of water-for-injection and steam utilities.

Our aim is to evaluate the potential of using these alternative technologies — modular facilities and single-use technology — for affordable and sustainable IPV production in LMICs.

View the full article here. BPI will be joining us February 24-25 for the 2nd Annual Flexible Facilities Conference in Berkley, Ca. To learn more, view our agenda.

Share this article with your social network, just click below to share now!

Share |

8 Case Studies of Facility Implementation & Lessons Learned:

Register Today for a Look at State-of-the-Art Facilities, Technologies and Processes to Optimize Your Future Production Needs. View our case studies below:

• 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

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

• Implementing New Flexible and Single-Use Devices and Processes for Vaccine Manufacturing: Case Study on Formulation and Filling Kirsten Strahlendorf, Senior Scientist, Sanofi Pasteur, Canada

• Flexibility Defined: A Case Study on Multi-Product, Multi-Technology Vaccine Manufacturing Facilities Andrew Strong, President and CEO, Kalon Biotherapeutics

• Single-use Mixing Systems in Large-scale Live-viral Vaccine Upstream Processes Daniel C. Vellom, Ph.D., Sr Director, Biotechnology Expert, Global Technology Innovation, Sanofi Pasteur Biologics, LLC

• Increasing Control and Flexibility for Development and Manufacturing Processes Sebastien Ribault, Ph.D., Director, Bioproduction and Development, Merck Millipore, France

• Single Use Systems – An End User’s Perspective Alex Tschumakow, Director, Manufacturing, Shire

• Implementing and Improving Disposable Systems Chris M. Brodeur, Associate Director, Commercial Operations, BioMarin

To learn more, view our full agenda.

 Register by 1/17 with priority code FLEX14BLOG and save $200 off of the standard rates. 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

Opt-in for updates
Follow us on Twitter
Flexible Facilities LinkedIn

Share this article with your social network, just click below to share now!

Share |

BioProcess International: Enhancing Manufacturing and Development Efficiency

Today we feature an excerpt from Maribel Rios, Managing Editor, BioProcess International 

Multiproduct facilities face additional optimization requirements associated with handling several approved products and drug substances at one site, including multiple technology transfers. Flexibility is vital for such companies. In his Tuesday presentation, Markus Wollenberg of Boehringer Ingelheim Pharma will describe how manufacturers deal with a wide range of processes (e.g., low-titer legacy and high-titer state of the art) and tech transfer projects. “Each project has its own set of priorities regarding speed, project cost, cost of goods, and risk,” he points out. His presentation will include examples of typical challenges found in multiproduct facilities and their corresponding solutions.

One well-recognized challenge in multiproduct facilities is minimizing or eliminating cross contamination. For that, industry and regulatory experts have advised manufacturers to take a risk-based approach. Such strategy can prove beneficial in flexible layouts in sites working with combinations of products, product classes, and host-cell types. In their presentation, Stephen Reich and Kristin Murray of Pfizer will share practices for selecting quality risk-management tools to identify and control cross contamination hazards across various facility designs and multiproduct operating schemes.

Paul Slaman of Shire Human Genetic Therapies will detail an example of a single-use/flexible approach to facility design. The approval of Shire's new Lexington (MA) manufacturing facility earlier this year marked a milestone in the company's implementation of single-use systems design. Slaman will provide an inside look at those systems and how the plant was designed to accommodate the growing variety of the company's therapeutic proteins.

Rizwan Sharnez of Amgen will present a case study on cleaning validation, with a focus on using cleaning characterization to streamline new product launches (coauthors Michelle Monk, Laura Klewer, Chris Flint, and Arun Tholudur, all ofAmgen). Manufacturers need strategies for addressing cleaning validation challenges for bioprocesses. According to Sharnez, such strategies “are rooted in systematic and proactive approaches to cleaning.” Examples of such approaches include small-scale “cleanability studies” to minimize at-scale cleaning validation studies, master soils to streamline and provide flexibility for scheduling cleaning validation activities, and inactivation studies to obviate the need for product-specific assays and maximum allowable carryover (MAC) assessments.

You can view the full article here. BPI will be joining us February 24-25 for the 2nd Annual Flexible Facilities Conference in Berkley, Ca. To learn more, view our agenda.

Share this article with your social network, just click below to share now!

Share |

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

Today we feature an excerpt from corresponding author Howard L. Levine, Founder, 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. 

You can view the full article here. BPI will be joining us February 24-25 for the 2nd Annual Flexible Facilities Conference in Berkley, Ca. To learn more, view our agenda. 

Share this article with your social network, just click below to share now!

Share |

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!

Share this article with your social network, just click below to share now!

Share |

Take Part in 2 Interactive Flexible Facility Discussions

IBC’s Flexible Facilities brings together senior level executive and scientists from biopharmas, CMO’s, technology providers, engineering firms and regulatory groups to explore the changing landscape of biologics manufacturing - so what better place to get all the answers you need and take part in these two interactive discussions! 

Functionally-Closed Processing in CNC Environments: What is Holding Us Back? 

• What defines a closed system? 

• How closed is closed in a closed system process? 

• Regulatory perspectives in closed systems 

Panelists: 

Marc Pelletier, Ph. D., Directory of Biotechnology, CRB Consulting Engineers 

Scott Probst, Ph.D., Group Head, HealthCare and Biotechnology, Bayer Technology Services, Germany Sebastien Ribault, Ph.D., Director, Bioproduction and Development, Merck Millipore, France 

Where Do You Have to Compromise When Designing and Implementing a Flexible Facility? 

• What facility design criteria are most important for your product portfolio? 

• How to balance optimal facility needs with accelerated timelines and limited resources? 

• What compromises should you never make when designing your facility? 

Moderator: 

R. Thomas Warf, Director, Manufacturing, Facilities & Engineering, BARDA, U.S. Department of Health & Human Services 

Panelists: 

Chris McDonald, Site Head, Holly Springs Site, Novartis Vaccines and Diagnostics 

Vijay Yabammavar, Ph.D., Senior Vice President, Manufacturing Operations and Process & Analytical Development, Emergent BioSolutions 

Andrew Strong, President and CEO, Kalon Biotherapeutics 

Andrew Graham, Senior Director, Operations-Manufacturing, Nanotherapeutics, Inc. 

Want to learn more? Download our 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 

Opt-in for updates

Follow us on Twitter

Flexible Facilities LinkedIn Group

Share this article with your social network, just click below to share now!

Share |