The Standardization of Single-use Components for Bioprocessing

The focus in the bioprocessing industry is shifting from acceptance of single-use technology to standardization. It is critical that components be included in the standardization discussion. The tubing connector is essential for secure, sterile, leak-free connections between various single-use systems and processes. A user can have the best filter, bag and tubing but this is all pointless if the connector is not reliable, easy-to-use or robust. Improving connector compatibility and interchangeability are great opportunities for standardization, particularly because of complications related to managing inventories.

Inventory Issues

Several inventory issues arise from lack of connector standardization:

• Increased ordering complexity because the user must define which tube set or assembly works with which part of the application. 
• Greater risks of specifying the wrong system or connection, resulting in downtime and last minute adjustments at the end user site.
• Longer lead times because systems suppliers are manufacturing lower volumes of multiple SKUs as opposed to higher volumes of fewer SKUs. This lowers the incentive and likelihood for a manufacturer to stock of these items.
• Increased stocking requirements for end users, including connectors of different genders and other components needed to create make-shift adapters.

Reducing Overhead Costs: Less is More

While overhead cost reductions might be difficult to quantify, they cannot be overlooked. Reduction in SKUs and inventory lowers the cost of managing and maintaining that inventory, which allows capital to be allocated to additional process improvements. One way to help simplify and reduce inventory is to use genderless connectors that enable transitions between tubing of different sizes. Using genderless connections (e.g. CPC’s interchangeable AseptiQuik® G connectors) eliminate the need for reducer fittings elsewhere in the process as the connectors can act as reducers.

Component Standardization

By focusing on the most versatile genderless connectors, component standardization will help bioprocessing companies make the best use of single-use technology. The right connectors will enable end users to:
• Streamline operations with easy-to-use, robust sterile connections
• Eliminate potential ordering mistakes and reduce inventory demands related to gendered connectors • Maintain more flexibility and lessen production bottlenecks with onsite connector assembly 
• Reduce overhead costs, freeing up capital for other projects

Ultimately, standardizing components by incorporating single-use genderless connectors lets end users accomplish more with fewer finished goods, saving time and money, and getting their biopharmaceutical products to market more efficiently. 


Author: Todd Andrews, Global Sales and Business Development Manager, Bioprocessing for CPC – Colder Products Company

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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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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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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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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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Flexible Facilities LinkedIn

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Single Use Technology: Focus on Efficiency

Today, we feature a guest post from BioProcess International media partner PharmaManufacturing.com.  Want to join them at BioProcess International taking place this September 16-18, 2013, in Boston, MA? As a reader of this blog when you register to join us and mention code BLOG13JP and save 20% off the standard rate.

Focus on Efficiency

Single-use, analytical methods and downstream processing at the forefront.

The biopharma industry’s continued focus on process efficiency is being fueled by advances in biosimilars, smaller volume drugs, shorter drug lifecycles (faster trials, development cycles), and high-volume product manufacturing issues.

To evaluate the trends that are shaping the bioprocessing segment today, BioPlan Associates recently surveyed 450 global subject matter experts and senior participants on its Biotechnology Industry Council panel of bioprocessing professionals and asked them to identify the most critical factors and trends they expect will need to be addressed over the coming year. While ‘process efficiency’ was a unifying thread, three clear sub-topics emerged: downstream processing; analytical methods development; and single-use system integration. (1) This year, the industry will see an increase in multi-product facilities, selective single-use adoption (both in clinical and commercial stage), a ramping up of continuous processing, and more advanced automation and monitoring. With downstream processing continuing to lag improvements in upstream, the industry will continue to look for better performing chromatography resins and consider alternatives to protein A.

Downstream Processing
Downstream purification (separation, filtration and chromatography) continues to be a culprit behind facilities’ capacity constraint problems. It counts as one of the key areas that the biopharmaceutical industry believes must be addressed to avoid short- and long-term capacity constraints, and it is where a large number of industry suppliers and end-users are developing and evaluating new technologies and other options for improving production efficiency.

Biopharmaceutical manufacturing, due to the fact that it operates in a highly regulated environment, tends to be characterized by incremental improvements rather than rapid, major technology shifts associated with other less regulated or consumer-oriented industries. The problem has been that with the significant increases in protein expression levels over the past several years, pressure has shifted squarely to downstream operations, which have not seen the same degree of improvement. This, in return, has resulted in continued bottlenecks in purification and filtration operations. The issues experienced by downstream operators have remained relatively constant over the past few years. And although there are many new technologies under investigation and consideration, few as yet, are being actively implemented.

This year’s trends study revealed 24% of industry participants named downstream processing as the single most critical trend. By contrast, 5% said the same about upstream processing. Within the rather broad area of downstream processing, the research reveals several sub-trends including:f

• • Process improvements in bioburden control in chromatography columns;
• • Development of non-chromatographic recovery unit operations;
• • Improving harvest operations through novel technologies;
• • Increasing protein concentration in solution, without reducing yield; and
• • Purification related to impurity profiles in biosimilars.

There is a general perception that the industry needs better-performing chromatography resins. Results from last year’s 9th Annual Report and Survey of Biopharmaceutical Manufacturers2, in which more than 300 biomanufacturers were surveyed, showed that slightly less than one-third of respondents wanted suppliers to focus efforts on chromatography products, the third-most sought after new product development area of the 21 we identified. (2)

There appears to be some consensus that alternatives to protein A will continue to be sought and developed this year. It is worth noting that while the industry has been clamoring for alternatives to protein A purification for some time, few facilities have made such a switch. For example, last year’s survey revealed 16% of respondents considering alternatives to protein A for existing projects, but less than half that proportion (7%) offer that they will actually be moving away from protein A for existing scale-up or commercial production units over the following 12 months.

In fact, the study found that the long-term trend among facilities interested in protein A alternatives appeared to be decreasing for new production units, while there was modest interest in switching from protein A for existing scale-up and existing production units. In general, though, interest appeared to be waning.

Using protein A chromatography media remains problematic because of the high-cost, limited life of the material and the cost of cleaning/validation. Alternative methods for purification of antibodies have been, and are being developed with longer lifetimes and therefore lower cost per unit of protein produced. However, according to most end-users, protein A “works.” While general interest in alternate purification methods to protein A remain high, actual switching behavior seems to be static or declining.

Still, the environment is ripe for innovative alternatives to emerge, and as long as downstream processing remains in the conversation, alternatives to protein A will be an ongoing topic of discussion.

Analytical Methods
In most biomanufacturing segments, it appears that improvements in assays and analytical capabilities are needed or desired. In addition to the continuing needs to assess and document product composition and quality, new demands for assays and analytical capabilities for biosimilars range from proving similarity to determining the unique differences between products. Assays and analytical method improvements are also needed to increase productivity in active agent design, discovery, screening and optimization, as there are too many products continuing to fail very expensively later in development. Most all can agree that it’s preferable to have products fail fast in order to move on to the next, most promising candidate in the development pipeline.

Read the full article here.

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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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Single Use Session Spotlight: Single-Use Process Fit for mAb Production

Applying single-use technology has shown to lower costs and increase yield. How? Merck & Co., Inc. completed an end-to-end process fit using single-used technology for the production of monoclonal antibodies. Gain insights on single-use technology versus traditional stainless steel for process fits and facility designs. Dr. Jeffrey Johnson will be joining us at the Single-Use Applications Summit for Biopharmaceutical Manufacturing to present Single-Use Process Fit for mAb Production this June in Durham, North Carolina.

For more information on this session and the rest of the program, download the agenda. If you'd like to join us June 3-5, 2013, in Durham, North Carolina, as a reader of this blog when you register to join us and mention code SU13JP, you'll save 20% off the standard rate!

Featured Session:  Single-Use Process Fit for mAb Production

Featured Speaker: Jeffrey Johnson, MS, New Technology Lead, Merck & Co

About the session: A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.

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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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