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BioProcess International Conference & Exposition

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Conference: October 26-29, 2015 * Exposition:  October 27-29, 2015 * John B Hynes Veterans Memorial Convention Center, Boston, MA


THE Industry Meeting Place to Exchange Real-World Solutions to Improve Speed, Cost and Quality

Conference: October 26-29, 2015 · Exhibition: October 17-19, 2015 · John B Hynes Veterans Memorial Convention Center · Boston, MA

BPI Post-Show Recap

BPI Post-Show Recap

BPI Post-Show Recap - BPI 2015 is the Biggest and Best Yet

The 12th annual BioProcess International (BPI) Conference & Exposition last week, was the largest in show history, reporting record attendance. With professionals from big pharma as well as large, mid-size and emerging biotech companies on-hand, a reported 1,750 attendees converged on the Hynes Convention Center in Boston, representing 36 states and 29 countries.

The burgeoning crowds reflected a 10% percent increase over last year. With 150 exhibitors and 165 presentations, plus countless networking opportunities, attendees were exposed to cutting-edge technology solutions aimed at advancing drug candidates closer to approval. The conference also featured over 110 peer-submitted scientific posters that were on display in the Exposition Hall, each delivering never-before-revealed findings that advanced industry objectives while bringing together great minds with those capable of transforming concepts into real life applications.

Leading event sponsors included GE Healthcare Life Sciences, Pall Life Sciences and Roche Custom Biotech. Each had a host of company experts onsite who contributed to the Technology Workshops. GE presented three workshops including Optimized and Consistent Protein Glycosylation in Biosimilar Production, Single-Use Fermentation: Understanding Process Economy and Process Performance, and An Insight into Recent Development in Protein A Chromatograpy. Pall Life Sciences experts addressed Automated iPSC Culture Process, Solutions to Process and Technology Bottlenecks and Evolving Cell Characterization Profiles in Moving Adult Stem Cells Toward Commercialization, and a review of Japan's new regulations and their impact on the industry. Experts from Roche Custom Biotech presented Critical Quality Attribute (CQA) Assessment - From Theory to Practice! and Raising the Bar: Advanced Analytics in Upstream Bioprocess Development. Other conference sponsors included 3M Purification, Bio-Rad Laboratories, EMD Millipore, Sartorius Stedim Biotech and Fujifilm Diosynth Biotechnologies.

A host of additional interactive exchanges addressed the latest topics of industry importance. Among the most well attended were the Ask the Regulators Open Forum, 15 Bioprocessing Problem-Solving Moderated Discussions, Town Hall Forums, and the always popular BPI Theater. Speakers addressed industry challenges and concerns, as well as regulatory perspectives on critical issues.

With all the activity, it proved to be a valuable experience for all who attended. Gary Pignata, co-founder of Apprentice Field Suite, said, "This was my first time exhibiting at BPI and it more than exceeded our expectations. Our new products received overwhelming interest. Everyone wanted to see how to use Remote Troubleshooting in BioPharma by trying on our Smart Glasses. I met with a variety of industry executives, from big pharma to emerging entities and was able to explain how we can tailor the product to their environment. I'll definitely be back next year!"

Fiona Barry, an editor with William Reed publications, travelled from Europe and reported on the conference for BioPharma-Reporter.com and Outsourcing-Pharma.com, including coverage of Tony Moody's address on a future HIV vaccine and a defense project creating battlefield bioreactors.

Perhaps the most anticipated part of the conference were the five keynote speeches by prominent industry leaders from Merck, Novartis, Duke University, Amgen, and Genzyme. Highlights from talks are below.

Keynote Highlights

This year's distinguished speakers hailed from some of the most highly-recognized companies and research institutions, both at home and abroad. A summary of the speakers and their topics are:

David J. Pollard, Ph.D., Executive Director, BioProcess Development, Merck & Co. Inc. -
Innovating mAb Production to Support the Immunotherapy Revolution

Dr. Pollard began the keynote session by stating it was an "exciting time in immunotherapy" and that a revolution is now underway in cancer treatment. To be successful in this revolution, the industry needs to be agile and flexible so it can quickly adapt to change.

He emphasized the importance of "collaboration between suppliers and end users" to help lower costs and increase throughput. "Working as a community, we can help create a facility of the future," he stated.

Such a "facility of the future" will create a tremendous opportunity to lower the cost of manufacturing while also being able to handle increased capacities, according to Dr. Pollard. He advocated a modular approach to develop these facilities so they can easily be built out as needed.

Dr. Pollard stated this next-generation manufacturing approach will improve acceleration to clinical trials and that technology will be used to de-bottleneck activities. This will create high-throughput workflows using enabled formulations from cell line development, process development (both upstream and downstream) and formulation.

Spencer Fisk, Global Head, Biologics Process R&D, Novartis Pharma AG, Switzerland -
Innovative Process Development Strategies to Drive the Rapid Clinical Introduction of Emerging Biologics

Fisk challenged the industry to go beyond the "heavily walked path" and push boundaries to speed drug development and improve efficacy. His advice to those seeking to accelerate drug development was to not avoid taking risks. He suggested to "use data to guide us" so scientists and engineers can approach the "edge of the cliff." Using data, risk levels can be determined and comfort levels established with the end result of more quickly selecting the proper candidate for development.

He further explained how choosing the best candidate requires evaluating all the variables such as the biology and the ability to develop the candidate. Each variable has its own elements. For example, in the case of biology, binding, potency and efficacy need to be assessed. In terms of development there are a number of aspects, including stability that need to be determined.

Risk factors should be classified as critical (red), moderate (yellow), and low (green), suggested Fisk. If the risks are predominantly low, then the candidate should be moved ahead. "Green means go," stated Fisk. The results will be favorable the majority of the time.

"If we get it right >80% of the time, we have significant time savings. In many cases, the 20% that does not work is simply due to the fact that more time is needed," said Fisk.

Taking this approach will create a cycle that will benefit the market, as well as society. Once scientists have "walked to the edge" and realized it was not as close as they originally believed they will push the boundaries further, creating a continuum of accelerating drug development, according to Fisk.

Michael Anthony (Tony) Moody, M.D., Chief Medical Officer, Associate Professor of Pediatrics, Duke Human Vaccine Institute (DHVI) -
Novel Approach to Developing and Producing Human Experimental Vaccines for HIV

Dr. Moody emphasized that because HIV is a unique and challenging virus it poses many challenges. Vaccines that are developed and aim to be effective must deal with an incredible diversity of circulating strains.

"By locating and neutralizing antibodies we can prevent disease but this is not an easy task. Antibodies at a sufficient level can target many strains of HIV1," said Dr. Moody.

One question posed by Dr. Moody during his session was whether or not the information gathered from patients who are currently infected can be used to make antibodies. "But it's not that simple. There are many changes to the immunosystem that we may need to mimic with adjuvants to be successful," he explained.

Novel adjuvants will need to be developed, according to Dr. Moody and human trials are in the planning stages, but there is no guarantee that the answers will be found. A paradox in the bnAb development is that mutations develop. As a result, Phase I human testing is required. Within that context, Dr. Moody stressed that two important elements are needed:

  • Targeting of multiple lineages
  • Multiple immunogens, likely in sequence

"Industry, academia and government will need to come together, as one of these alone cannot muster the resources needed to be successful," emphasized Dr. Moody.

Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd. -
Amgen's Next-Generation Biomanufacturing Facility

"The future is now" was the theme of Ms. Hall's address regarding Amgen's Next-generation Biomanufacturing Facility which was four years in the making and is scheduled to open in 2017. In changing the manner in which Amgen conducts bioprocessing manufacturing, the company is also re-shaping the entire industry, according to Hall.

"Whereas in the past, the focus was on high margins and capacity, today biomanufacturing is centered on cost, speed, and operation flexibility," she explained.

Hall shared the thoughts of Dr. Pollard of Merck when she spoke of a modular method for facility design.

"In a conventional facility design, capacity becomes a consideration in Phase II. That is not the case with a modular design, as it allows facilities to expand or contract as the market demands. Additionally, the modular format is agnostic to a country or location," she explained.

In addition to a modular format, the Amgen Singapore facility incorporates other design elements that have proven to create benefits in construction time, operations, and environmental footprint. Among those elements mentioned by Hall were integration of single-use technologies (95% of the equipment is single use), incorporating connected processing, and real-time and remote monitoring.

Hall explained that the disruptive approach taken by Amgen has cut the construction time of the Singapore facility in half and capital costs are one quarter that of a conventional facility. Operating expenses will be lowered by a third, as well, she said. The end result will be an approximately 60% reduction in protein development cost.

"One of the first questions I'm asked about is the environmental impact of the facility. I am happy to say that it will use less water for heating, cooling, and cleaning. Because it is a smaller facility, it will have a lower air quality classification, and emissions will be lower due to reduced energy usage and Singapore's cleaner energy," explained Hall.

Konstantin Kostantinov, Ph.D., Vice President, Technology Development, Genzyme -
What is the Future of Continuous Processing - What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?

He spoke of changes in upstream and downstream processes that will help create a "dominant design" in the next 5-10 years that will help shape bioprocessing.

"The commercialization of innovation will lead to a dominant design where almost any protein can be developed using a universal platform. It will take a lot of courage and focus to accomplish this dominant design," offered Dr. Konstantinov.

The dominant design outlined by Dr. Konstantinov is an end-to-end continuous integrated upstream and downstream principle. While there has been promising results in a pilot facility, Dr. Konstantinov noted, "Success is impossible without a high-performance cell line."

Thankfully, Dr. Konstantinov believes there is tremendous opportunity to improve cell lines. Success will be determined by three factors - stable productivity over a long period of time, stable quality over a long period of time, and low cell specific perfusion rate.

While upstream processing improvements are one step, Dr. Konstantinov expects "a lot of changes" in the downstream. He noted developments in equipment, and spoke of a large-scale continuous purification system with a very broad capacity range currently in a laboratory at Genzyme's Framingham, Massachusetts campus.

Despite all the progress, Dr. Konstantinov noted that the industry is entering a "very interesting stage." New technologies still need to be developed to fill a few gaps, including cell retention devices and viral inactivation.

He also suggested the industry broaden its approach to the integration of continuous processing. "Why stop at drug substance? We should also look at drug product because continuous manufacturing can bring advantages there, as well."

New Product Announcements

While the number of new product announcements at BPI 2015 were too many to list in their entirety, two interesting updates were presented by IDBS in the software category and Apprentice Field Suite in the new product category.

IDBS showcased its innovative software for data management in the bioprocessing industry. The company stressed the importance of products that are "bioprocess aware" and in showcasing their own offerings described key benefits that include the following:

  • Reduces repetition/duplication
  • Improves efficiency
  • Integrates data from a variety of sources
  • Compliance - reduces transcription errors

Innovative functionality of their software systems allows for the gathering of important data, which in the bioprocessing sphere means pulling important data from multiple sources such as instruments, online reactors as well as external observations.

Apprentice Field Suite (AFS) creates biopharma manufacturing and R&D solutions integrating cutting-edge technology via Smart Glasses with Augmented Reality (AR). AFS has four products that empower engineers and operators to free up their hands and utilize technology for remote collaboration, allowing them to be in two places at one time. The benefits include reducing downtime, improving accuracy and safety, and ultimately saving companies thousands of dollars.

The new suite of products are:

  • Tandem - creates a collaborative telepresence where a remote engineer can see the operator's field of vision in real-time, assist in troubleshooting without being on the plant floor and potentially save tens of thousands of dollars in lost manufacturing time. Also, live multi-site collaborative training can be done simultaneously from the perspective of the trainer.
  • Manuals - serves as a virtual instruction manual providing hands-free access to the latest standard operating procedures, batch records or job plans, eliminating costly errors due to incorrect procedures while increasing employee speed, efficiency and accuracy.
  • Gauge - utilizes computer vision to automatically alert an operator when a bioreactor is in-use before millions of dollars and countless hours are lost due to accidentally working on the wrong vessel. The tool has the capability to read and save analog and digital gauge values with optional photo/video capability.
  • Tracer - provides a unique solution for indoor location tracing. It can be used to create an employee, facility and process efficiency analysis when walking throughout a specific location.

As a reminder, BPI West, the West Coast's only bioprocessing event, will take place from March 14-17, 2016 in Oakland, CA. Visit the BPI West Web site for more details. In addition, be sure to mark your calendars for next year's BPI East event, taking place in Boston October 4-7, 2016.